A Phase 2 interventional study of IMU-838 and Placebo in Ulcerative Colitis, sponsored by Immunic AG. Terminated at 131 sites in 19 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Immunic AG · Phase 2, Interventional, and Treatment
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy with an option for open-label treatment extension in moderate-to-severe ulcerative colitis (CALDOSE-1).
The investigational medicinal product (IMP) IMU-838 (vidofludimus calcium) is a new compound that selectively inhibits the human enzyme dihydroorotate dehydrogenase (DHODH). Dihydroorotate dehydrogenase plays a major role in the de-novo pyrimidine synthesis and is specifically expressed at high levels in proliferating or activated lymphocytes. Resting lymphocytes satisfy their pyrimidine requirements through a DHODH-independent salvage pathway. Thus, IMU-838-mediated DHODH inhibition selectively affects activated, rapidly proliferating lymphocytes. The metabolic stress secondary to DHODH inhibition leads to a reduction of pro-inflammatory cytokine release including interleukin (IL)-17 (IL-17A and IL-17F) and interferon gamma (IFNγ), and to an increased apoptosis in activated lymphocytes.
This is a phase 2, multicenter, randomized, double-blind, and placebo-controlled trial in patients with moderate-to-severe UC with an option for open-label treatment extension. The study comprises a blinded induction phase to establish the optimal dose of IMU-838 to induce response and remission, a blinded maintenance phase to evaluate the potential of IMU-838 to maintain remission until Week 50, and an open-label treatment extension arm for all patients who discontinue the blinded phase as scheduled or prematurely, subject to certain restrictions. A subset of patients will undergo a pharmacokinetic (PK) period at the start of the open-label period to establish a full single-dose PK profile.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's enrollment of 263 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Immunic AG is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Induction phase
Previous treatment failure defined as:
Active disease defined as
a. Mayo stool frequency score of ≥2 at Screening Visit 1 b. Mayo rectal bleeding score of ≥1 at Screening Visit 1 c. modified Mayo endoscopy subscore of ≥2 at the screening flexible sigmoidoscopy (endoscopy assessed by an independent central reader blinded to screening center and patient information)
Female patients must:
a. Be of non- i.e. surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before Screening) or (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or
b. If of child-bearing potential, must have a negative pregnancy test at Screening (blood test) and before the first study drug administration (Day 0 urine test). They must agree not to attempt to become pregnant, must not donate ova, and must use a highly effective method 2 months before Screening, during treatment with IMU-838, and at least 3 months after the last dose of study therapy
Highly effective forms of birth control are those with a failure rate less than 1% per year and include:
Male patients must also either
For Poland and the UK the following additional requirement apply:
And additionally, for Poland only:
Maintenance phase
Open-label treatment extension arm
OR
Patient is in the extended induction phase, had completed all Week 10 assessments, and has not reached symptomatic remission during or at the end of the extended induction phase, Or Patient is in the maintenance phase and discontinues from the maintenance phase due to symptomatic UC relapse or other reasons with a flexible sigmoidoscopy performed at discontinuation (if the previous sigmoidoscopy had been performed more than 4 weeks before discontinuation)
OR
Patient has completed the maintenance phase as scheduled (including all Week 50 assessments)
EXCLUSION CRITERIA:
Gastrointestinal exclusion criteria
History of colorectal cancer or colorectal dysplasia (with the exception of dysplasia in polyps which have been removed)
Infectious disease exclusion criteria
Clostridium difficile (C. difficile) infection
Other chronic systemic infections
Any within 30 days prior to study drug administration except for the influenza vaccine
Other medical history and concomitant disease exclusion criteria
Concurrent or prior malignancy within the previous 10 years except for the following: adequately-treated non-melanoma skin cancer and adequately-treated cervical cancer
Therapy exclusion criteria
Use of the following medications within 2 weeks before first randomization:
Use of the following medications within 4 weeks before first randomization:
Use of biologics as follows:
Use of the following concomitant medications is prohibited at Screening and throughout the duration of the trial:
General exclusion criteria
Exclusion criteria for open-label treatment extension arm
Significant protocol deviations during induction and/or maintenance phase that are assessed by the investigator to negatively affect further patient cooperation in this study
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two 5 mg tablets once daily of IMU-838 for 10 to 22 weeks depending on symptomatic remission at Weeks 10 or 22. Patients will receive only half of their assigned full dose during the first week of treatment.
Drug: IMU-838
Two 15 mg tablets once daily of IMU-838 for 10 to 22 weeks depending on symptomatic remission at Weeks 10 or 22. Patients will receive only half of their assigned full dose during the first week of treatment.
Drug: IMU-838
Two 22.5 mg tablets once daily of IMU-838 for 10 to 22 weeks depending on symptomatic remission at Weeks 10 or 22. Patients will receive only half of their assigned full dose during the first week of treatment.
Drug: IMU-838
The placebo tablets will be identical to the IMU-838 tablets in terms of appearance, constitution of inactive ingredients, and packaging.
Drug: Placebo
Two 5 mg tablets once daily of IMU-838 until Week 50 or ulcerative colitis relapse.
Drug: IMU-838
Two 15 mg tablets once daily of IMU-838 until Week 50 or ulcerative colitis relapse.
Drug: IMU-838
The placebo tablets will be identical to the IMU-838 tablets in terms of appearance, constitution of inactive ingredients, and packaging. Patients who have received placebo during the induction phase will be 're-randomized' to continue to receive placebo (in a blinded fashion).
Drug: Placebo
Two 15 mg tablets once daily of IMU-838 or one 30 mg tablet IMU-838 once daily for up to 10 years and up to 3 years in UK sites
Drug: IMU-838
IMU-838 tablet
Also known as: IM90838, vidofludimus calcium
Tablets manufactured to mimic IMU-838 tablets
Also known as: Placebo (for IMU-838)
Induction Phase: Symptomatic Remission and Endoscopic Healing at Week 10
Composite endpoint: Proportion of patients with both, symptomatic remission (Mayo rectal bleeding subscore = 0, and Mayo stool frequency subscore of 0 or 1) and endoscopic healing (Modified Mayo endoscopy subscore of 0 or 1) at Week 10. All patients who were randomized to 30 mg/day and 45 mg/day were used for the assessment of the primary efficacy endpoint
Time frame: 10 weeks
Induction Phase: Symptomatic Remission and Endoscopic Healing at Different Doses at Week 10
Proportion of patients with both symptomatic remission and endoscopic healing at Week 10 (all individual IMU-838 doses were compared with one another and to placebo)
Time frame: 10 weeks
Induction Phase: Symptomatic Remission
Proportion of patients achieving symptomatic remission (Mayo rectal bleeding subscore = 0, and Mayo stool frequency subscore of 0 or 1) during the induction phase
Time frame: 22 weeks
Induction Phase: Time to Achieving Symptomatic Remission
Time to achieving symptomatic remission (Mayo rectal bleeding subscore = 0 and Mayo stool frequency subscore of 0 or 1) within the extended induction phase
Time frame: 22 weeks
Induction Phase: Proportion of Patients With Clinical Response
Proportion of patients with clinical response (decrease from Baseline in the full Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1) at Week 10
Time frame: 10 weeks
Induction Phase: Proportion of Patients With Endoscopic Healing
Proportion of patients with endoscopic healing (Modified Mayo endoscopy subscore of 0 or 1) at Week 10
Time frame: 10 weeks
Induction Phase: Proportion of Patients With Symptomatic Response
Proportion of patients with symptomatic response (≥1-point decrease from Baseline in Mayo PRO-2 score) during the induction phase (including extended induction phase)
Time frame: 22 weeks
Induction Phase: Full Mayo Score
Change in full Mayo Score from Baseline to Week 10. The full Mayo score is composed of 4 categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) each rated from 0 to 3 that are added up to give a total score that ranges from 0 to 12. A higher score indicates a worse outcome.
Time frame: 10 weeks
Induction Phase: Partial Mayo Score
Change in partial mayo score over 10 or 22 weeks. The partial Mayo score includes only the non-invasive Mayo subscores, ie, stool frequency, rectal bleeding, and physician's global assessment (each rated from 0 to 3 that are added up to give a total score that ranges from 0 to 9). A higher score indicates a worse outcome.
Time frame: 22 weeks
Induction Phase: Patient Reported Outcome (PRO)-2 Mayo Score
Change in PRO-2 Mayo score over 10 or 22 weeks. Mayo PRO-2 score, ie, stool frequency and rectal bleeding score each rated from 0 to 3 that are added up to give a total score that ranges from 0 to 6. A higher score indicates a worse outcome.
Time frame: 22 weeks
Induction Phase: Fecal Calprotectin (fCP)
Time course of biomarker fCP in stool samples during extended induction phase
Time frame: 22 weeks
Induction Phase: C-reactive Protein (CRP)
Time course of biomarker CRP in blood samples during extended induction phase
Time frame: 22 weeks
Safety: Adverse Events
Incidence and Severity of AEs during the induction and maintenance phases
Time frame: 50 weeks
Safety: Number of Participants With Clinically Significant Findings During Physical Examination
The emergence of any clinically significant findings compared to screening captured during the induction and maintenance phases
Time frame: 50 weeks
Safety: Body Weight
Changes in body weight during the induction and maintenance phases
Time frame: 50 weeks
Safety: Blood Pressure
Changes in blood pressure (mm Hg) during the induction and maintenance phases
Time frame: 50 weeks
Safety: Heart Rate
Changes in heart rate (beats per minute) during the induction and maintenance phases
Time frame: 50 weeks
Safety: 12-lead Electrocardiogram (ECG)
Number of patients with clinically significant changes in ECG
Time frame: 50 weeks
Safety: Hematology
Number of participants with abnormal hematology laboratory values (treatment-emergent adverse events \[TEAEs\] related to hematological abnormalities)
Time frame: up to Week 50
Safety: Blood Chemistry
Number of participants with abnormal blood chemistry laboratory values (TEAES related to clinical chemistry abnormalities)
Time frame: 50 weeks
Safety: Coagulation
Number of participants with clinically significant abnormal coagulation laboratory values
Time frame: 10 weeks
Safety: Urinalysis
Number of participants with abnormal urinalysis laboratory values (TEAEs related to urinalysis)
Time frame: 50 weeks
Safety: Micro Ribonucleic Acid-122 Expression
Micro ribonucleic acid-122 (miR-122) expression (before first dose and 24 hours after first dose - foldchange of normalized expression values )
Time frame: 24 hours
Pharmacodynamics (PK): IMU-838 Trough Level
Measurement of pre-dose (trough) blood plasma levels of IMU-838 throughout the induction period
Time frame: Day 0, Day 1, Day 7, Week 2 and Week 10
PK: IMU-838 Plasma Level
Measurement of post-dose blood plasma levels of IMU-838 at Week 2
Time frame: 2 weeks
PK: Area Under the Drug Concentration-time Curve (AUC) From Time Zero to 24 Hours (AUC0-24h)
Single-dose PK measurement of AUC0-24h in a subset of patients in the open-label phase
Time frame: pre-dose, 1, 2, 3, 4, 5, 6 hours post PK dose; 24 hours post PK dose; 48 hours post PK dose; 72 hours post PK dose
PK: AUC Time Zero to Last Measurable Concentration (AUC0-t)
Single-dose PK measurement of AUC0-t in a subset of patients in the open-label phase
Time frame: pre-dose, 1, 2, 3, 4, 5, 6 hours post PK dose; 24 hours post PK dose; 48 hours post PK dose; 72 hours post PK dose
PK: AUC Time Zero to Infinity (AUC0-inf)
Single-dose PK measurement of AUC0-inf in a subset of patients in the open-label phase
Time frame: pre-dose, 1, 2, 3, 4, 5, 6 hours post PK dose; 24 hours post PK dose; 48 hours post PK dose; 72 hours post PK dose
PK: Maximum Plasma Concentration (Cmax)
Single-dose PK measurement of Cmax in a subset of patients in the open-label phase
Time frame: pre-dose, 1, 2, 3, 4, 5, 6 hours post PK dose; 24 hours post PK dose; 48 hours post PK dose; 72 hours post PK dose
PK: Time to Cmax (Tmax)
Single-dose PK measurement of Tmax in a subset of patients in the open-label phase
Time frame: pre-dose, 1, 2, 3, 4, 5, 6 hours post PK dose; 24 hours post PK dose; 48 hours post PK dose; 72 hours post PK dose
Maintenance Phase: Proportion of Patients in Symptomatic Remission
Proportion of patients in symptomatic remission (Mayo rectal bleeding subscore = 0, and Mayo stool frequency subscore of 0 or 1) by visit up to Week 50 in maintenance phase
Time frame: Week 14, Week 30, Week 50
Maintenance Phase: Mayo PRO-2 Score
Time course of Mayo PRO-2 score until Week 50. Mayo patient-reported outcome score, ie, stool frequency and rectal bleeding score each rated from 0 to 3 3 that are added up to give a total score that ranges from 0 to 6. A higher score indicates a worse outcome.
Time frame: 50 weeks
Maintenance Phase: Time to Relapse
Time to symptomatic ulcerative colitis (UC) relapse
Time frame: 50 weeks
Maintenance Phase: Proportion of Patients Without Relapse
Proportion of patients without symptomatic UC relapse until Week 50
Time frame: 50 weeks
Maintenance Phase: fCP
Timecourse of biomarker fCP in stool samples
Time frame: 50 weeks
Maintenance Phase: CRP
Timecourse of biomarker CRP in blood samples
Time frame: 50 weeks
Maintenance Phase: Proportion of Patients With Endoscopic Healing
Proportion of patients with endoscopic healing (Modified Mayo endoscopy subscore of 0 or 1) at Week 50 of maintenance phase
Time frame: 50 weeks
Maintenance Phase: Proportion of Patients With Microscopic Healing
Proportion of patients with microscopic healing (Geboes score of =\< 3.1) at Week 50 of maintenance phase
Time frame: 50 weeks
Maintenance Phase: Corticosteroid-free Remission
Corticosteroid-free clinical remission (clinical remission and no receipt of systemic or local corticosteroids) at Week 50 in patients receiving corticosteroids at Baseline
Time frame: 50 weeks
Open-label Phase: Symptom Control
Proportion of patients with symptom control
Time frame: up to 4 years
Open-label Phase: fCP
Timecourse of biomarker fCP in stool samples. Visits were scheduled every 4 weeks (+/-7 days) until 50 weeks of total study participation (ie induction + extended induction, if applicable, maintenance + open-label part) and every 10 weeks (+/-7 days) thereafter. The visit schedule in the OLE after 50 weeks of overall study treatment was changed from a 10-week schedule to a 24 week (+/-14 days) schedule after Protocol Version 6.0 came into force. Because the study was terminated early, EoT varied between patients depending on when patients entered the study and the time a patient participated in the induction and maintenance phases before switching to the OLE.
Time frame: Baseline, Week 4 OLE, Week 8 OLE, EoT up to 4 years (variable)
Open-label Phase: CRP
Timecourse of biomarker CRP in blood samples. Visits were scheduled every 4 weeks (+/-7 days) until 50 weeks of total study participation (ie induction + extended induction, if applicable, maintenance + open-label part) and every 10 weeks (+/-7 days) thereafter. The visit schedule in the OLE after 50 weeks of overall study treatment was changed from a 10-week schedule to a 24 week (+/-14 days) schedule after Protocol Version 6.0 came into force. Because the study was terminated early, EoT varied between patients depending on when patients entered the study and the time a patient participated in the induction and maintenance phases before switching to the OLE.
Time frame: Baseline, Week 4 OLE, Week 8 OLE, Week 10 OLE, Week 12 OLE, Week 16 OLE, Week 20 OLE, Week 24 OLE, Week 28 OLE, Week 32 or 38 OLE (depending if entry was after extended induction phase), EoT up to 4 years (variable)
The study had 3 phases, induction, maintenance and open-label. Patients who achieved symptomatic remission at Week 10 or 22 (extended) of induction phase (IP) could proceed to maintenance phase (MP). Patients who were treated for at least 6 weeks in the induction phase and fulfilled further eligibility criteria could proceed into the open label treatment extension phase (OLE).
| Milestone | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-383 (Maintenance Phase) | Placebo (Maintenance Phase) | 30 mg IMU-838 (Open-label Phase) |
|---|---|---|---|---|---|---|---|---|
| Started | 67 | 67 | 66 | 63 | 0 | 0 | 0 | 0 |
| Completed | 53 | 48 | 50 | 52 | 0 | 0 | 0 | 0 |
| Not completed | 14 | 19 | 16 | 11 | 0 | 0 | 0 | 0 |
| Milestone | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-383 (Maintenance Phase) | Placebo (Maintenance Phase) | 30 mg IMU-838 (Open-label Phase) |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 45 | 40 | 27 | 0 |
| Completed | 0 | 0 | 0 | 0 | 35 | 29 | 21 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 10 | 11 | 6 | 0 |
| Milestone | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-383 (Maintenance Phase) | Placebo (Maintenance Phase) | 30 mg IMU-838 (Open-label Phase) |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 190 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 190 |
Composite endpoint: Proportion of patients with both, symptomatic remission (Mayo rectal bleeding subscore = 0, and Mayo stool frequency subscore of 0 or 1) and endoscopic healing (Modified Mayo endoscopy subscore of 0 or 1) at Week 10. All patients who were randomized to 30 mg/day and 45 mg/day were used for the assessment of the primary efficacy endpoint
| Participants | Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) | Placebo (Induction Phase) |
|---|---|---|
| Induction Phase: Symptomatic Remission and Endoscopic Healing at Week 10 | 16 | 8 |
Proportion of patients with both symptomatic remission and endoscopic healing at Week 10 (all individual IMU-838 doses were compared with one another and to placebo)
| Participants | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) |
|---|---|---|---|---|
| Induction Phase: Symptomatic Remission and Endoscopic Healing at Different Doses at Week 10 | 10 | 7 | 9 | 8 |
Proportion of patients achieving symptomatic remission (Mayo rectal bleeding subscore = 0, and Mayo stool frequency subscore of 0 or 1) during the induction phase
| Participants | Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) |
|---|---|---|---|---|---|
| Induction Phase: Symptomatic Remission | 56 | 28 | 38 | 25 | 31 |
Time to achieving symptomatic remission (Mayo rectal bleeding subscore = 0 and Mayo stool frequency subscore of 0 or 1) within the extended induction phase
| days | Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) |
|---|---|---|---|---|---|
| Induction Phase: Time to Achieving Symptomatic Remission | 108.8 ± 5.5 | 119.6 ± 7.1 | 98 ± 7.7 | 115.9 ± 7.4 | 101.9 ± 8.1 |
Proportion of patients with clinical response (decrease from Baseline in the full Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1) at Week 10
| Participants | Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) |
|---|---|---|---|---|---|
| Induction Phase: Proportion of Patients With Clinical Response | 50 | 27 | 31 | 23 | 27 |
Proportion of patients with endoscopic healing (Modified Mayo endoscopy subscore of 0 or 1) at Week 10
| Participants | Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) |
|---|---|---|---|---|---|
| Induction Phase: Proportion of Patients With Endoscopic Healing | 28 | 12 | 18 | 14 | 14 |
Proportion of patients with symptomatic response (≥1-point decrease from Baseline in Mayo PRO-2 score) during the induction phase (including extended induction phase)
| Participants | Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) |
|---|---|---|---|---|---|
| Induction Phase: Proportion of Patients With Symptomatic Response | 101 | 49 | 55 | 52 | 49 |
Change in full Mayo Score from Baseline to Week 10. The full Mayo score is composed of 4 categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) each rated from 0 to 3 that are added up to give a total score that ranges from 0 to 12. A higher score indicates a worse outcome.
| score on a scale | Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) |
|---|---|---|---|---|---|
| Baseline | 9.1 ± 1.4 | 9.1 ± 1.4 | 9.0 ± 1.6 | 9.1 ± 1.4 | 9.1 ± 1.4 |
| Change from Baseline to Week 10 | -2.6 ± 2.7 | -2.3 ± 2.7 | -3.0 ± 2.6 | -2.5 ± 2.7 | -2.8 ± 2.7 |
Change in partial mayo score over 10 or 22 weeks. The partial Mayo score includes only the non-invasive Mayo subscores, ie, stool frequency, rectal bleeding, and physician's global assessment (each rated from 0 to 3 that are added up to give a total score that ranges from 0 to 9). A higher score indicates a worse outcome.
| score on a scale | Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) |
|---|---|---|---|---|---|
| Baseline (all patients) | 6.6 ± 1.2 | 6.5 ± 1.1 | 6.4 ± 1.4 | 6.5 ± 1.2 | 6.6 ± 1.2 |
| Change from Baseline to Week 10 (all patients) | -2.2 ± 2.2 | -1.9 ± 2.2 | -2.4 ± 2.2 | -1.9 ± 2.0 | -2.4 ± 2.3 |
| Baseline (only patients who entered extended induction phase) | 6.6 ± 1.2 | 6.5 ± 1.0 | 6.6 ± 1.3 | 6.6 ± 1.2 | 6.7 ± 1.2 |
| Change from Baseline to Week 22 (only patients who entered extended induction phase) | -3.5 ± 2.1 | -3.6 ± 2.2 | -3.4 ± 2.3 | -3.7 ± 2.2 | -3.3 ± 2.0 |
Change in PRO-2 Mayo score over 10 or 22 weeks. Mayo PRO-2 score, ie, stool frequency and rectal bleeding score each rated from 0 to 3 that are added up to give a total score that ranges from 0 to 6. A higher score indicates a worse outcome.
| score on a scale | Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) |
|---|---|---|---|---|---|
| Baseline (all patients) | 4.3 ± 1.0 | 4.3 ± 0.9 | 4.1 ± 1.2 | 4.3 ± 1.0 | 4.3 ± 1.0 |
| Change from Baseline to Week 10 (all patients) | -1.6 ± 1.7 | -1.4 ± 1.7 | -1.7 ± 1.6 | -1.4 ± 1.6 | -1.8 ± 1.7 |
| Baseline (only patients who entered extended induction phase) | 4.3 ± 1.0 | 4.3 ± 0.8 | 4.2 ± 1.1 | 4.3 ± 1.1 | 4.3 ± 1.0 |
| Change from Baseline to Week 22 (only patients who entered extended induction phase) | -2.5 ± 1.6 | -2.6 ± 1.6 | -2.4 ± 1.8 | -2.7 ± 1.6 | -2.3 ± 1.6 |
Time course of biomarker fCP in stool samples during extended induction phase
| mg/kg | Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) |
|---|---|---|---|---|---|
| Day 0 (all patients) | 799.0 (9 to 10437) | 899.0 (39 to 5323) | 697.0 (3 to 4064) | 711.5 (55 to 10437) | 992.0 (9 to 8310) |
| Week 10 (all patients | 290.0 (13 to 6731) | 405.0 (9 to 17819) | 384.0 (3 to 19955) | 301.5 (13 to 5269) | 265.0 (17 to 6731) |
| Day 0 (Only patients who entered extended induction phase) | 616.5 (9 to 10437) | 1039.0 (46 to 5323) | 603.0 (60 to 2536) | 547.0 (115 to 10437) | 856.5 (9 to 8310) |
| Week 22 (Only patients who entered extended induction phase) | 332.0 (6 to 6699) | 387.0 (38 to 4183) | 353.0 (20 to 1515) | 314.0 (6 to 1124) | 576.0 (16 to 6699) |
Time course of biomarker CRP in blood samples during extended induction phase
| mg/L | Combined IMU-838 (30 or 45 mg IMU-838, Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) |
|---|---|---|---|---|---|
| Day 0 (all patients) | 3.50 (0.3 to 122.3) | 3.2 (0.3 to 81.1) | 5.30 (0.3 to 79.8) | 3.70 (0.3 to 122.3) | 3.50 (0.3 to 80.0) |
| Week 10 (all patients) | 3.40 (0.3 to 33.9) | 1.85 (0.3 to 50.8) | 4.00 (0.3 to 46.0) | 3.50 (0.3 to 26.3) | 2.75 (0.3 to 33.9) |
| Day 0 (Only patients who entered extended induction phase) | 3.65 (0.3 to 113.8) | 2.40 (0.3 to 78.6) | 5.55 (0.3 to 61.4) | 3.05 (0.3 to 113.8) | 7.85 (0.3 to 80.0) |
| Week 22 (Only patients who entered extended induction phase) | 2.70 (0.3 to 23.7) | 1.25 (0.3 to 69.9) | 2.80 (0.3 to 17.8) | 2.00 (0.3 to 13.0) | 2.75 (0.3 to 23.7) |
Incidence and Severity of AEs during the induction and maintenance phases
| Participants | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|---|---|---|---|
| Any TEAE | 28 | 30 | 30 | 23 | 16 | 16 | 12 |
| Any mild TEAE | 23 | 21 | 24 | 15 | 11 | 12 | 8 |
| Any moderate TEAE | 7 | 10 | 11 | 13 | 5 | 7 | 4 |
| Any severe TEAE | 2 | 3 | 2 | 0 | 2 | 2 | 0 |
The emergence of any clinically significant findings compared to screening captured during the induction and maintenance phases
| Participants | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenace Phase) | 30 mg IMU-383 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|---|---|---|---|
| Safety: Number of Participants With Clinically Significant Findings During Physical Examination | 0 | 3 | 4 | 0 | 2 | 1 | 2 |
Changes in body weight during the induction and maintenance phases
| kg | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|---|---|---|---|
| Induction phase - Day 0 | 73.881 ± 19.479 | 72.436 ± 15.348 | 73.959 ± 13.915 | 70.141 ± 15.754 | — | — | — |
| Induction phase - Week 10 | 73.747 ± 20.030 | 71.457 ± 14.522 | 75.094 ± 14.148 | 71.437 ± 15.998 | — | — | — |
| Induction phase - Week 22 | 70.310 ± 13.640 | 74.689 ± 15.143 | 75.188 ± 18.202 | 69.635 ± 14.425 | — | — | — |
| Maintenance phase - Baseline | — | — | — | — | 74.431 ± 13.081 | 70.490 ± 16.480 | 72.441 ± 13.259 |
| Maintenance phase - Week 50 | — | — | — | — | 75.743 ± 13.452 | 73.986 ± 18.069 | 70.310 ± 11.458 |
Changes in blood pressure (mm Hg) during the induction and maintenance phases
| mmHg | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|---|---|---|---|
| Induction phase - Day 0 (systolic blood pressure) | 123.2 ± 14.2 | 125.1 ± 12.8 | 123.2 ± 11.4 | 121.9 ± 11.8 | — | — | — |
| Induction phase - Week 10 (systolic blood pressure) | 123.1 ± 11.4 | 123.8 ± 13.2 | 121.7 ± 9.7 | 122.0 ± 12.8 | — | — | — |
| Induction phase - Week 22 (systolic blood pressure) | 118.3 ± 10.2 | 126.7 ± 12.3 | 119.8 ± 6.6 | 121.8 ± 12.3 | — | — | — |
| Induction phase - Day 0 (diastolic blood pressure) | 76.2 ± 10.8 | 78.1 ± 10.3 | 79.5 ± 9.4 | 74.9 ± 8.2 | — | — | — |
| Induction phase - Week 10 (diastolic blood pressure) | 76.1 ± 9.1 | 79.5 ± 9.2 | 77.3 ± 7.9 | 75.5 ± 7.9 | — | — | — |
| Induction phase - Week 22 (diastolic blood pressure) | 72.0 ± 7.6 | 77.6 ± 7.4 | 75.4 ± 6.5 | 74.2 ± 9.8 | — | — | — |
| Maintenance phase - baseline (systolic blood pressure) | — | — | — | — | 121.3 ± 10.6 | 123.7 ± 12.2 | 124.1 ± 13.0 |
| Maintenance phase - Week 50 (systolic blood pressure) | — | — | — | — | 122.0 ± 13.0 | 125.3 ± 14.3 | 122.6 ± 9.2 |
| Maintenance phase - baseline (diastolic blood pressure) | — | — | — | — | 75.2 ± 8.7 | 76.5 ± 9.5 | 75.1 ± 8.8 |
| Maintenance phase - Week 50 (diastolic blood pressure | — | — | — | — | 76.5 ± 9.9 | 77.1 ± 9.0 | 74.7 ± 6.4 |
Changes in heart rate (beats per minute) during the induction and maintenance phases
| beats per minute | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|---|---|---|---|
| Induction phase - Day 0 | 74.7 ± 13.6 | 77.4 ± 12.3 | 73.6 ± 8.9 | 73.5 ± 9.0 | — | — | — |
| Induction phase - Week 10 | 76.1 ± 13.9 | 74.1 ± 10.4 | 73.6 ± 9.0 | 73.9 ± 10.8 | — | — | — |
| Induction phase - Week 22 | 69.6 ± 13.0 | 71.9 ± 9.1 | 71.6 ± 6.2 | 70.8 ± 7.1 | — | — | — |
| Maintenance phase -Baseline | — | — | — | — | 73.0 ± 9.2 | 73.4 ± 7.5 | 72.4 ± 9.7 |
| Maintenance phase - Week 50 | — | — | — | — | 73.0 ± 8.6 | 73.2 ± 6.5 | 75.4 ± 10.7 |
Number of patients with clinically significant changes in ECG
| Participants | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|---|---|---|---|
| Safety: 12-lead Electrocardiogram (ECG) | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Number of participants with abnormal hematology laboratory values (treatment-emergent adverse events \[TEAEs\] related to hematological abnormalities)
| Participants | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|---|---|---|---|
| Anemia | 3 | 6 | 4 | 3 | 1 | 2 | 2 |
| Leukopenia | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Neutropenia | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Thrombocytosis | 0 | 1 | 0 | 1 | 0 | 0 | 1 |
| Hemoglobin decreased | 0 | 2 | 9 | 0 | 1 | 0 | 0 |
| Platelet count increased | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Leukocytosis | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Microcytic anemia | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Neutrophil count increased | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| White blood cell count increased | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Number of participants with abnormal blood chemistry laboratory values (TEAES related to clinical chemistry abnormalities)
| Participants | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-383 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|---|---|---|---|
| Alanine transferase increased | 2 | 0 | 0 | 1 | 0 | 0 | 0 |
| Amylase increased | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Aspartate aminotransferase increased | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Blood bilirubin increased | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Blood bilirubin unconjugated increased | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Blood calcium decreased | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Blood cholesterol increased | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Blood creatinine increased | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Blood creatine phosphokinase MB increased | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Blood creatine phosphokinase increased | 1 | 2 | 0 | 0 | 0 | 0 | 1 |
| Blood potassium increased | 1 | 0 | 1 | 1 | 0 | 0 | 0 |
| Blood triglycerides increased | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| C-reactive protein increased | 0 | 2 | 1 | 0 | 0 | 0 | 0 |
| Fecal calprotectin increased | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Gamma-glutamyltransferase increased | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Hepatic enzyme increased | 0 | 0 | 1 | 1 | 0 | 0 | 1 |
| Hyperbilirubinemia | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Hyperkalemia | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Hyperlipasemia | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Hypertriglyceridemia | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Hyperuricemia | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Hypokalemia | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypophosphatasemia | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Liver function test abnormal | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Lipase increased | 0 | 0 | 0 | 0 | 1 | 1 | 1 |
Number of participants with clinically significant abnormal coagulation laboratory values
| Participants | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) |
|---|---|---|---|---|
| Safety: Coagulation | 0 | 0 | 0 | 0 |
Number of participants with abnormal urinalysis laboratory values (TEAEs related to urinalysis)
| Participants | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|---|---|---|---|
| Blood urine present | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Creatinine urine increased | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Crystalluria | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Hematuria | 0 | 0 | 5 | 1 | 0 | 2 | 0 |
| Hemorrhage urinary tract | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Hyperoxaluria | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Hyperuricosuria | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Ketonuria | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Micturition urgency | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Proteinuria | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Red blood cells urine positive | 0 | 1 | 1 | 0 | 0 | 0 | 1 |
| Renal colic | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Renal Cyst | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Micro ribonucleic acid-122 (miR-122) expression (before first dose and 24 hours after first dose - foldchange of normalized expression values )
| fold change | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) |
|---|---|---|---|---|
| Safety: Micro Ribonucleic Acid-122 Expression | 2.0276 ± 2.7747 | 3.5573 ± 10.8852 | 1.8842 ± 3.5346 | 2.5739 ± 5.2723 |
Measurement of pre-dose (trough) blood plasma levels of IMU-838 throughout the induction period
| µg/mL | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) |
|---|---|---|---|
| Day 0 | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 7.34) | 0.00 (0.00 to 0.00) |
| Day 1 | 0.30 (0.00 to 1.74) | 0.94 (0.00 to 3.75) | 1.41 (0.00 to 5.63) |
| Day 7 | 0.58 (0.00 to 2.13) | 1.71 (0.00 to 8.82) | 2.77 (0.70 to 8.29) |
| Week 2 | 0.97 (0.00 to 3.00) | 3.24 (0.00 to 8.54) | 5.23 (1.30 to 11.0) |
| Week 10 | 1.17 (0.00 to 3.43) | 3.32 (0.00 to 9.32) | 5.03 (0.93 to 11.80) |
Measurement of post-dose blood plasma levels of IMU-838 at Week 2
| µg/mL | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) |
|---|---|---|---|
| PK: IMU-838 Plasma Level | 2.30 (0.00 to 4.23) | 6.05 (0.00 to 12.40) | 10.70 (1.68 to 23.40) |
Single-dose PK measurement of AUC0-24h in a subset of patients in the open-label phase
No measurements were reported for this outcome.
Single-dose PK measurement of AUC0-t in a subset of patients in the open-label phase
No measurements were reported for this outcome.
Single-dose PK measurement of AUC0-inf in a subset of patients in the open-label phase
No measurements were reported for this outcome.
Single-dose PK measurement of Cmax in a subset of patients in the open-label phase
No measurements were reported for this outcome.
Single-dose PK measurement of Tmax in a subset of patients in the open-label phase
No measurements were reported for this outcome.
Proportion of patients in symptomatic remission (Mayo rectal bleeding subscore = 0, and Mayo stool frequency subscore of 0 or 1) by visit up to Week 50 in maintenance phase
| Participants | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|
| Week 14 | 16 | 14 | 7 |
| Week 30 | 33 | 23 | 19 |
| Week 50 | 27 | 24 | 16 |
Time course of Mayo PRO-2 score until Week 50. Mayo patient-reported outcome score, ie, stool frequency and rectal bleeding score each rated from 0 to 3 3 that are added up to give a total score that ranges from 0 to 6. A higher score indicates a worse outcome.
| score on a scale | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|
| Maintenance phase Baseline | 0.8 ± 0.5 | 0.9 ± 0.8 | 0.7 ± 0.5 |
| Change from Baseline to Week 50 | 0.1 ± 0.9 | 0.2 ± 1.1 | 0.4 ± 0.9 |
Time to symptomatic ulcerative colitis (UC) relapse
| days | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|
| Maintenance Phase: Time to Relapse | 231.7 ± 10 | 221.9 ± 16.2 | 186.6 ± 10.2 |
Proportion of patients without symptomatic UC relapse until Week 50
| Participants | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|
| Maintenance Phase: Proportion of Patients Without Relapse | 32 | 24 | 18 |
Timecourse of biomarker fCP in stool samples
| mg/kg | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|
| Maintenance phase Baseline | 256.5 (3 to 1948) | 207.0 (3 to 16359) | 335.0 (9 to 4183) |
| Week 14 | 99.0 (16 to 611) | 145.0 (12 to 2386) | 353.0 (19 to 2529) |
| Week 30 | 149.0 (3 to 3169) | 217.0 (22 to 2431) | 210.0 (2 to 1694) |
| Week 50 | 181.0 (11 to 1931) | 147.0 (27 to 5777) | 364.0 (18 to 1617) |
Timecourse of biomarker CRP in blood samples
| mg/L | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|
| Maintenance phase Baseline | 1.30 (0.3 to 105.7) | 2.50 (0.3 to 38.2) | 1.10 (0.3 to 5.2) |
| Week 14 | 1.10 (0.3 to 19.2) | 1.50 (0.3 to 23.4) | 1.90 (0.3 to 7.6) |
| Week 30 | 1.30 (0.3 to 48.3) | 2.05 (0.3 to 172.3) | 1.00 (0.3 to 21.0) |
| Week 50 | 1.10 (0.3 to 12.2) | 3.60 (0.3 to 56.0) | 1.95 (0.3 to 18.6) |
Proportion of patients with endoscopic healing (Modified Mayo endoscopy subscore of 0 or 1) at Week 50 of maintenance phase
| Participants | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|
| Maintenance Phase: Proportion of Patients With Endoscopic Healing | 15 | 19 | 6 |
Proportion of patients with microscopic healing (Geboes score of =\< 3.1) at Week 50 of maintenance phase
| Participants | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|
| Maintenance Phase: Proportion of Patients With Microscopic Healing | 25 | 20 | 12 |
Corticosteroid-free clinical remission (clinical remission and no receipt of systemic or local corticosteroids) at Week 50 in patients receiving corticosteroids at Baseline
| Participants | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) |
|---|---|---|---|
| Maintenance Phase: Corticosteroid-free Remission | 10 | 16 | 5 |
Proportion of patients with symptom control
| Participants | 30 mg IMU-838 (Open-label Phase) |
|---|---|
| Open-label Phase: Symptom Control | 55 |
Timecourse of biomarker fCP in stool samples. Visits were scheduled every 4 weeks (+/-7 days) until 50 weeks of total study participation (ie induction + extended induction, if applicable, maintenance + open-label part) and every 10 weeks (+/-7 days) thereafter. The visit schedule in the OLE after 50 weeks of overall study treatment was changed from a 10-week schedule to a 24 week (+/-14 days) schedule after Protocol Version 6.0 came into force. Because the study was terminated early, EoT varied between patients depending on when patients entered the study and the time a patient participated in the induction and maintenance phases before switching to the OLE.
| mg/kg | 30 mg IMU-838 (Open-label Phase) |
|---|---|
| Entry in OLE after (extended) induction phase - Baseline | 542.0 (6 to 19955) |
| Entry in OLE after (extended) induction phase - Visit 1 (Week 4 OLE) | 557.0 (98 to 4774) |
| Entry in OLE after (extended) induction phase - Visit 2 (Week 8 OLE) | 467.0 (55 to 2271) |
| Entry in OLE after (extended) induction phase - end of treatment (up to 4 years, variable) | 234.0 (5 to 9906) |
| Entry in OLE after maintenance phase - Baseline | 221.0 (8 to 5777) |
| Entry in OLE after maintenance phase - end of treatment (up to 4 years, variable) | 168.0 (3 to 5256) |
Timecourse of biomarker CRP in blood samples. Visits were scheduled every 4 weeks (+/-7 days) until 50 weeks of total study participation (ie induction + extended induction, if applicable, maintenance + open-label part) and every 10 weeks (+/-7 days) thereafter. The visit schedule in the OLE after 50 weeks of overall study treatment was changed from a 10-week schedule to a 24 week (+/-14 days) schedule after Protocol Version 6.0 came into force. Because the study was terminated early, EoT varied between patients depending on when patients entered the study and the time a patient participated in the induction and maintenance phases before switching to the OLE.
| mg/L | 30 mg IMU-838 (Open-label Phase) |
|---|---|
| Entry in OLE after (extended) induction phase - Baseline | 5.20 (0.3 to 69.9) |
| Entry in OLE after (extended) induction phase - Visit 1 (Week 4 OLE) | 3.30 (0.3 to 41.8) |
| Entry in OLE after (extended) induction phase - Visit 2 (Week 8 OLE) | 2.30 (0.3 to 71.9) |
| Entry in OLE after (extended) induction phase - Visit 3 (Week 12 OLE) | 2.40 (0.3 to 37.3) |
| Entry in OLE after (extended) induction phase - Visit 4 (Week 16 OLE) | 2.60 (0.3 to 178.9) |
| Entry in OLE after (extended) induction phase - Visit 5 (Week 20 OLE) | 3.60 (0.3 to 46.1) |
| Entry in OLE after (extended) induction phase - Visit 6 (Week 24 OLE) | 3.40 (0.3 to 26.0) |
| Entry in OLE after (extended) induction phase - Visit 7 (Week 28 OLE) | 2.80 (0.3 to 39.5) |
| Entry in OLE after (extended) induction phase - Visit 8 (Week 32 or 38 OLE) | 2.20 (0.3 to 49.9) |
| Entry in OLE after (extended) induction phase - end of treatment (up to 4 years, variable) | 2.45 (0.3 to 46.5) |
| Entry in OLE after maintenance phase - Baseline | 1.90 (0.3 to 56.0) |
| Entry in OLE after maintenance phase - Visit 1 (Week 10 OLE) | 1.55 (0.3 to 79.8) |
| Entry in OLE after maintenance phase - Visit 2 (Week 20 OLE) | 1.25 (0.3 to 16.3) |
Collected over Adverse events were collected during each study period: induction phase up to 22 weeks, maintenance phase up to 50 weeks, open-label phase up to 4 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 10 mg IMU-838 (Induction Phase) | 0/67 (0%) | 2/67 (3%) | 8/67 (11.9%) |
| 30 mg IMU-838 (Induction Phase) | 0/67 (0%) | 5/67 (7.5%) | 7/67 (10.4%) |
| 45 mg IMU-838 (Induction Phase) | 0/66 (0%) | 5/66 (7.6%) | 12/66 (18.2%) |
| Placebo (Induction Phase) | 0/63 (0%) | 0/63 (0%) | 13/63 (20.6%) |
| 10 mg IMU-838 (Maintenance Phase) | 0/45 (0%) | 3/45 (6.7%) | 7/45 (15.6%) |
| 30 mg IMU-838 (Maintenance Phase) | 0/40 (0%) | 2/40 (5%) | 6/40 (15%) |
| Placebo (Maintenance Phase) | 0/27 (0%) | 1/27 (3.7%) | 2/27 (7.4%) |
| 30 mg IMU-838 (Open-label Phase) | 0/190 (0%) | 14/190 (7.4%) | 24/190 (12.6%) |
| Event | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) | 30 mg IMU-838 (Open-label Phase) |
|---|---|---|---|---|---|---|---|---|
| Tubulointerstitial nephritisRenal and urinary disorders | 0/67 | 0/67 | 0/66 | 0/63 | 0/45 | 0/40 | 1/27 | 0/190 |
| AnaemiaBlood and lymphatic system disorders | 1/67 | 1/67 | 1/66 | 0/63 | 0/45 | 1/40 | 0/27 | 0/190 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/67 | 0/67 | 0/66 | 0/63 | 0/45 | 1/40 | 0/27 | 0/190 |
| CholecystitisHepatobiliary disorders | 0/67 | 0/67 | 0/66 | 0/63 | 1/45 | 0/40 | 0/27 | 0/190 |
| Clostridium difficile infectionInfections and infestations | 0/67 | 0/67 | 0/66 | 0/63 | 1/45 | 0/40 | 0/27 | 0/190 |
| Acute coronary syndromeCardiac disorders | 0/67 | 0/67 | 0/66 | 0/63 | 1/45 | 0/40 | 0/27 | 0/190 |
| Diarrhea hemorrhagicGastrointestinal disorders | 0/67 | 1/67 | 0/66 | 0/63 | 0/45 | 0/40 | 0/27 | 3/190 |
| Large intestine perforationGastrointestinal disorders | 0/67 | 0/67 | 1/66 | 0/63 | 0/45 | 0/40 | 0/27 | 0/190 |
| VolvulusGastrointestinal disorders | 0/67 | 0/67 | 1/66 | 0/63 | 0/45 | 0/40 | 0/27 | 0/190 |
| Colon gangreneInfections and infestations | 0/67 | 0/67 | 1/66 | 0/63 | 0/45 | 0/40 | 0/27 | 0/190 |
| Event | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase) | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) | 30 mg IMU-838 (Open-label Phase) |
|---|---|---|---|---|---|---|---|---|
| COVID-19Infections and infestations | 2/67 | 1/67 | 2/66 | 2/63 | 5/45 | 1/40 | 0/27 | 14/190 |
| HaematuriaRenal and urinary disorders | 0/67 | 0/67 | 5/66 | 1/63 | 0/45 | 2/40 | 0/27 | 2/190 |
| AnaemiaBlood and lymphatic system disorders | 2/67 | 5/67 | 3/66 | 3/63 | 1/45 | 1/40 | 2/27 | 5/190 |
| HeadacheNervous system disorders | 3/67 | 1/67 | 1/66 | 4/63 | 0/45 | 1/40 | 0/27 | 5/190 |
| Urinary tract infectionInfections and infestations | 0/67 | 1/67 | 1/66 | 1/63 | 1/45 | 2/40 | 0/27 | 3/190 |
| VomitingGastrointestinal disorders | 1/67 | 0/67 | 0/66 | 3/63 | 0/45 | 0/40 | 0/27 | 1/190 |
In the IP, one patient received erroneously 30 mg IMU-838 instead of placebo and was included in the 30 mg IMU-838 group for the safety analysis set (SAF), as in participant flow, but in the placebo group for the full analysis set (FAS). Demographics and baseline characteristics were analyzed for the FAS. Not all participants who completed or discontinued the IP continued to the MP or OLE. Patients were re-randomized at the start of MP (except the placebo group).
| Age, Continuous(years) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) | 30 mg IMU-838 (Open-label Phase) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Induction Phase | 40.0 (19 to 73) | 41.0 (21 to 77) | 40.5 (21 to 76) | 38.5 (18 to 73) | — | — | — | — | 40.0 (18 to 77) |
| Maintenance phase | — | — | — | — | 37.0 (19 to 76) | 39.5 (22 to 77) | 38.0 (20 to 73) | — | 38.0 (19 to 77) |
| Open-label phase | — | — | — | — | — | — | — | 39.5 (18 to 77) | 39.5 (18 to 77) |
| Sex: Female, Male(Participants) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) | 30 mg IMU-838 (Open-label Phase) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Induction phase — Female | 32 | 26 | 26 | 31 | — | — | — | — | 115 |
| Induction phase — Male | 35 | 40 | 40 | 33 | — | — | — | — | 148 |
| Maintenance phase — Female | — | — | — | — | 15 | 25 | 9 | — | 49 |
| Maintenance phase — Male | — | — | — | — | 30 | 15 | 18 | — | 63 |
| Open-label phase — Female | — | — | — | — | — | — | — | 83 | 83 |
| Open-label phase — Male | — | — | — | — | — | — | — | 107 | 107 |
| Ethnicity (NIH/OMB)(Participants) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) | 30 mg IMU-838 (Open-label Phase) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Induction phase — Hispanic or Latino | 0 | 1 | 0 | 3 | — | — | — | — | 4 |
| Induction phase — Not Hispanic or Latino | 67 | 65 | 66 | 61 | — | — | — | — | 259 |
| Induction phase — Unknown or Not Reported | 0 | 0 | 0 | 0 | — | — | — | — | 0 |
| Maintenance phase — Hispanic or Latino | — | — | — | — | 0 | 0 | 0 | — | 0 |
| Maintenance phase — Not Hispanic or Latino | — | — | — | — | 45 | 40 | 27 | — | 112 |
| Maintenance phase — Unknown or Not Reported | — | — | — | — | 0 | 0 | 0 | — | 0 |
| Open-label phase — Hispanic or Latino | — | — | — | — | — | — | — | 3 | 3 |
| Open-label phase — Not Hispanic or Latino | — | — | — | — | — | — | — | 187 | 187 |
| Open-label phase — Unknown or Not Reported | — | — | — | — | — | — | — | 0 | 0 |
| Race (NIH/OMB)(Participants) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) | 30 mg IMU-838 (Open-label Phase) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Induction phase — American Indian or Alaska Native | 0 | 0 | 0 | 0 | — | — | — | — | 0 |
| Induction phase — Asian | 1 | 0 | 1 | 0 | — | — | — | — | 2 |
| Induction phase — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | — | — | — | — | 0 |
| Induction phase — Black or African American | 2 | 0 | 0 | 0 | — | — | — | — | 2 |
| Induction phase — White | 64 | 66 | 64 | 64 | — | — | — | — | 258 |
| Induction phase — More than one race | 0 | 0 | 1 | 0 | — | — | — | — | 1 |
| Induction phase — Unknown or Not Reported | 0 | 0 | 0 | 0 | — | — | — | — | 0 |
| Maintenance phase — American Indian or Alaska Native | — | — | — | — | 0 | 0 | 0 | — | 0 |
| Maintenance phase — Asian | — | — | — | — | 0 | 0 | 0 | — | 0 |
| Maintenance phase — Native Hawaiian or Other Pacific Islander | — | — | — | — | 0 | 0 | 0 | — | 0 |
| Maintenance phase — Black or African American | — | — | — | — | 0 | 0 | 0 | — | 0 |
| Maintenance phase — White | — | — | — | — | 45 | 40 | 27 | — | 112 |
| Maintenance phase — More than one race | — | — | — | — | 0 | 0 | 0 | — | 0 |
| Maintenance phase — Unknown or Not Reported | — | — | — | — | 0 | 0 | 0 | — | 0 |
| Open-label phase — American Indian or Alaska Native | — | — | — | — | — | — | — | 0 | 0 |
| Open-label phase — Asian | — | — | — | — | — | — | — | 1 | 1 |
| Open-label phase — Native Hawaiian or Other Pacific Islander | — | — | — | — | — | — | — | 0 | 0 |
| Open-label phase — Black or African American | — | — | — | — | — | — | — | 1 | 1 |
| Open-label phase — White | — | — | — | — | — | — | — | 187 | 187 |
| Open-label phase — More than one race | — | — | — | — | — | — | — | 1 | 1 |
| Open-label phase — Unknown or Not Reported | — | — | — | — | — | — | — | 0 | 0 |
| Region of Enrollment(participants) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) | 30 mg IMU-838 (Open-label Phase) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Romania | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| United States | 5 | 3 | 1 | 3 | 0 | 0 | 0 | 8 | 12 |
| Czechia | 4 | 1 | 3 | 1 | 0 | 1 | 1 | 9 | 9 |
| Ukraine | 21 | 21 | 18 | 25 | 20 | 14 | 14 | 66 | 85 |
| United Kingdom | 4 | 2 | 0 | 4 | 1 | 0 | 2 | 9 | 10 |
| Belarus | 3 | 1 | 2 | 0 | 2 | 2 | 0 | 4 | 6 |
| Portugal | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 2 |
| Albania | 3 | 2 | 3 | 5 | 0 | 4 | 3 | 2 | 13 |
| Russia | 3 | 5 | 10 | 8 | 4 | 4 | 1 | 20 | 26 |
| Spain | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Netherlands | 1 | 0 | 2 | 1 | 0 | 0 | 0 | 2 | 4 |
| North Macedonia | 5 | 2 | 2 | 1 | 1 | 1 | 0 | 6 | 10 |
| Poland | 11 | 20 | 12 | 12 | 9 | 9 | 4 | 42 | 55 |
| Bulgaria | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 3 | 3 |
| Serbia | 5 | 4 | 5 | 2 | 4 | 4 | 0 | 11 | 16 |
| Bosnia and Herzegovina | 1 | 2 | 2 | 0 | 4 | 1 | 0 | 3 | 5 |
| Croatia | 0 | 2 | 3 | 0 | 0 | 0 | 0 | 4 | 5 |
| Duration of disease(years) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) | 30 mg IMU-838 (Open-label Phase) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 7.5 ± 7.6 | 5.8 ± 5.4 | 7.1 ± 7.4 | 5.2 ± 4.6 | — | — | — | — | 6.4 ± 6.4 |
| Current tobacco users(Participants) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) | 30 mg IMU-838 (Open-label Phase) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Induction phase | 2 | 5 | 2 | 4 | — | — | — | — | 13 |
| Maintenance phase | — | — | — | — | 1 | 0 | 0 | — | 1 |
| Open-label phase | — | — | — | — | — | — | — | 10 | 10 |
| Mayo PRO-2 Score at Basline(units on a scale) | 10 mg IMU-838 (Induction Phase) | 30 mg IMU-838 (Induction Phase) | 45 mg IMU-838 (Induction Phase) | Placebo (Induction Phase) | 10 mg IMU-838 (Maintenance Phase | 30 mg IMU-838 (Maintenance Phase) | Placebo (Maintenance Phase) | 30 mg IMU-838 (Open-label Phase) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Induction phase | 4.1 ± 1.2 | 4.3 ± 1.0 | 4.3 ± 1.0 | 4.3 ± 0.9 | — | — | — | — | 4.2 ± 1.0 |
| Maintenance phase | — | — | — | — | 0.8 ± 0.5 | 0.9 ± 0.8 | 0.7 ± 0.5 | — | 0.8 ± 0.6 |
| Open-label phase (Entry in open label after induction phase) | — | — | — | — | — | — | — | 3.9 ± 1.2 | 3.9 ± 1.2 |
| Open-label phase (Entry in open label after maintenance phase) | — | — | — | — | — | — | — | 1.6 ± 1.7 | 1.6 ± 1.7 |
Showing the first 100 of 131 sites across 19 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Mar 2018 to primary completion in Nov 2022, 56 months.
Results were first posted in Mar 2024, 1 year 3 months after primary completion.
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Studies of the drug tested here: Vidofludimus-calcium
Immunic AG