A Phase 2 interventional study of ALTB-168 in Ulcerative Colitis, sponsored by AltruBio Inc.. Terminated at 12 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by AltruBio Inc. · Phase 2, Interventional, and Treatment
Among 615 studies in Colitis, Ulcerative with a site in United States — 116 open to participants now, 167 under way, 34 of them phase 3. Colitis, Ulcerative · United States.
Among the 615 studies in Colitis, Ulcerative with a site in United States, this one is the 379th largest by enrollment of the 499 interventional ones that give a count, is one of 34 that started in 2018, is one of 146 in phase 2, and was the 291st registered.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
Browse Colitis, Ulcerative studies →116 of the 615 studies in Colitis, Ulcerative with a site in United States are open now. Recruiting first, the newest first:
Hoffmann-La Roche · Sites in United States
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Sites in United States
University of Minnesota · Sites in United States
Muhammad N Aslam, MD · Sites in United States
Vanda Pharmaceuticals · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 305 Colitis, Ulcerative studies recruiting now, 134 (44%) set no upper age limit and 134 (44%) stop at 75 or younger; 71 take children under 18; 40 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
615 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 87 · Phase 2 173 · Phase 3 132 · Phase 4 33
First in 1995; this study’s year is marked. 34 started in 2018.
This study's enrollment of 24 is below the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Median enrollment 76 across the 499 interventional studies, 198 across the 113 observational. Of the 407 that completed or were terminated, 192 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
332 of 615 have an industry lead sponsor. The 10 most frequent:
AltruBio Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
AltruBio Inc. has 3 studies filed under Colitis, Ulcerative — fewer than ten, so there is no comparison to draw.
55 of the studies in Colitis, Ulcerative with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06589986Phase 3Hoffmann-La RocheA Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis | 2027-01-30 |
| NCT06260163Phase 3Janssen Research & Development, LLCA Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | 2027-02-10 |
| NCT04624230Phase 3PfizerEvaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis | 2027-03-17 |
| NCT03006068Phase 3AbbVieA Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC) | 2027-07 |
| NCT06880744Phase 3AbbVieA Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab | 2027-08 |
Among the 615 studies in Colitis, Ulcerative with a site in United States, from their registry updates:
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To evaluate the efficacy and safety of Neihulizumab (ALTB-168) administered intravenously in patients with moderate to severe active ulcerative colitis who are refractory or intolerant to anti-Tumor Necrosis Factor α and/or anti-integrin treatments.
This is a Phase II, open label, single arm, multiple dose proof of principle study to test the efficacy and safety of Neihulizumab in patients with moderate to severe active ulcerative colitis and who has failed or are intolerant to anti-TNFα and/or anti-integrin therapy. A minimum of 30 patients and a maximum of 40 will be recruited in 1 dosing group. For efficacy evaluation, the primary endpoint is the proportion of patients with clinical response, defined as ≥ 3- point reduction in MCS, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1 at Week 12. Safety assessments will consist of evaluating physical examination, vital signs (blood pressure, heart rate, respiratory rate, body temperature and oxygen saturation), safety laboratory tests, adverse events and tolerability.
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.
Moderate-to-severe active UC, at time of screening, defined as:
Stable doses of concomitant medications, including :
Exclusion Criteria:
GI related exclusion criteria:
Short gut syndrome
General health related exclusion criteria:
History of drug abuse according to the , 5th edition (DSM-V) criteria within 12 months prior to screening or positive drug screening tests.
Infection related exclusion criteria:
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.
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
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.
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 blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
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.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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.
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.
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.
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.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask 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.
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.
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.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
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.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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.
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.
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.
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.
intravenous doses of ALTB-168
Biological: ALTB-168
monoclonal antibody
Also known as: Neihulizumab
The Proportion of Patients With Clinical Response at Week 12
The clinical response is defined as a ≥ 3-point reduction in Mayo Clinic Score, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1, The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.
Time frame: week 12
The Proportion of Patients With Clinical Response (mITT)
The proportion of patients with clinical response defined as a ≥2-point decrease in partial MCS (pMCS), and with a 1 point or greater decrease of the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1. The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.
Time frame: weeks 6,16, 20 and 26
The Proportion of Patients With Clinical Remission
The number of patients with clinical remission, defined as MCS of 2 or lower (or pMCS of 1 or lower) and no subscore higher than 1. The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.
Time frame: weeks 6,16, 20 and 26
Flexible Sigmoidoscopy Subscore Changes From Baseline
The mean (SD) observed flexible sigmoidoscopy subscore change from baseline (CFB). Baseline is defined as the last available assessment prior to the first administration of the study drug. The sigmoidoscopic improvement is defined as any decrease in Mayo Clinic Score (MCS) endoscopic subscore, at Weeks 12 and 26. MCS range is 1-3. The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.
Time frame: Baseline, week 12- and week 26 after the first treatment
The Number of Patients With Mucosal Healing
The mucosal healing is defined as an absolute subscore for endoscopy of 0 or 1 The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.
Time frame: at 12- and 26-week after the first treatment
Change of Histological Activity Grade From Baseline Using the Geboes System
The number of patients with histological activity Geboes Score ≤ 3.1 (worst of both rectum and sigmoid colon). The original Geboes grade system is from Grade 0 to Grade 5. The following are the grades: Grade 0: Architectural changes Grade 1: Chronic inflammatory infiltrate Grade 2A: Eosinophils in lamina propria Grade 2B: Neutrophils in lamina propria Grade 3: Neutrophils in epithelium Grade 4:Crypt destruction Grade 5: Erosions and ulcerations
Time frame: at 12- and 26-week after the first treatment
The Number of Patients With Histological Healing
The histological healing is defined as histological grade = 0
Time frame: at 12- and 26-week after the first treatment
Change of Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline
Number of Participants with a Clinically Significant Difference in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline, to Week 12 and Week 26. The IBDQ is a questionnaire used for an assessment of Health Related Quality of Life (HRQoL) in patients with the Inflammatory Bowel Disease (IBD). The IBDQ has a possible score range of 32 (minimum) to 224 (maximum), where a higher score indicates better HRQoL. A difference of 16 points from Baseline Assessment (Baseline Score) to Week 12, and Baseline Assessment (Baseline Score) to Week 26, is considered clinically significant. The outcome measure is assessed by comparing each patient's change in individual IBDQ score from Baseline to Week 12, and from Baseline to Week 26. Patients who achieved the 16 point difference (improvement of the IBDQ score from the baseline indicating the Clinically Significant Difference) are included as responders to the treatment.
Time frame: at 12- and 26-week after the first treatment
The Number of Patients With Inflammatory IBDQ Response
The Inflammatory Bowel Disease Questionnaire (IBDQ) has a possible score range of 32 (minimum) to 224 (maximum), where a higher score indicates better Health Related Quality of Life (HRQoL). A difference of 16 points from Baseline to Week 12 and Baseline to Week 26, is considered clinically significant. The outcome measure will be assessed by comparing each patient's change in individual IBDQ score from Baseline to Week 12, and from Baseline to Week 26, to assess whether a response was seen.
Time frame: at 12- and 26-week after the first treatment
CRP Changes From Baseline (CFB) (Exploratory)
Change in biomarkers of CRP (C-reactive protein). C-reactive protein (CRP) is a biomarker produced by your liver in response to inflammation. Normal CRP value is below 1 mg/L. 1-3 mg/L is in the "yellow zone", indicating some inflammation \>3 mg/L is in the "red zone", meaning there is significant inflammation
Time frame: Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26
Changes in Fecal Calprotectin (CFB) - Exploratory Biomarker
Faecal calprotectin changes from the baseline at Week 4, 9, 12, 16, 20, and 26 were measured. Baseline is defined as the last available assessment prior to the first administration of the study drug. Faecal calprotectin is measured as mcg/g, so the results come back as a numeric value. A level under 50 is considered to be 'normal'. A level between 50 and 100, coupled with digestive symptoms, means IBS is likely. Lower level means improvement.
Time frame: Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26
Participants were enrolled at 12 centers locate in North America and Puerto Rico from May 2018 to June 2020. It was a 24 weeks open label, single arm, multiple dose proof of principle study.
| Milestone | ALTB-168 in Patients With Refractory Ulcerative Colitis |
|---|---|
| Started | 24 |
| Number of participants who received 8 doses of altb-168 | 10 |
| Number of participants who received 10 doses of altb-168 | 14 |
| Completed | 11 |
| Not completed | 13 |
| Withdrew: Lack of efficacy | 4 |
| Withdrew: Withdrawal by subject | 7 |
| Withdrew: Adverse event | 1 |
| Withdrew: Disease relapse | 1 |
The clinical response is defined as a ≥ 3-point reduction in Mayo Clinic Score, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1, The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.
| percentage of total number of patients | Pilot Study (Amendment 1~3: 9 mg/kg; Total 8 Doses) | Main Study (Amendment 4: 9 mg/kg; Total 10 Doses) |
|---|---|---|
| The Proportion of Patients With Clinical Response at Week 12 | 22.2 (2.8 to 60) | 50 (23 to 77) |
The proportion of patients with clinical response defined as a ≥2-point decrease in partial MCS (pMCS), and with a 1 point or greater decrease of the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1. The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.
| percentage of total number of patients | Pilot Study (Amendment 1~3: 9 mg/kg; Total 8 Doses) | Main Study (Amendment 4: 9 mg/kg; Total 10 Doses) |
|---|---|---|
| Clinical Response at week 6 | 33.3 (7.5 to 70.1) | 57.1 (28.9 to 82.3) |
| Clinical Response at week 16 | 0 (0 to 0) | 64.3 (35.1 to 87.2) |
| Clinical Response at week 20 | 11.1 (0.3 to 48.2) | 64.3 (35.1 to 87.2) |
| Clinical Response at week 26 | 11.1 (0.3 to 48.2) | 35.7 (12.8 to 64.9) |
The number of patients with clinical remission, defined as MCS of 2 or lower (or pMCS of 1 or lower) and no subscore higher than 1. The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.
| percentage of total number of patients | Amendment 1~3: 9 mg/kg; Total 8 Doses | Amendment 4: 9 mg/kg; Total 10 Doses |
|---|---|---|
| Clinical response at week 6 | 11.1 (0.3 to 48.2) | 35.7 (12.8 to 64.9) |
| Clinical response at week 16 | 0 (0 to 0) | 35.7 (12.8 to 64.9) |
| Clinical response at week 20 | 0 (0 to 0) | 35.7 (12.8 to 64.9) |
| Clinical response at week 26 | 11.1 (0.3 to 48.2) | 21.4 (4.7 to 50.8) |
The mean (SD) observed flexible sigmoidoscopy subscore change from baseline (CFB). Baseline is defined as the last available assessment prior to the first administration of the study drug. The sigmoidoscopic improvement is defined as any decrease in Mayo Clinic Score (MCS) endoscopic subscore, at Weeks 12 and 26. MCS range is 1-3. The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.
| score on a scale | Amendment 1~3: 9 mg/kg; Total 8 Doses | Amendment 4: 9 mg/kg; Total 10 Doses |
|---|---|---|
| Flexible Sigmoidoscopy Score at Baseline | 2.7 ± 0.5 | 2.6 ± 0.5 |
| Flexible Sigmoidoscopy Score at week 12 CFB | -0.7 ± 1.03 | -0.6 ± 1.0 |
| Flexible Sigmoidoscopy Score at week 26 CFB | 0 ± 0 | -0.6 ± 1.27 |
The mucosal healing is defined as an absolute subscore for endoscopy of 0 or 1 The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.
| participants | Amendment 1~3: 9 mg/kg; Total 8 Doses | Amendment 4: 9 mg/kg; Total 10 Doses |
|---|---|---|
| Week 12 | 2 | 4 |
| Week 26 | 0 | 3 |
The number of patients with histological activity Geboes Score ≤ 3.1 (worst of both rectum and sigmoid colon). The original Geboes grade system is from Grade 0 to Grade 5. The following are the grades: Grade 0: Architectural changes Grade 1: Chronic inflammatory infiltrate Grade 2A: Eosinophils in lamina propria Grade 2B: Neutrophils in lamina propria Grade 3: Neutrophils in epithelium Grade 4:Crypt destruction Grade 5: Erosions and ulcerations
| participants | Amendment 1~3: 9 mg/kg; Total 8 Doses | Amendment 4: 9 mg/kg; Total 10 Doses |
|---|---|---|
| Week 12 | 0 | 2 |
| Week 26 | 1 | 4 |
The histological healing is defined as histological grade = 0
| Participants | Amendment 1~3: 9 mg/kg; Total 8 Doses | Amendment 4: 9 mg/kg; Total 10 Doses |
|---|---|---|
| Week 12 | 0 | 0 |
| Week 26 | 0 | 0 |
Number of Participants with a Clinically Significant Difference in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline, to Week 12 and Week 26. The IBDQ is a questionnaire used for an assessment of Health Related Quality of Life (HRQoL) in patients with the Inflammatory Bowel Disease (IBD). The IBDQ has a possible score range of 32 (minimum) to 224 (maximum), where a higher score indicates better HRQoL. A difference of 16 points from Baseline Assessment (Baseline Score) to Week 12, and Baseline Assessment (Baseline Score) to Week 26, is considered clinically significant. The outcome measure is assessed by comparing each patient's change in individual IBDQ score from Baseline to Week 12, and from Baseline to Week 26. Patients who achieved the 16 point difference (improvement of the IBDQ score from the baseline indicating the Clinically Significant Difference) are included as responders to the treatment.
| participants | Amendment 1~3: 9 mg/kg; Total 8 Doses | Amendment 4: 9 mg/kg; Total 10 Doses |
|---|---|---|
| Week 12 | 2 | 9 |
| Week 26 | 1 | 7 |
The Inflammatory Bowel Disease Questionnaire (IBDQ) has a possible score range of 32 (minimum) to 224 (maximum), where a higher score indicates better Health Related Quality of Life (HRQoL). A difference of 16 points from Baseline to Week 12 and Baseline to Week 26, is considered clinically significant. The outcome measure will be assessed by comparing each patient's change in individual IBDQ score from Baseline to Week 12, and from Baseline to Week 26, to assess whether a response was seen.
| participants | Amendment 1~3: 9 mg/kg; Total 8 Doses | Amendment 4: 9 mg/kg; Total 10 Doses |
|---|---|---|
| Week 12 | 2 | 9 |
| Week 26 | 1 | 7 |
Change in biomarkers of CRP (C-reactive protein). C-reactive protein (CRP) is a biomarker produced by your liver in response to inflammation. Normal CRP value is below 1 mg/L. 1-3 mg/L is in the "yellow zone", indicating some inflammation \>3 mg/L is in the "red zone", meaning there is significant inflammation
| mg/L | Amendment 1~3: 9 mg/kg; Total 8 Doses | Amendment 4: 9 mg/kg; Total 10 Doses |
|---|---|---|
| Baseline | 4.3 ± 5.32 | 11.29 ± 20.555 |
| Week 4 | 6.5 ± 17.30 | -1.93 ± 14.403 |
| Am 4 Week 9, Am 1-3 Week 8 | 6.2 ± 10.65 | -0.42 ± 18.821 |
| Week 12 | 6.0 ± 8.49 | 0.12 ± 15.605 |
| Week 16 | NA ± NA | -0.65 ± 13.450 |
| Week 20 | NA ± NA | -2.94 ± 14.161 |
| Week 26 | NA ± NA | -0.42 ± 4.079 |
Faecal calprotectin changes from the baseline at Week 4, 9, 12, 16, 20, and 26 were measured. Baseline is defined as the last available assessment prior to the first administration of the study drug. Faecal calprotectin is measured as mcg/g, so the results come back as a numeric value. A level under 50 is considered to be 'normal'. A level between 50 and 100, coupled with digestive symptoms, means IBS is likely. Lower level means improvement.
| mcg/g | Amendment 1~3: 9 mg/kg; Total 8 Doses | Amendment 4: 9 mg/kg; Total 10 Doses |
|---|---|---|
| Baseline | 682.80 ± 548.153 | 1283.49 ± 758.019 |
| Week 4 (CFB) | 113.89 ± 753.179 | -203.30 ± 704.559 |
| Week 9 (Am 4, week 8 Am 1-3) | 223.17 ± 605.971 | -384.47 ± 662.420 |
| Week 12 | 923.00 ± 997.162 | -584.17 ± 847.809 |
| Week 16 | NA ± NA | -155.01 ± 1142.984 |
| Week 20 | NA ± NA | -29.46 ± 477.150 |
| Week 26 | NA ± NA | -780.30 ± 633.292 |
Collected over 26 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ALTB-168 9mg/kg (Amendment 1-3) | 0/10 (0%) | 1/10 (10%) | 9/10 (90%) |
| ALTB-168 9mg/kg (Amendment 4) | 0/14 (0%) | 0/14 (0%) | 13/14 (92.9%) |
| Event | ALTB-168 9mg/kg (Amendment 1-3) | ALTB-168 9mg/kg (Amendment 4) |
|---|---|---|
| Ulcerative Colitis FlareGastrointestinal disorders | 1/10 | 0/14 |
| Event | ALTB-168 9mg/kg (Amendment 1-3) | ALTB-168 9mg/kg (Amendment 4) |
|---|---|---|
| HeadacheNervous system disorders | 5/10 | 5/14 |
| Abdominal PainGastrointestinal disorders | 0/10 | 3/14 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/10 | 1/14 |
| ConfusionInjury, poisoning and procedural complications | 0/10 | 2/14 |
| Fecal Calprotectin IncreasedInvestigations | 0/10 | 2/14 |
| RashSkin and subcutaneous tissue disorders | 0/10 | 2/14 |
| NasopharyngitisInfections and infestations | 0/10 | 2/14 |
| ConstipationGastrointestinal disorders | 1/10 | 0/14 |
| ChillsGeneral disorders | 1/10 | 0/14 |
| FatigueGeneral disorders | 1/10 | 0/14 |
Safety population /The mITT set was defined as all patients who were enrolled and who received at least one dose of ALTB-168 treatment.
| Age, Categorical(Participants) | ALTB-168 |
|---|---|
| Enrolled Under Amendment 1-3 — <=18 years | 0 |
| Enrolled Under Amendment 1-3 — Between 18 and 65 years | 9 |
| Enrolled Under Amendment 1-3 — >=65 years | 1 |
| Enrolled Under Amendment 4 — <=18 years | 0 |
| Enrolled Under Amendment 4 — Between 18 and 65 years | 14 |
| Enrolled Under Amendment 4 — >=65 years | 0 |
| Age, Continuous(years) | ALTB-168 |
|---|---|
| Amendment 1-3 | 37 (21 to 65) |
| Amendment 4 | 35.5 (22 to 61) |
| Sex: Female, Male(Participants) | ALTB-168 |
|---|---|
| Enrolled under Amendment 1~3 — Female | 6 |
| Enrolled under Amendment 1~3 — Male | 4 |
| Enrolled under Amendment 4 — Female | 7 |
| Enrolled under Amendment 4 — Male | 7 |
| Race/Ethnicity, Customized(Participants) | ALTB-168 |
|---|---|
| Ethnicity — Hispanic or Latino | 7 |
| Ethnicity — Not Hispanic or Latino | 15 |
| Ethnicity — Not reported | 2 |
| Region of Enrollment(participants) | ALTB-168 |
|---|---|
| United States | 24 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Apr 2020, 23 months.
Results were first posted in Jul 2023, 3 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Neihulizumab
AltruBio Inc.