A Phase 2 interventional study of IMO-8400 Regimen 1 and IMO-8400 Regimen 2 in Plaque Psoriasis, sponsored by Idera Pharmaceuticals, Inc.. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Idera Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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Among 30 studies in Autoimmune Diseases with a site in Netherlands — 11 open to participants now, 12 under way, 5 of them phase 3. Autoimmune Diseases · Netherlands.
Among the 30 studies in Autoimmune Diseases with a site in Netherlands, this one is the 16th largest by enrollment of the 23 interventional ones that give a count, is one of 2 that started in 2013, is one of 7 in phase 2, and was the 7th registered.
803 studies on the registry are indexed under Autoimmune Diseases; 272 are open to participants now.
Browse Autoimmune Diseases studies →11 of the 30 studies in Autoimmune Diseases with a site in Netherlands are open now. Recruiting first, the newest first:
University of Washington · Sites in Netherlands, United States
Ages 18–69
Novartis Pharmaceuticals · Sites in Netherlands, United States, Australia and 17 more countries
Ages 18+
Takeda · Sites in Netherlands, United States, Australia and 12 more countries
Ages 18+
Takeda · Sites in Netherlands, United States, Australia and 15 more countries
Ages 18+
GlaxoSmithKline · Sites in Netherlands, United States, Argentina and 15 more countries
Ages 18+
A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →
Of the 195 Autoimmune Diseases studies recruiting now, 90 (46%) set no upper age limit and 79 (41%) stop at 75 or younger; 55 take children under 18; 36 take healthy volunteers.
This study: 18 Years to 70 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.
30 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 46 is above the median of 40 across 542 interventional studies indexed under Autoimmune Diseases.
Median enrollment 109 across the 23 interventional studies, 1,500 across the 7 observational. Of the 18 that completed or were terminated, 11 (61%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 30 have an industry lead sponsor. The 10 most frequent:
Idera Pharmaceuticals, Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.
Idera Pharmaceuticals, Inc. has 1 study filed under Autoimmune Diseases — fewer than ten, so there is no comparison to draw.
1 of the studies in Autoimmune Diseases with a site in Netherlands that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925803Phase 3AstraZenecaDetermine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) | 2027-01-06 |
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Among the 30 studies in Autoimmune Diseases with a site in Netherlands, from their registry updates:
This tab as a report to print or save as PDF → With an account.
IMO 8400 is a second-generation oligonucleotide antagonist of endosomal Toll-like receptors (TLR) 7, TLR8 and TLR9. These TLR react to complexes of exogenous nucleic acids (as might be encountered during infection) and endogenous nucleic acids (as might be released during tissue damage during autoimmune disease). In vitro and in multiple animal models of autoimmune disease, IMO-8400 blocks immune activation mediated through TLR7, 8 and 9. In Phase 1 studies (Protocol 8400-001) IMO 8400 has been administered to healthy adults by SC injection at single-doses and multiple-doses (4 weeks) up to 0.6 mg/kg. All treatments were well-tolerated, with mild injection site reactions and no pattern of systemic reactions or laboratory changes.
The current study represents the first clinical trial of IMO-8400 in patients with active autoimmune disease. Moderate to severe plaque psoriasis was chosen for this 12-week proof of activity trial based on a prior 4-week study using a first generation TLR7 and 9 antagonist which demonstrated clinical improvement in this patient population.
Eligible subjects will be enrolled and randomized to receive one of the four treatments (three dose levels of IMO-8400 or Saline Placebo). Treatments will be administered once weekly by subcutaneous injections. Subjects will received treatment for 12 weeks and then be followed for an additional 6 weeks to assess the durability of the response.
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.
Exclusion Criteria:
Has at screening safety laboratory tests meeting one or more of the following criteria:
Has had within the past three months or is expected to have during the study period any of the following treatments:
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.
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.
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.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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 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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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 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.
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.
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.
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.
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.
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.
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.
IMO 8400 at 0.075 mg/kq q wk x 12 wks
Drug: IMO-8400 Regimen 1
IMO-8400 at 0.15 mg/kg q wk x 12 wks
Drug: IMO-8400 Regimen 2
IMO_8400 at 0.3 mg/kg q wk x 12 wks
Drug: IMO-8400 Regimen 3
Saline (placebo) q wk x 12 wks
Drug: Saline Placebo
IMO_8400 at 0.6 mg/kg q wk x 12 wks
Drug: IMO-8400 Regimen 4
IMO-8400 0.075 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 0.15 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 0.3 mg/kg q wk x 12 wk by subcutaneous injection
Saline q wk x 12 wk by subcutaneous injection
IMO-8400 0.6 mg/kg q wk x 12 wk by subcutaneous injection
Safety and Tolerability of IMO-8400 Compared With Placebo
The number of adverse events related and not related to treatment
Time frame: 19 weeks (12 weeks on treatment + 7 week follow up)
| Milestone | IMO-8400 Regimen 1 | IMO-8400 Regimen 2 | IMO-8400 Regimen 3 | IMO-8400 Regimen 4 | Placebo |
|---|---|---|---|---|---|
| Started | 9 | 9 | 8 | 9 | 11 |
| Completed | 7 | 7 | 6 | 9 | 9 |
| Not completed | 2 | 2 | 2 | 0 | 2 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 2 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 0 | 0 | 2 | 0 | 1 |
The number of adverse events related and not related to treatment
| adverse events | IMO-8400 Regimen 1 | IMO-8400 Regimen 2 | IMO-8400 Regimen 3 | IMO-8400 Regimen 4 | Placebo |
|---|---|---|---|---|---|
| AE Related to Treatment | 6 | 6 | 6 | 5 | 6 |
| AE Not Related to Treatment | 3 | 3 | 2 | 4 | 5 |
Collected over From first dose of study treatment to Study Day 113.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IMO-8400 Regimen 1 | 0/9 (0%) | 0/9 (0%) | 8/9 (88.9%) |
| IMO-8400 Regimen 2 | 0/9 (0%) | 0/9 (0%) | 8/9 (88.9%) |
| IMO-8400 Regimen 3 | 0/8 (0%) | 0/8 (0%) | 7/8 (87.5%) |
| IMO-8400 Regimen 4 | 0/9 (0%) | 0/9 (0%) | 7/9 (77.8%) |
| Placebo | 0/11 (0%) | 0/11 (0%) | 9/11 (81.8%) |
| Event | IMO-8400 Regimen 1 | IMO-8400 Regimen 2 | IMO-8400 Regimen 3 | IMO-8400 Regimen 4 | Placebo |
|---|---|---|---|---|---|
| HeadacheNervous system disorders | 4/9 | 3/9 | 2/8 | 4/9 | 5/11 |
| Injection site hematomaGeneral disorders | 1/9 | 2/9 | 3/8 | 1/9 | 2/11 |
| Influenza like illnessGeneral disorders | 1/9 | 3/9 | 2/8 | 1/9 | 1/11 |
| FatigueGeneral disorders | 1/9 | 3/9 | 1/8 | 1/9 | 1/11 |
| DiarrheaGastrointestinal disorders | 3/9 | 1/9 | 1/8 | 2/9 | 0/11 |
| Injection site painGeneral disorders | 2/9 | 0/9 | 0/8 | 0/9 | 1/11 |
| Injection site erythemaGeneral disorders | 2/9 | 0/9 | 0/8 | 0/9 | 0/11 |
| NauseaGastrointestinal disorders | 2/9 | 0/9 | 1/8 | 0/9 | 0/11 |
| Upper respiratory tract infectionInfections and infestations | 1/9 | 2/9 | 1/8 | 1/9 | 1/11 |
| InsomniaPsychiatric disorders | 0/9 | 2/9 | 1/8 | 0/9 | 1/11 |
Safety population
| Age, Continuous(years) | IMO-8400 Regimen 1 | IMO-8400 Regimen 2 | IMO-8400 Regimen 3 | IMO-8400 Regimen 4 | Placebo | Total |
|---|---|---|---|---|---|---|
| Median | 53 (19 to 66) | 31 (20 to 66) | 42.5 (20 to 70) | 45 (23 to 65) | 44 (25 to 66) | 44 (19 to 70) |
| Sex: Female, Male(Participants) | IMO-8400 Regimen 1 | IMO-8400 Regimen 2 | IMO-8400 Regimen 3 | IMO-8400 Regimen 4 | Placebo | Total |
|---|---|---|---|---|---|---|
| Female | 4 | 3 | 2 | 1 | 2 | 12 |
| Male | 5 | 6 | 6 | 8 | 9 | 34 |
| Race (NIH/OMB)(Participants) | IMO-8400 Regimen 1 | IMO-8400 Regimen 2 | IMO-8400 Regimen 3 | IMO-8400 Regimen 4 | Placebo | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 2 | 0 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 5 | 8 | 6 | 9 | 8 | 36 |
| More than one race | 2 | 0 | 0 | 0 | 1 | 3 |
| Unknown or Not Reported | 2 | 1 | 0 | 0 | 0 | 3 |
| Region of Enrollment(participants) | IMO-8400 Regimen 1 | IMO-8400 Regimen 2 | IMO-8400 Regimen 3 | IMO-8400 Regimen 4 | Placebo | Total |
|---|---|---|---|---|---|---|
| Netherlands | 9 | 9 | 8 | 9 | 11 | 46 |
| Body Mass Index(kg/m^2) | IMO-8400 Regimen 1 | IMO-8400 Regimen 2 | IMO-8400 Regimen 3 | IMO-8400 Regimen 4 | Placebo | Total |
|---|---|---|---|---|---|---|
| Median | 26.5 (18.0 to 31.8) | 21.2 (19.2 to 33.8) | 27.15 (25.2 to 28.6) | 27.7 (19.6 to 40.4) | 30.9 (25.3 to 36.1) | 27.2 (18.0 to 40.4) |
The record gives a start of May 2013, a primary completion of Apr 2014 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2019, 5 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bazlitoran
Idera Pharmaceuticals, Inc.