Plaque PsoriasisPhase 28400-201NCT01899729
A 12-week Dose-Ranging Trial in Patients With Moderate to Severe Plaque Psoriasis
A Phase 2 study testing IMO-8400 Regimen 1, IMO-8400 Regimen 2 and IMO-8400 Regimen 3 in people with Plaque Psoriasis, run by Idera Pharmaceuticals, Inc. at 1 site in Netherlands.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- IMO-8400 Regimen 1, IMO-8400 Regimen 2 and IMO-8400 Regimen 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2013to Apr 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is age 18 to 70 years, inclusive
- Completes the informed consent procedure (see Section 15.2), including signing and dating the informed consent form
- Has moderate to severe plaque psoriasis meeting the criteria specified above
- Is willing and able to comply with the restrictions detailed above
- Female subjects must have a negative pregnancy test at screening and on Day 1 prior to start of treatment
- Female subjects of childbearing potential (see Section 8.2) and male subjects who have partners of childbearing potential must agree to use effective birth control (contraception; see Section 8.2) from Screening through the treatment period and for ninety (90) days after the last injection of study drug
Who cannot join
- Has known hypersensitivity to any oligodeoxynucleotide
- Is nursing
- Has body weight <50 kg
- Has BMI >34.9 kg/m2
- Regularly consumes >3 drinks of alcoholic beverages (beer, wine, or distilled spirits) per day
- Has a positive test for antibody to human immunodeficiency virus (HIV-1 or -2) or hepatitis C virus (HCV)
Show all 24Show fewer
- Has a positive test for hepatitis B surface antigen (HBsAg)
- Has at screening safety laboratory tests meeting one or more of the following criteria:
- hemoglobin <6.52 mmol/L (<10.5 g/dL)
- white blood cell count <4x109/L ( <4,000/mm3)
- absolute neutrophil count (ANC) <1.5x109/L (<1500/mm3)
- platelet count <100x109/L (<100,000/mm3 )
- serum creatinine >1.3x ULN;
- alanine transaminase (ALT; SGPT) >2.5x ULN
- aspartate transaminase (AST; SGOT) >2.5x ULN
- serum total bilirubin >1.4x ULN (except if consistent with Gilbert's disease: i.e., total bilirubin <103 μmol/L (6 mg/dL) and conjugated bilirubin <1.2x ULN)
- Has a history of allogeneic organ transplant (including bone marrow or stem cells)
- Has, within the past 10 years, had evidence of or required treatment for cancer (except for treated, non-invasive carcinoma of the skin or cured cervical carcinoma-in-situ)
- Has had within the past three months or is expected to have during the study period any of the following treatments:
- surgery requiring general anesthesia
- hematopoietic stimulating agents (e.g., erythropoietin, G-CSF, GM-CSF)
- another investigational drug;
- Has other significant medical conditions (chronic or active within the past 6 months), including, but not limited to: cardiac disease (e.g., unstable angina, myocardial infarction, congestive heart failure, ventricular arrhythmia); uncontrolled seizure disorder; liver disease; uncontrolled diabetes
- Has any other condition that would, in the opinion of the Investigator, potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, 12-week Dose-Ranging Trial of IMO-8400 in Patients With Moderate to Sever Plaque Psoriasis
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.
Read the detailed description
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.
- Conditions
- Plaque Psoriasis
- Being tested
- IMO-8400 Regimen 1, IMO-8400 Regimen 2, IMO-8400 Regimen 3, Saline Placebo, IMO-8400 Regimen 4
- Keywords
- plaque psoriasis, autoimmune disease, Toll like receptor
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMO-8400 Regimen 1Drug
IMO-8400 0.075 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 2Drug
IMO-8400 0.15 mg/kg q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 3Drug
IMO-8400 0.3 mg/kg q wk x 12 wk by subcutaneous injection
Saline PlaceboDrug
Saline q wk x 12 wk by subcutaneous injection
IMO-8400 Regimen 4Drug
IMO-8400 0.6 mg/kg q wk x 12 wk by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| IMO-8400 Regimen 1 | Experimental | IMO 8400 at 0.075 mg/kq q wk x 12 wks Receives: Drug: IMO-8400 Regimen 1 |
| IMO-8400 Regimen 2 | Experimental | IMO-8400 at 0.15 mg/kg q wk x 12 wks Receives: Drug: IMO-8400 Regimen 2 |
| IMO-8400 Regimen 3 | Experimental | IMO_8400 at 0.3 mg/kg q wk x 12 wks Receives: Drug: IMO-8400 Regimen 3 |
| Placebo | Placebo comparator | Saline (placebo) q wk x 12 wks Receives: Drug: Saline Placebo |
| IMO-8400 Regimen 4 | Experimental | IMO_8400 at 0.6 mg/kg q wk x 12 wks Receives: Drug: IMO-8400 Regimen 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of IMO-8400 Compared With Placebo
The number of adverse events related and not related to treatment
Measured: 19 weeks (12 weeks on treatment + 7 week follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idera Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Koos J Burggraaf, MSc, MD, PhD, Principal investigator, Center Human Drug Research, Leiden, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899729
- Sponsor's protocol ID
- 8400-201
- Other IDs
- 2013-000164-28
- Acronym
- 8400-201
- Status last verified
- Feb 2022
- First submitted
- 2 Jul 2013
- Last updated
- 7 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Balak DM, van Doorn MB, Arbeit RD, Rijneveld R, Klaassen E, Sullivan T, Brevard J, Thio HB, Prens EP, Burggraaf J, Rissmann R. IMO-8400, a toll-like receptor 7, 8, and 9 antagonist, demonstrates clinical activity in a phase 2a, randomized, placebo-controlled trial in patients with moderate-to-severe plaque psoriasis. Clin Immunol. 2017 Jan;174:63-72. doi: 10.1016/j.clim.2016.09.015. Epub 2016 Nov 20.
PubMed 27876460
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, 12-week Dose-Ranging Trial of IMO-8400 in Patients With Moderate to Sever Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01899729
- Acronym / sponsor ID
- 8400-201 / 8400-201
- Conditions
- Plaque Psoriasis
- Keywords
- plaque psoriasis, autoimmune disease, Toll like receptor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Idera Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 15 Jul 2013 (estimated)
- Results
- Posted 2 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| IMO-8400 Regimen 1 | Experimental | Drug: IMO-8400 Regimen 1IMO 8400 at 0.075 mg/kq q wk x 12 wks |
| IMO-8400 Regimen 2 | Experimental | Drug: IMO-8400 Regimen 2IMO-8400 at 0.15 mg/kg q wk x 12 wks |
| IMO-8400 Regimen 3 | Experimental | Drug: IMO-8400 Regimen 3IMO_8400 at 0.3 mg/kg q wk x 12 wks |
| Placebo | Placebo comparator | Drug: Saline PlaceboSaline (placebo) q wk x 12 wks |
| IMO-8400 Regimen 4 | Experimental | Drug: IMO-8400 Regimen 4IMO_8400 at 0.6 mg/kg q wk x 12 wks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Is age 18 to 70 years, inclusive
- Completes the informed consent procedure (see Section 15.2), including signing and dating the informed consent form
- Has moderate to severe plaque psoriasis meeting the criteria specified above
- Is willing and able to comply with the restrictions detailed above
- Female subjects must have a negative pregnancy test at screening and on Day 1 prior to start of treatment
Key exclusion criteria (24 listed)
- Has known hypersensitivity to any oligodeoxynucleotide
- Is nursing
- Has body weight <50 kg
- Has BMI >34.9 kg/m2
- Regularly consumes >3 drinks of alcoholic beverages (beer, wine, or distilled spirits) per day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMO-8400 Regimen 1IMO-8400 0.075 mg/kg q wk x 12 wk by subcutaneous injection | Drug | IMO-8400 Regimen 1 |
| IMO-8400 Regimen 2IMO-8400 0.15 mg/kg q wk x 12 wk by subcutaneous injection | Drug | IMO-8400 Regimen 2 |
| IMO-8400 Regimen 3IMO-8400 0.3 mg/kg q wk x 12 wk by subcutaneous injection | Drug | IMO-8400 Regimen 3 |
| Saline PlaceboSaline q wk x 12 wk by subcutaneous injection | Drug | Placebo |
| IMO-8400 Regimen 4IMO-8400 0.6 mg/kg q wk x 12 wk by subcutaneous injection | Drug | IMO-8400 Regimen 4 |
Primary outcome
Safety and Tolerability of IMO-8400 Compared With Placebo
Time frame: 19 weeks (12 weeks on treatment + 7 week follow up)
The number of adverse events related and not related to treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27876460Balak DM, van Doorn MB, Arbeit RD, Rijneveld R, Klaassen E, Sullivan T, Brevard J, Thio HB, Prens EP, Burggraaf J, Rissmann R. IMO-8400, a toll-like receptor 7, 8, and 9 antagonist, demonstrates clinical activity in a phase 2a, randomized, placebo-controlled trial in patients with moderate-to-severe plaque psoriasis. Clin Immunol. 2017 Jan;174:63-72. doi: 10.1016/j.clim.2016.09.015. Epub 2016 Nov 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koos J Burggraaf, MSc, MD, PhD principal investigator
Center Human Drug Research, Leiden, Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMO-8400 Regimen 1, IMO-8400 Regimen 2 and IMO-8400 Regimen 3 in people with Plaque Psoriasis, run by Idera Pharmaceuticals, Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of IMO-8400 Compared With Placebo (time frame: 19 weeks (12 weeks on treatment + 7 week follow up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01899729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.