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A 12-week Dose-Ranging Trial in Patients With Moderate to Severe Plaque Psoriasis

NCT01899729 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-04-07

Study results available
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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). 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.

Conditions

Interventions

DRUG

IMO-8400 Regimen 1

IMO-8400 0.075 mg/kg q wk x 12 wk by subcutaneous injection

DRUG

IMO-8400 Regimen 2

IMO-8400 0.15 mg/kg q wk x 12 wk by subcutaneous injection

DRUG

IMO-8400 Regimen 3

IMO-8400 0.3 mg/kg q wk x 12 wk by subcutaneous injection

DRUG

Saline Placebo

Saline q wk x 12 wk by subcutaneous injection

DRUG

IMO-8400 Regimen 4

IMO-8400 0.6 mg/kg q wk x 12 wk by subcutaneous injection

Sponsors & Collaborators

  • Idera Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Koos J Burggraaf, MSc, MD, PhD · Center Human Drug Research, Leiden, Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01899729 on ClinicalTrials.gov