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A study with IMO-8400 in Patients with Moderate to Severe Psoriasis

A Randomized, Double-Blind, Placebo-Controlled, 12-week Dose-Ranging Trial of IMO-8400 in Patients with Moderate to Severe Plaque Psoriasis - IMO-8400 in Patients with Moderate to Severe Plaque Psoriasis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-000164-28-NL
Enrollment
Unknown
Registered
2013-03-20
Start date
2013-04-04
Completion date
Unknown
Last updated
2014-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Plaque Psoriasis MedDRA version: 14.1 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1 Level: LLT Classification code 10050577 Term: Psoriatic plaque System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Product Name: IMO-8400 Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: IMO-8400 Current Sponsor code: IMO-8400 Other descriptive name: OLIGONUCLEOTIDE AGONIST Concent

Sponsors

Idera Pharmaceuticals, Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients, 18-70 years, with a clinical diagnosis of moderate to severe plaque psoriasis for at least 6 months, PASI =12.0, who are candidate for systemic treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: Significant medical conditions (cardiac disease, liver disease, uncontrolled diabetes, uncontrolled seizure disorder, cancer). Positive screening test for HIV, hepatitis B or C.

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluation of safety and tolerability of different dose levels of IMO-8400 compared with placebo administered for 12 weeks;Secondary Objective: Evaluation of treatment of different dose levels of IMO-8400 compared with placebo administered for 12 weeks;Primary end point(s): Safety;Timepoint(s) of evaluation of this end point: Regularly up to 19 weeks post start treatment—

Secondary

MeasureTime frame
Secondary end point(s): PASI, DLQI, PGA, BSA scores;Timepoint(s) of evaluation of this end point: End of treatment (week 13)—

Countries

Netherlands

Contacts

Public ContactVP, Clinical Development

Idera Pharmaceuticals, Inc.

rarbeit@iderapharma.com16176795574

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 11, 2026