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

• Register: EUCTR
• Last refreshed on: 12 May 2014
• Main ID: EUCTR2013-000164-28-NL
• Date of registration: 20/03/2013
• Prospective Registration: Yes
• Primary sponsor: Idera Pharmaceuticals, Inc.
• Public title: A study with IMO-8400 in Patients with Moderate to Severe Psoriasis
• Scientific title: 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
• Date of first enrolment: 04/04/2013
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000164-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 5

Countries of recruitment

Netherlands

Contacts

• Name: VP, Clinical Development
• Affiliation: Idera Pharmaceuticals, Inc.

• Name: VP, Clinical Development
• Affiliation: Idera Pharmaceuticals, Inc.

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Intervention(s)

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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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 Outcome(s)

Timepoint(s) of evaluation of this end point: End of treatment (week 13)

Secondary end point(s): PASI, DLQI, PGA, BSA scores

Secondary ID(s)

8400-201

CHDR1228

Source(s) of Monetary Support

Idera Pharmaceuticals, Inc.