Extension trial assessing the safety and efficacy of BI 655066/ABBV-066/risankizumab in patients with moderate to severe chronic plaque psoriasis

Phase 1

• Conditions: Patients with moderate to severe chronic plaque psoriasis.; MedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-001687-36-DE
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-11
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

-Patients with moderate to severe chronic plaque psoriasis, who have successfully completed the preceding trial, 1311.2. Successful completion of preceding trial is defined as either of the following:
a.Completion of the entire follow up period, thus reaching EOS visit.
b.Loss of response, defined as decrease in response to - Patient must give informed consent and sign an approved consent form prior to any study procedures in accordance with GCP and local legislation

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 128
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

-Patients who experienced any drug related Serious Adverse Event in the preceding trial
-Patients who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the investigator), during the preceding trial 1311.2
-Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding of the medical examination (including vital signs and ECG), that in the opinion of the investigator, would compromise the safety of the patient or the quality of the data
-Known clinically important acute or chronic infections including hepatitis, HIV and tuberculosis (including latent tuberculosis), or a positive interferon gamma release assay (IGRA) testing for tuberculosis (if available at visit 1)
-Patients who have developed malignancy, or suspicion of active malignant disease during the preceding trial 1311.2 (except treated cutaneous squamous cell or basal cell carcinoma or carcinoma in situ of the cervix that have been adequately treated).
- Male patients (per local German protocol amendment 3)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified