A multicenter, open label study to assess the safety and efficacy of risankizumab for maintenance in moderate to severe plaque type psoriasis

Phase 1

• Conditions: 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: EUCTR2016-003046-87-FR
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-19
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Subjects with a history of moderate to severe chronic plaque psoriasis, who have completed preceding Study 1311.13.
2. Females of childbearing potential must have a negative urine pregnancy test result at Baseline.
If female, subject must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential practicing at least one protocol specified method of birth control (Section 5.2.4), starting at Baseline through at least 20 weeks after the last dose of study drug.
3. Subjects must have signed and dated a written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission into the study.
2. Subjects must be candidates for prolonged open label risankizumab treatment according to investigator judgment
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 1675
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 325

Exclusion Criteria

1. Premature discontinuation for any reason in the preceding study.
2. Subjects who have developed guttate, erythrodermic, pustular or drug-induced psoriasis as diagnosed by the investigator during the preceding study.

Study & Design

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