A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects with Psoriatic Arthritis

Phase 1

• Conditions: Psoriatic Arthritis; MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-001003-74-DE
• Lead Sponsor: CB Biopharma SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-20
• Last Update Posted: 11 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

- In the opinion of the Investigator, the subject is expected to benefit from participation in an Open Label Extension (OLE) study
- Subject completed PA0008 without meeting any withdrawal criteria
- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception - Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active
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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of IMP. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
- Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry.
- Subjects who meet any withdrawal criteria in PA0008. For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject’s entry into PA0009

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess the long-term safety and tolerability of bimekizumab administered over a period of up to 2 years.;Secondary Objective: Assess the long-term efficacy of bimekizumab.;<br> Primary end point(s): 1. Incidence of Treatment Emergent Adverse Events (TEAEs) during the study<br> 2. Incidence of Treatment Emergent Serious Adverse Events (SAEs) during the study<br> ;Timepoint(s) of evaluation of this end point: 1-2. From Entry Visit of PA0009 until Safety Follow-Up Visit (up to Week 120)