Status:
ACTIVE_NOT_RECRUITING
A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).
Eligibility Criteria
Inclusion
- In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study
- Subject completed PA0010 \[NCT03895203\] or PA0011 \[NCT03896581\] without meeting any withdrawal criteria
- Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
Exclusion
- Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP)
- Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator
- Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated
Key Trial Info
Start Date :
August 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2026
Estimated Enrollment :
1131 Patients enrolled
Trial Details
Trial ID
NCT04009499
Start Date
August 13 2019
End Date
May 25 2026
Last Update
January 7 2026
Active Locations (138)
Enter a location and click search to find clinical trials sorted by distance.
1
Pa0012 50017
Phoenix, Arizona, United States, 85037
2
Pa0012 50035
San Diego, California, United States, 92128
3
Pa0012 50033
Palm Harbor, Florida, United States, 34684
4
Pa0012 50037
Tampa, Florida, United States, 33613