A study to determine how effective and safe the drug CC-99677 is for patients with active Ankylosing Spondylitis

Phase 1

• Conditions: Ankylosing Spondylitis; MedDRA version: 20.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-004108-37-PL
• Lead Sponsor: Celgene Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

-Diagnosis of AS fulfilling the modified New York criteria
-Active axial disease defined by a BASDAI score = 4 and Total Back Pain = 4
-Failed prior treatment with at least 2 NSAIDs for at least 4 weeks each
-Subject has never received a biologic therapy for the treatment of AS, or have taken more than one biologic therapy
- Concomitant use of sulfasalazine is permitted provided it is used at a stable dose for at least 4 weeks prior to Baseline (Day 1 of study)

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 256
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Total ankylosis of the spine
-Clinically significant back pain caused by diseases other than AS
-Concurrent treatment or treatment within the 6 months prior to Baseline with cell depleting biologic agents
-Participation in any study of an investigational drug, including those for COVID-19
-History of malignancy
-Oral corticosteroids > 10 mg/day for = 2 weeks prior to Baseline Visit

Study & Design

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