A Study of CC-99677 in Participants With Active Ankylosing Spondylitis

• Status: Recruiting
• Trial end date: 2024-02-14
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to learn about response to CC-99677 treatment by measuring signs and symptoms of Ankylosing Spondylitis (AS), objective measures of disease activity, quality of life assessments, pharmacokinetics, safety, and tolerability over a 12-week double-blind period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene

Criteria

Inclusion Criteria:

• Diagnosis of Ankylosing Spondylitis (AS) fulfilling the modified New York criteria

• Active axial disease at Screening and Baseline defined by a Bath Ankylosing

• Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and Total Back Pain ≥ 4

• Failed prior treatment with at least 2 NSAIDs for at least 4 weeks each

• Participant has never received a biologic therapy eg, tumor necrosis factor (TNF) antagonist or monoclonal antibody [mAb] against IL-17A (biologic naive main study), or have taken more than one biologic therapy (biologic-failure substudy) for the treatment of AS

Exclusion Criteria:

• Radiographic evidence of 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 (prednisone or equivalent) > 10 mg/day systemically for ≥ 2 weeks prior to Baseline Visit