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  • NCT04947579

Active, Not Recruiting

A Study of CC-99677 in Participants With Active Ankylosing Spondylitis - CC-99677-AS-001

Updated: 9 December, 2022   |   ClinicalTrials.gov

Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company

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SELECT LANGUAGE

Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18-65

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Administration of CC-99677 150 mg QD PO
Drug: CC-99677
Experimental: Administration of CC-99677 150 mg QD PO.
Drug: CC-99677
Experimental: Administration of CC-99677 60mg QD PO
Drug: CC-99677
Experimental: Administration of CC-99677 60mg QD PO.
Drug: CC-99677
Placebo Comparator: Administration of Placebo QD PO
Other: Placebo
Placebo Comparator: Placebo additional dose cohort
Other: Placebo

Key Eligibility 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

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