Active, Not Recruiting

Trial ID CC-99677-AS-001 | NCT04947579

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

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

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About This Trial
Key Eligibility Criteria

Summary

Phase 2
18-65

Age Range
Active, Not Recruiting

Overview

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.

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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Administration of CC-99677 150 mg QD PO

ASSIGNED INTERVENTION

Drug: CC-99677

Study Arms

Experimental: Administration of CC-99677 150 mg QD PO.

ASSIGNED INTERVENTION

Drug: CC-99677

Study Arms

Experimental: Administration of CC-99677 60mg QD PO

ASSIGNED INTERVENTION

Drug: CC-99677

Study Arms

Experimental: Administration of CC-99677 60mg QD PO.

ASSIGNED INTERVENTION

Drug: CC-99677

Study Arms

Placebo Comparator: Administration of Placebo QD PO

ASSIGNED INTERVENTION

Other: Placebo

Study Arms

Placebo Comparator: Placebo additional dose cohort

ASSIGNED INTERVENTION

Other: Placebo