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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Spondylitis, Ankylosing

In brief

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 facts

Study ID

NCT04947579

Run by

Celgene

People needed

167

Starts

2021-08-25

Expected to finish

2023-02-21

Last updated by the study team

2024-05-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 021 — Gilbert, Arizona, United States
• Local Institution - 022 — Phoenix, Arizona, United States
• Local Institution - 025 — Tucson, Arizona, United States
• Local Institution - 017 — Tustin, California, United States
• Local Institution - 026 — Saint Clair Shores, Michigan, United States
• Local Institution - 028 — Cleveland, Ohio, United States
• Local Institution - 004 — Dayton, Ohio, United States
• Local Institution - 009 — Portland, Oregon, United States
• Local Institution - 003 — Duncansville, Pennsylvania, United States
• Local Institution - 005 — Jackson, Tennessee, United States
• Local Institution - 002 — Memphis, Tennessee, United States
• Local Institution - 029 — Austin, Texas, United States
• Local Institution - 006 — Colleyville, Texas, United States
• Local Institution - 019 — Fort Worth, Texas, United States
• Local Institution - 008 — Houston, Texas, United States
• Local Institution - 154 — Shanghai, Shanghai Municipality, China
• Local Institution - 151 — Guangzhou, China
• Local Institution - 152 — Hangzhou, China
• Local Institution - 153 — Huangpu District, China
• Local Institution - 150 — Wuhan, China
• Local Institution - 205 — Brno, Czechia
• Local Institution - 206 — Ostrava, Czechia
• Local Institution - 207 — Ostrava, Czechia
• Local Institution - 201 — Pardubice, Czechia
• Local Institution - 024 — Flagstaff, Arizona, United States

Full record on ClinicalTrials.gov

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