A Study of CC-99677 in Participants With Active Ankylosing Spondylitis (AS SpA axSpA)

  • STATUS
    Recruiting
  • End date
    Feb 14, 2024
  • participants needed
    256
  • sponsor
    Celgene
Updated on 22 March 2022
tumor necrosis factor
back pain
tumour necrosis

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.

Details
Condition Spondylitis, Ankylosing
Treatment Placebo, CC-99677
Clinical Study IdentifierNCT04947579
SponsorCelgene
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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