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

Phase 2 Terminated 167 enrolled Celgene Corporation

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2021-08-25
Primary completion: 2023-02-21
Completion: 2023-02-21

Outcome

Missed primary endpoint

Stopped: “The study has been terminated due to Non-Safety reasons because of lack of efficacy in the short-term acute phase.”

registry analysis (superiority test); Placebo Biologic Naive vs CC-99677 60 mg Biologic Naive; p = 0.829; Stratified difference 2.4 (95% CI -18.2 to 22.7); Cochran-Mantel-Haenszel NCT04947579 ↗

registry analysis (superiority test); Placebo Biologic Naive vs CC-99677 150 mg Biologic Naive; p = 0.512; Stratified difference 7.3 (95% CI -13.8 to 27.5); Cochran-Mantel-Haenszel NCT04947579 ↗

Publications

Maksymowych WP, Yeshokumar A, Cerullo E, Lambert RGW, Sliwinska-Stanczyk P, Klimiuk P, Kepich R, Pachai C, Zhu M, Liu J, Landis J, Goti V, Greenberg S. Phase II randomised, placebo-controlled study to evaluate the efficacy and safety of an MK2 inhibitor in ankylosing spondylitis. RMD Open. 2026 May 21;12(2):e006527. doi: 10.1136/rmdopen-2025-006527.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GAMCEMETINIB	Small molecule	60 mg	Oral
Subject	GAMCEMETINIB	Small molecule	150 mg	Oral