A Study of CC-99677 in Participants With Active Ankylosing Spondylitis
NCT ID: NCT04947579
Last Updated: 2024-05-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
167 participants
INTERVENTIONAL
2021-08-25
2023-02-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Double Blind, Placebo Controlled Study to Assess Efficacy of AIN457 in Moderate to Severe Ankylosing Spondylitis
NCT00809159
Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis
NCT01786668
16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis
NCT01358175
Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)
NCT03502616
Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
NCT03259074
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Administration of CC-99677 150 mg QD PO
49 participants will be randomized to CC-99677 150 mg in biologic naive main study
CC-99677
Oral
Administration of CC-99677 60mg QD PO
49 participants will be randomized to CC-99677 60 mg in biologic naive main study
CC-99677
Oral
Administration of Placebo QD PO
49 participants will be randomized to placebo in biologic naive main study
Placebo
Oral
Administration of CC-99677 150 mg QD PO.
20 participants will be randomized to CC-99677 150 mg in biologic-failure substudy
CC-99677
Oral
Administration of CC-99677 60mg QD PO.
20 participants will be randomized to CC-99677 60 mg in biologic-failure substudy
CC-99677
Oral
Placebo additional dose cohort
10 participants will be randomized to placebo in biologic-failure substudy
Placebo
Oral
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CC-99677
Oral
Placebo
Oral
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Celgene
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb, MD
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution - 024
Flagstaff, Arizona, United States
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 - 202
Prague, , Czechia
Local Institution - 203
Prague, , Czechia
Local Institution - 211
Prague, , Czechia
Local Institution - 204
Uherské Hradište, , Czechia
Local Institution - 900
Herne, , Germany
Local Institution - 311
Bialystok, , Poland
Local Institution - 315
Bialystok, , Poland
Local Institution - 305
Bydgoszcz, , Poland
Local Institution - 302
Bydgoszcz, , Poland
Local Institution - 301
Elblag, , Poland
Local Institution - 307
Katowice, , Poland
Local Institution - 300
Krakow, , Poland
Local Institution - 308
Krakow, , Poland
Local Institution - 310
Nowa Sól, , Poland
Local Institution - 313
Onyksowa 10, , Poland
Local Institution - 312
Sochaczew, , Poland
Local Institution - 306
Torun, , Poland
Local Institution - 303
Warsaw, , Poland
Local Institution - 309
Wroclaw, , Poland
Local Institution - 400
Brasov, , Romania
Local Institution - 404
Bucharest, , Romania
Local Institution - 402
Bucharest, , Romania
Local Institution - 403
Bucharest, , Romania
Local Institution - 604
A Coruña, , Spain
Local Institution - 607
Barcelona, , Spain
Local Institution - 606
Córdoba, , Spain
Local Institution - 605
Mérida, , Spain
Local Institution - 601
Sabadell, , Spain
Local Institution - 602
Santiago de Compostela, , Spain
Local Institution - 603
Seville, , Spain
Local Institution - 702
Adapazarı, , Turkey (Türkiye)
Local Institution - 707
Altındağ/Ankara, , Turkey (Türkiye)
Local Institution - 700
Ankara, , Turkey (Türkiye)
Local Institution - 701
Edirne, , Turkey (Türkiye)
Local Institution - 705
Istanbul, , Turkey (Türkiye)
Local Institution - 706
Izmir, , Turkey (Türkiye)
Local Institution - 704
Karabağlar, , Turkey (Türkiye)
Local Institution - 703
Trabzon, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1265-3951
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-004108-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-99677-AS-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.