Study Stopped
The study has been terminated due to Non-Safety reasons because of lack of efficacy in the short-term acute phase.
A Study of CC-99677 in Participants With Active Ankylosing Spondylitis
AS SpA axSpA
A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects With Active Ankylosing Spondylitis
3 other identifiers
interventional
167
8 countries
63
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2021
Shorter than P25 for phase_2
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2021
CompletedFirst Posted
Study publicly available on registry
July 1, 2021
CompletedStudy Start
First participant enrolled
August 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2023
CompletedResults Posted
Study results publicly available
May 1, 2024
CompletedMay 1, 2024
April 1, 2024
1.5 years
June 23, 2021
February 21, 2024
April 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieve ASAS 20 at Week 12
Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 20% and ≥ 1 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining domain on a scale of 0 to 10. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are: * Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale \[NRS\]); * Total Back Pain NRS; * Function (the Bath Ankylosing Spondylitis Functional Index \[BASFI\] score NRS); * Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] NRS Questions #5 and #6 for morning stiffness).
Week 12
Secondary Outcomes (7)
Percentage of Participants Who Achieve ASAS 40 at Week 12
Week 12
Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12
Baseline and Week 12
Change From Baseline in BASDAI at Week 12
Baseline and Week 12
Change From Baseline in BASFI at Week 12
Baseline and Week 12
Change From Baseline in the SPARCC SI Joint Score at Week 12
Baseline and Week 12
- +2 more secondary outcomes
Study Arms (6)
Administration of CC-99677 150 mg QD PO
EXPERIMENTAL49 participants will be randomized to CC-99677 150 mg in biologic naive main study
Administration of CC-99677 60mg QD PO
EXPERIMENTAL49 participants will be randomized to CC-99677 60 mg in biologic naive main study
Administration of Placebo QD PO
PLACEBO COMPARATOR49 participants will be randomized to placebo in biologic naive main study
Administration of CC-99677 150 mg QD PO.
EXPERIMENTAL20 participants will be randomized to CC-99677 150 mg in biologic-failure substudy
Administration of CC-99677 60mg QD PO.
EXPERIMENTAL20 participants will be randomized to CC-99677 60 mg in biologic-failure substudy
Placebo additional dose cohort
PLACEBO COMPARATOR10 participants will be randomized to placebo in biologic-failure substudy
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (63)
Local Institution - 024
Flagstaff, Arizona, 86001, United States
Local Institution - 021
Gilbert, Arizona, 58297, United States
Local Institution - 022
Phoenix, Arizona, 95037, United States
Local Institution - 025
Tucson, Arizona, 85704, United States
Local Institution - 017
Tustin, California, 92780, United States
Local Institution - 026
Saint Clair Shores, Michigan, 48081, United States
Local Institution - 028
Cleveland, Ohio, 44106, United States
Local Institution - 004
Dayton, Ohio, 45417, United States
Local Institution - 009
Portland, Oregon, 97239, United States
Local Institution - 003
Duncansville, Pennsylvania, 16635, United States
Local Institution - 005
Jackson, Tennessee, 38305, United States
Local Institution - 002
Memphis, Tennessee, 38119, United States
Local Institution - 029
Austin, Texas, 78731, United States
Local Institution - 006
Colleyville, Texas, 76034, United States
Local Institution - 019
Fort Worth, Texas, 76107, United States
Local Institution - 008
Houston, Texas, 77099, United States
Local Institution - 154
Shanghai, Shanghai Municipality, 200040, China
Local Institution - 151
Guangzhou, 510630, China
Local Institution - 152
Hangzhou, 310014, China
Local Institution - 153
Huangpu District, 200000, China
Local Institution - 150
Wuhan, 430030, China
Local Institution - 205
Brno, 61141, Czechia
Local Institution - 206
Ostrava, 702 00, Czechia
Local Institution - 207
Ostrava, 702 00, Czechia
Local Institution - 201
Pardubice, 530 02, Czechia
Local Institution - 202
Prague, 13000, Czechia
Local Institution - 203
Prague, 140 00, Czechia
Local Institution - 211
Prague, 148 00, Czechia
Local Institution - 204
Uherské Hradište, 686 01, Czechia
Local Institution - 900
Herne, 44649, Germany
Local Institution - 311
Bialystok, 15-077, Poland
Local Institution - 315
Bialystok, 15-351, Poland
Local Institution - 305
Bydgoszcz, 85-065, Poland
Local Institution - 302
Bydgoszcz, 85-168, Poland
Local Institution - 301
Elblag, 82-300, Poland
Local Institution - 307
Katowice, 40-282, Poland
Local Institution - 300
Krakow, 30-002, Poland
Local Institution - 308
Krakow, 30-363, Poland
Local Institution - 310
Nowa Sól, 67-100, Poland
Local Institution - 313
Onyksowa 10, 20-582, Poland
Local Institution - 312
Sochaczew, 96-500, Poland
Local Institution - 306
Torun, 87-100, Poland
Local Institution - 303
Warsaw, 02-691, Poland
Local Institution - 309
Wroclaw, 52-416, Poland
Local Institution - 400
Brasov, 500283, Romania
Local Institution - 404
Bucharest, 011025, Romania
Local Institution - 402
Bucharest, 011172, Romania
Local Institution - 403
Bucharest, 011172, Romania
Local Institution - 604
A Coruña, 15006, Spain
Local Institution - 607
Barcelona, 08035, Spain
Local Institution - 606
Córdoba, 14001, Spain
Local Institution - 605
Mérida, 06800, Spain
Local Institution - 601
Sabadell, 8208, Spain
Local Institution - 602
Santiago de Compostela, 15706, Spain
Local Institution - 603
Seville, 41013, Spain
Local Institution - 702
Adapazarı, 54100, Turkey (Türkiye)
Local Institution - 707
Altındağ/Ankara, 06230, Turkey (Türkiye)
Local Institution - 700
Ankara, 06100, Turkey (Türkiye)
Local Institution - 701
Edirne, 22030, Turkey (Türkiye)
Local Institution - 705
Istanbul, 34098, Turkey (Türkiye)
Local Institution - 706
Izmir, 35100, Turkey (Türkiye)
Local Institution - 704
Karabağlar, 35360, Turkey (Türkiye)
Local Institution - 703
Trabzon, 61080, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb, MD
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2021
First Posted
July 1, 2021
Study Start
August 25, 2021
Primary Completion
February 21, 2023
Study Completion
February 21, 2023
Last Updated
May 1, 2024
Results First Posted
May 1, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- See Plan Description
- Access Criteria
- See Plan Description
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/