Clinical trial NCT04947579: A Study of CC-99677 in Participants With Active Ankylosing Spondylitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Spondylitis, Ankylosing
Keywords: Ankylosing Spondylitis
CC-99677
MK2inhibitor
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2021-07-01
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Achieve ASAS 20 at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Who Achieve ASAS 40 at Week 12
timeFrame: Week 12
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in BASDAI at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in BASFI at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in the SPARCC SI Joint Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in the SPARCC Spine Score at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in hsCRP at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Local Institution - 024
state: Arizona
city: Gilbert
country: United States
facility: Local Institution - 021
state: Arizona
city: Phoenix
country: United States
facility: Local Institution - 022
state: Arizona
city: Tucson
country: United States
facility: Local Institution - 025
state: Arizona
city: Tustin
country: United States
facility: Local Institution - 017
state: California
city: Saint Clair Shores
country: United States
facility: Local Institution - 026
state: Michigan
city: Cleveland
country: United States
facility: Local Institution - 028
state: Ohio
city: Dayton
country: United States
facility: Local Institution - 004
state: Ohio
city: Portland
country: United States
facility: Local Institution - 009
state: Oregon
city: Duncansville
country: United States
facility: Local Institution - 003
state: Pennsylvania
city: Jackson
country: United States
facility: Local Institution - 005
state: Tennessee
city: Memphis
country: United States
facility: Local Institution - 002
state: Tennessee
city: Austin
country: United States
facility: Local Institution - 029
state: Texas
city: Colleyville
country: United States
facility: Local Institution - 006
state: Texas
city: Fort Worth
country: United States
facility: Local Institution - 019
state: Texas
city: Houston
country: United States
facility: Local Institution - 008
state: Texas
city: Shanghai
country: China
facility: Local Institution - 154
state: Shanghai
city: Guangzhou
country: China
facility: Local Institution - 151
city: Hangzhou
country: China
facility: Local Institution - 152
city: Huangpu District
country: China
facility: Local Institution - 153
city: Wuhan
country: China
facility: Local Institution - 150
city: Brno
country: Czechia
facility: Local Institution - 205
city: Ostrava
country: Czechia
facility: Local Institution - 206
city: Ostrava
country: Czechia
facility: Local Institution - 207
city: Pardubice
country: Czechia
facility: Local Institution - 201
city: Praha 11
country: Czechia
facility: Local Institution - 211
city: Praha 3
country: Czechia
facility: Local Institution - 202
city: Praha 4
country: Czechia
facility: Local Institution - 203
city: Uherské Hradište
country: Czechia
facility: Local Institution - 204
city: Herne
country: Germany
facility: Local Institution - 900
city: Bialystok
country: Poland
facility: Local Institution - 311
city: Bialystok
country: Poland
facility: Local Institution - 315
city: Bydgoszcz
country: Poland
facility: Local Institution - 305
city: Bydgoszcz
country: Poland
facility: Local Institution - 302
city: Elblag
country: Poland
facility: Local Institution - 301
city: Katowice
country: Poland
facility: Local Institution - 307
city: Krakow
country: Poland
facility: Local Institution - 300
city: Krakow
country: Poland
facility: Local Institution - 308
city: Nowa Sol
country: Poland
facility: Local Institution - 310
city: Onyksowa 10
country: Poland
facility: Local Institution - 313
city: Sochaczew
country: Poland
facility: Local Institution - 312
city: Torun
country: Poland
facility: Local Institution - 306
city: Warsaw
country: Poland
facility: Local Institution - 303
city: Wroclaw
country: Poland
facility: Local Institution - 309
city: Brasov
country: Romania
facility: Local Institution - 400
city: Bucuresti
country: Romania
facility: Local Institution - 404
city: Bucuresti
country: Romania
facility: Local Institution - 402
city: Bucuresti
country: Romania
facility: Local Institution - 403
city: A Coruña
country: Spain
facility: Local Institution - 604
city: Barcelona
country: Spain
facility: Local Institution - 607
city: Cordoba
country: Spain
facility: Local Institution - 606
city: Merida
country: Spain
facility: Local Institution - 605
city: Sabadell
country: Spain
facility: Local Institution - 601
city: Santiago De Compostela
country: Spain
facility: Local Institution - 602
city: Sevilla
country: Spain
facility: Local Institution - 603
city: Adapazari
country: Turkey
facility: Local Institution - 702
city: Altındağ/Ankara
country: Turkey
facility: Local Institution - 707
city: Ankara
country: Turkey
facility: Local Institution - 700
city: Edirne
country: Turkey
facility: Local Institution - 701
city: Istanbul
country: Turkey
facility: Local Institution - 705
city: Izmir
country: Turkey
facility: Local Institution - 706
city: Karabaglar
country: Turkey
facility: Local Institution - 704
city: Trabzon
country: Turkey
facility: Local Institution - 703
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb, MD
role: STUDY_DIRECTOR
References: