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

Primary Purpose

Spondylitis, Ankylosing

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CC-99677
Placebo
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondylitis, Ankylosing focused on measuring Ankylosing Spondylitis, CC-99677, MK2inhibitor, Spinal Diseases, Bone Diseases, Musculoskeletal Diseases, Arthritis, Joint Diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution - 024
  • Local Institution - 021
  • Local Institution - 022
  • Local Institution - 025
  • Local Institution - 017
  • Local Institution - 026
  • Local Institution - 028
  • Local Institution - 004
  • Local Institution - 009
  • Local Institution - 003
  • Local Institution - 005
  • Local Institution - 002
  • Local Institution - 029
  • Local Institution - 006
  • Local Institution - 019
  • Local Institution - 008
  • Local Institution - 154
  • Local Institution - 151
  • Local Institution - 152
  • Local Institution - 153
  • Local Institution - 150
  • Local Institution - 205
  • Local Institution - 206
  • Local Institution - 207
  • Local Institution - 201
  • Local Institution - 211
  • Local Institution - 202
  • Local Institution - 203
  • Local Institution - 204
  • Local Institution - 900
  • Local Institution - 311
  • Local Institution - 315
  • Local Institution - 305
  • Local Institution - 302
  • Local Institution - 301
  • Local Institution - 307
  • Local Institution - 300
  • Local Institution - 308
  • Local Institution - 310
  • Local Institution - 313
  • Local Institution - 312
  • Local Institution - 306
  • Local Institution - 303
  • Local Institution - 309
  • Local Institution - 400
  • Local Institution - 404
  • Local Institution - 402
  • Local Institution - 403
  • Local Institution - 604
  • Local Institution - 607
  • Local Institution - 606
  • Local Institution - 605
  • Local Institution - 601
  • Local Institution - 602
  • Local Institution - 603
  • Local Institution - 702
  • Local Institution - 707
  • Local Institution - 700
  • Local Institution - 701
  • Local Institution - 705
  • Local Institution - 706
  • Local Institution - 704
  • Local Institution - 703

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

Administration of CC-99677 150 mg QD PO

Administration of CC-99677 60mg QD PO

Administration of Placebo QD PO

Administration of CC-99677 150 mg QD PO.

Administration of CC-99677 60mg QD PO.

Placebo additional dose cohort

Arm Description

49 participants will be randomized to CC-99677 150 mg in biologic naive main study

49 participants will be randomized to CC-99677 60 mg in biologic naive main study

49 participants will be randomized to placebo in biologic naive main study

20 participants will be randomized to CC-99677 150 mg in biologic-failure substudy

20 participants will be randomized to CC-99677 60 mg in biologic-failure substudy

10 participants will be randomized to placebo in biologic-failure substudy

Outcomes

Primary Outcome Measures

Assessment of ASAS 20
The Assessment In Spondyloarthritis International Society (ASAS) 20 is defined as improvement ≥ 20% and ≥ 1 unit on a scale of 0 to 10 in each of the 3 domains, with no worsening in the fourth, where the domains are physical function, total back pain, patient global assessment of disease, and inflammation.

Secondary Outcome Measures

Assessment of ASAS 40
The Assessment In Spondyloarthritis International Society (ASAS) 40 is defined as improvement ≥ 40% and ≥ 2 units on a scale of 0 to 10 in each of the 3 domains, with no worsening in the fourth, where the domains are physical function, total back pain, patient global assessment of disease, and inflammation.
Assessment of ASDAS-CRP
The Ankylosing Spondylitis Disease Activity with C-reactive protein as the acute-phase reactant (ASDAS-CRP)is a validated disease activity index in AS that combines participant reported assessments of back pain, morning stiffness, joint pain and/or swelling and general wellbeing.
Assessment of BASDAI
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a composite score based on a participant self-administered survey of six questions using a 0 to 10 unit numerical rating scale (NRS) that assesses the participant major symptoms of AS.
Assessment of BASFI
The Bath Ankylosing Spondylitis Functional Index (BASFI) is a composite score based on a participant self-administered survey of ten questions using a 0 to 10 unit numerical rating scale (NRS) that assesses a participant's degree of mobility and functional ability.
SPARCC score for the total spine and sacroiliac joints
Spinal and sacroiliac joint inflammation as measured by Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) score of sacroiliac joints and spine.
High-sensitivity C-reactive protein (hsCRP)
High-sensitivity C-reactive protein (hsCRP) provides an objective measure of disease activity in participants.
Incidence of Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.

Full Information

First Posted
June 23, 2021
Last Updated
June 29, 2023
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT04947579
Brief Title
A Study of CC-99677 in Participants With Active Ankylosing Spondylitis
Acronym
AS SpA axSpA
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
The study has been terminated due to Non-Safety reasons because of lack of efficacy in the short-term acute phase.
Study Start Date
August 25, 2021 (Actual)
Primary Completion Date
February 21, 2023 (Actual)
Study Completion Date
February 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylitis, Ankylosing
Keywords
Ankylosing Spondylitis, CC-99677, MK2inhibitor, Spinal Diseases, Bone Diseases, Musculoskeletal Diseases, Arthritis, Joint Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Administration of CC-99677 150 mg QD PO
Arm Type
Experimental
Arm Description
49 participants will be randomized to CC-99677 150 mg in biologic naive main study
Arm Title
Administration of CC-99677 60mg QD PO
Arm Type
Experimental
Arm Description
49 participants will be randomized to CC-99677 60 mg in biologic naive main study
Arm Title
Administration of Placebo QD PO
Arm Type
Placebo Comparator
Arm Description
49 participants will be randomized to placebo in biologic naive main study
Arm Title
Administration of CC-99677 150 mg QD PO.
Arm Type
Experimental
Arm Description
20 participants will be randomized to CC-99677 150 mg in biologic-failure substudy
Arm Title
Administration of CC-99677 60mg QD PO.
Arm Type
Experimental
Arm Description
20 participants will be randomized to CC-99677 60 mg in biologic-failure substudy
Arm Title
Placebo additional dose cohort
Arm Type
Placebo Comparator
Arm Description
10 participants will be randomized to placebo in biologic-failure substudy
Intervention Type
Drug
Intervention Name(s)
CC-99677
Intervention Description
Oral
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Assessment of ASAS 20
Description
The Assessment In Spondyloarthritis International Society (ASAS) 20 is defined as improvement ≥ 20% and ≥ 1 unit on a scale of 0 to 10 in each of the 3 domains, with no worsening in the fourth, where the domains are physical function, total back pain, patient global assessment of disease, and inflammation.
Time Frame
Up to week 12
Secondary Outcome Measure Information:
Title
Assessment of ASAS 40
Description
The Assessment In Spondyloarthritis International Society (ASAS) 40 is defined as improvement ≥ 40% and ≥ 2 units on a scale of 0 to 10 in each of the 3 domains, with no worsening in the fourth, where the domains are physical function, total back pain, patient global assessment of disease, and inflammation.
Time Frame
Up to week 12
Title
Assessment of ASDAS-CRP
Description
The Ankylosing Spondylitis Disease Activity with C-reactive protein as the acute-phase reactant (ASDAS-CRP)is a validated disease activity index in AS that combines participant reported assessments of back pain, morning stiffness, joint pain and/or swelling and general wellbeing.
Time Frame
Up to week 12
Title
Assessment of BASDAI
Description
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a composite score based on a participant self-administered survey of six questions using a 0 to 10 unit numerical rating scale (NRS) that assesses the participant major symptoms of AS.
Time Frame
Up to week 12
Title
Assessment of BASFI
Description
The Bath Ankylosing Spondylitis Functional Index (BASFI) is a composite score based on a participant self-administered survey of ten questions using a 0 to 10 unit numerical rating scale (NRS) that assesses a participant's degree of mobility and functional ability.
Time Frame
Up to week 12
Title
SPARCC score for the total spine and sacroiliac joints
Description
Spinal and sacroiliac joint inflammation as measured by Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) score of sacroiliac joints and spine.
Time Frame
Up to week 12
Title
High-sensitivity C-reactive protein (hsCRP)
Description
High-sensitivity C-reactive protein (hsCRP) provides an objective measure of disease activity in participants.
Time Frame
Up to week 12
Title
Incidence of Adverse Events (AEs)
Description
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.
Time Frame
From enrollment until at least 28 days after completion of study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb, MD
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 024
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001
Country
United States
Facility Name
Local Institution - 021
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
58297
Country
United States
Facility Name
Local Institution - 022
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
95037
Country
United States
Facility Name
Local Institution - 025
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Local Institution - 017
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Local Institution - 026
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
Local Institution - 028
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Local Institution - 004
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Local Institution - 009
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Local Institution - 003
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Local Institution - 005
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Local Institution - 002
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Local Institution - 029
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Local Institution - 006
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Facility Name
Local Institution - 019
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Local Institution - 008
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Local Institution - 154
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Local Institution - 151
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Facility Name
Local Institution - 152
City
Hangzhou
ZIP/Postal Code
310014
Country
China
Facility Name
Local Institution - 153
City
Huangpu District
ZIP/Postal Code
200000
Country
China
Facility Name
Local Institution - 150
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Local Institution - 205
City
Brno
ZIP/Postal Code
61141
Country
Czechia
Facility Name
Local Institution - 206
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Local Institution - 207
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Local Institution - 201
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Local Institution - 211
City
Praha 11
ZIP/Postal Code
148 00
Country
Czechia
Facility Name
Local Institution - 202
City
Praha 3
ZIP/Postal Code
13000
Country
Czechia
Facility Name
Local Institution - 203
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Local Institution - 204
City
Uherské Hradište
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
Local Institution - 900
City
Herne
ZIP/Postal Code
44649
Country
Germany
Facility Name
Local Institution - 311
City
Bialystok
ZIP/Postal Code
15-077
Country
Poland
Facility Name
Local Institution - 315
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Local Institution - 305
City
Bydgoszcz
ZIP/Postal Code
85-065
Country
Poland
Facility Name
Local Institution - 302
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Local Institution - 301
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Local Institution - 307
City
Katowice
ZIP/Postal Code
40-282
Country
Poland
Facility Name
Local Institution - 300
City
Krakow
ZIP/Postal Code
30-002
Country
Poland
Facility Name
Local Institution - 308
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Facility Name
Local Institution - 310
City
Nowa Sol
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Local Institution - 313
City
Onyksowa 10
ZIP/Postal Code
20-582
Country
Poland
Facility Name
Local Institution - 312
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Facility Name
Local Institution - 306
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Local Institution - 303
City
Warsaw
ZIP/Postal Code
02-691
Country
Poland
Facility Name
Local Institution - 309
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Facility Name
Local Institution - 400
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Local Institution - 404
City
Bucuresti
ZIP/Postal Code
011025
Country
Romania
Facility Name
Local Institution - 402
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Facility Name
Local Institution - 403
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Facility Name
Local Institution - 604
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Local Institution - 607
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 606
City
Cordoba
ZIP/Postal Code
14001
Country
Spain
Facility Name
Local Institution - 605
City
Merida
ZIP/Postal Code
06800
Country
Spain
Facility Name
Local Institution - 601
City
Sabadell
ZIP/Postal Code
8208
Country
Spain
Facility Name
Local Institution - 602
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution - 603
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Local Institution - 702
City
Adapazari
ZIP/Postal Code
54100
Country
Turkey
Facility Name
Local Institution - 707
City
Altındağ/Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Local Institution - 700
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Local Institution - 701
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Local Institution - 705
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Local Institution - 706
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Local Institution - 704
City
Karabaglar
ZIP/Postal Code
35360
Country
Turkey
Facility Name
Local Institution - 703
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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/
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/us/en/home.html
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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