A Study of CC-99677 in Participants With Active Ankylosin... | NCT04947579 | Trialant
NCT04947579
Sponsor
Celgene
Status
Terminated
Last Update Posted
May 1, 2024Actual
Enrollment
167Actual
Phase
Phase 2
Conditions
Spondylitis, Ankylosing
Interventions
CC-99677
Placebo
Countries
United States
China
Czechia
Germany
Poland
Romania
Spain
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
NCT04947579
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CC-99677-AS-001
Secondary IDs
ID
Type
Description
Link
U1111-1265-3951
Registry Identifier
UTN Number
2019-004108-37
EudraCT Number
Brief Title
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
Acronym
AS SpA axSpA
Organization
CelgeneINDUSTRY
Status Module
Record Verification Date
Apr 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study has been terminated due to Non-Safety reasons because of lack of efficacy in the short-term acute phase.
Expanded Access Info
No
Start Date
Aug 25, 2021Actual
Primary Completion Date
Feb 21, 2023Actual
Completion Date
Feb 21, 2023Actual
First Submitted Date
Jun 23, 2021
First Submission Date that Met QC Criteria
Jun 23, 2021
First Posted Date
Jul 1, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Feb 21, 2024
Results First Submitted that Met QC Criteria
Apr 3, 2024
Results First Posted Date
May 1, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 3, 2024
Last Update Posted Date
May 1, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
CelgeneINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Spondylitis, Ankylosing
Keywords
Ankylosing Spondylitis
CC-99677
MK2inhibitor
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
167Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Administration of CC-99677 150 mg QD PO
Experimental
49 participants will be randomized to CC-99677 150 mg in biologic naive main study
Drug: CC-99677
Administration of CC-99677 60mg QD PO
Experimental
49 participants will be randomized to CC-99677 60 mg in biologic naive main study
Drug: CC-99677
Administration of Placebo QD PO
Placebo Comparator
49 participants will be randomized to placebo in biologic naive main study
Other: Placebo
Administration of CC-99677 150 mg QD PO.
Experimental
20 participants will be randomized to CC-99677 150 mg in biologic-failure substudy
Drug: CC-99677
Administration of CC-99677 60mg QD PO.
Experimental
20 participants will be randomized to CC-99677 60 mg in biologic-failure substudy
Drug: CC-99677
Placebo additional dose cohort
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CC-99677
Drug
Oral
Administration of CC-99677 150 mg QD PO
Administration of CC-99677 150 mg QD PO.
Administration of CC-99677 60mg QD PO
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Measure
Description
Time Frame
Percentage of Participants Who Achieve ASAS 40 at Week 12
Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 40% and ≥ 2 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening at all from baseline in the remaining domain. 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).
Other Outcomes
Not provided
Eligibility Module
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
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.
Participants originally randomized to the CC-99677 60 mg or 150 mg Biologic Naive or Biologic Failure arms in the Placebo-Controlled period continued receiving the same intervention until week 64 in the Long-Term Extension period.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo Biologic Naive
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
10 participants will be randomized to placebo in biologic-failure substudy
Other: Placebo
Administration of CC-99677 60mg QD PO.
Placebo
Other
Oral
Administration of Placebo QD PO
Placebo additional dose cohort
Week 12
Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12
ASDAS-CRP is a score of disease activity that combines patient reported assessments of back pain (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] question 2), duration of morning stiffness (BASDAI question 6), peripheral joint pain and/or swelling (BASDAI question 3), general wellbeing, and CRP in a weighted manner. The cut-off values for disease activity states and improvement scores are defined as follows: <1.3 inactive disease, ≥1.3 and <2.1 low disease activity, ≥2.1 and ≤3.5 high disease activity and 3.5 very high disease activity. The minimum clinically important difference (MCID) are defined as: change of at least 1.1 unit for 'clinically important improvement' and change of at least 2.0 units for 'major improvement'. Baseline is the last non-missing value on or before the date of the first dose of investigational product. ASDAS-CRP Formula: 0.12xBack Pain+0.06xDuration of Morning Stiffness+0.11xPatient Global+0.07xPeripheral Pain/Swelling+0.58xln(CRP+1)
Baseline and Week 12
Change From Baseline in BASDAI at Week 12
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a composite score based on a self-administered survey of six questions using a 0 to 10 unit numerical rating scale (NRS) that assesses five major symptoms of AS during the last week: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater is considered to be indicative of active AS disease. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
Baseline and Week 12
Change From Baseline in BASFI at Week 12
Bath Ankylosing Spondylitis Functional Index (BASFI) is a composite score based on a self administered survey of ten questions using a 0 to 10 unit numerical rating scale (NRS) that assesses degree of mobility and functional ability during the last week. The questionnaire consists of eight questions regarding function in AS and the two last questions reflecting ability to cope with everyday life. The left-hand box of 0 represents "easy," and the right-hand box represents "impossible." The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. A higher BASFI score correlates to reduced functional ability. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
Baseline and Week 12
Change From Baseline in the SPARCC SI Joint Score at Week 12
Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the sacroiliac joints. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
Baseline and Week 12
Change From Baseline in the SPARCC Spine Score at Week 12
Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the total spine. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) were scored for bone marrow edema. A single DVU has 18 scoring units, and each has score of 0 or 1, bringing the maximum total score to 414, the sum ranges from 0 to 414 with higher scores reflecting worse disease.
Baseline is the last non-missing value on or before the date of the first dose of investigational product.
Baseline and Week 12
Percent Change From Baseline in hsCRP at Week 12
Percent change from baseline in high-sensitivity C-reactive protein (hsCRP). Baseline is the last non-missing value on or before the date of the first dose of investigational product.
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
FG002
CC-99677 150 mg Biologic Naive
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
FG003
Placebo Biologic Failure
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
FG004
CC-99677 60 mg Biologic Failure
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
FG005
CC-99677 150 mg Biologic Failure
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
FG00049 subjects
FG00149 subjects
FG00249 subjects
FG0035 subjects
FG0047 subjects
FG0058 subjects
COMPLETED
FG00042 subjects
FG00142 subjects
FG00239 subjects
FG0033 subjects
FG0045 subjects
FG0057 subjects
NOT COMPLETED
FG0007 subjects
FG0017 subjects
FG00210 subjects
FG0032 subjects
FG0042 subjects
FG0051 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Other reasons
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Study terminated by sponsor
FG0005 subjects
FG0016 subjects
FG0027 subjects
FG0031 subjects
FG004
Protocol Deviation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Week 12 - Week 64 (Long-Term Extension)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00163 subjects
FG00261 subjects1 participant discontinued in the Placebo-Controlled period but entered the Long-Term Extension period.
FG0030 subjects
FG0047 subjects
FG0058 subjects
Placebo Patients Re-randomized to CC-99677 60 mg
FG0000 subjects
FG00121 subjects
FG0020 subjects
FG0030 subjects
Placebo Patients Re-randomized to CC-99677 150 mg
FG0000 subjects
FG0010 subjects
FG00221 subjects
FG0030 subjects
COMPLETED
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG00162 subjects
FG00260 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo Biologic Naive
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
BG001
CC-99677 60 mg Biologic Naive
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
BG002
CC-99677 150 mg Biologic Naive
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
BG003
Placebo Biologic Failure
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
BG004
CC-99677 60 mg Biologic Failure
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
BG005
CC-99677 150 mg Biologic Failure
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00049
BG00149
BG00249
BG0035
BG0047
BG0058
BG006167
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00044.1± 10.27
BG00140.5± 11.78
BG00240.4± 9.75
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0016
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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).
All treated participants who have non-missing response at week 12
Posted
Number
Percentage of Participants
Week 12
ID
Title
Description
OG000
Placebo Biologic Naive
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
OG001
CC-99677 60 mg Biologic Naive
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
OG002
CC-99677 150 mg Biologic Naive
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
OG003
Placebo Biologic Failure
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
OG004
CC-99677 60 mg Biologic Failure
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
OG005
CC-99677 150 mg Biologic Failure
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
Units
Counts
Participants
OG00041
OG00143
OG00241
OG003
Title
Denominators
Categories
Title
Measurements
OG00048.8
OG00151.2
OG00256.1
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.829
Stratified difference
2.4
2-Sided
95
-18.2
22.7
CC99677 60 mg - Placebo
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieve ASAS 40 at Week 12
Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 40% and ≥ 2 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening at all from baseline in the remaining domain. 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).
All treated participants who have non-missing response at week 12
Posted
Number
Percentage of Participants
Week 12
ID
Title
Description
OG000
Placebo Biologic Naive
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
OG001
CC-99677 60 mg Biologic Naive
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
OG002
CC-99677 150 mg Biologic Naive
Secondary
Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12
ASDAS-CRP is a score of disease activity that combines patient reported assessments of back pain (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] question 2), duration of morning stiffness (BASDAI question 6), peripheral joint pain and/or swelling (BASDAI question 3), general wellbeing, and CRP in a weighted manner. The cut-off values for disease activity states and improvement scores are defined as follows: <1.3 inactive disease, ≥1.3 and <2.1 low disease activity, ≥2.1 and ≤3.5 high disease activity and 3.5 very high disease activity. The minimum clinically important difference (MCID) are defined as: change of at least 1.1 unit for 'clinically important improvement' and change of at least 2.0 units for 'major improvement'. Baseline is the last non-missing value on or before the date of the first dose of investigational product. ASDAS-CRP Formula: 0.12xBack Pain+0.06xDuration of Morning Stiffness+0.11xPatient Global+0.07xPeripheral Pain/Swelling+0.58xln(CRP+1)
All treated participants with baseline and week 12 measurements
Posted
Mean
Standard Deviation
Units on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo Biologic Naive
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
OG001
CC-99677 60 mg Biologic Naive
Secondary
Change From Baseline in BASDAI at Week 12
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a composite score based on a self-administered survey of six questions using a 0 to 10 unit numerical rating scale (NRS) that assesses five major symptoms of AS during the last week: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater is considered to be indicative of active AS disease. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
All treated participants with baseline and week 12 measurements
Posted
Mean
Standard Deviation
Units on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo Biologic Naive
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
OG001
CC-99677 60 mg Biologic Naive
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
OG002
Secondary
Change From Baseline in BASFI at Week 12
Bath Ankylosing Spondylitis Functional Index (BASFI) is a composite score based on a self administered survey of ten questions using a 0 to 10 unit numerical rating scale (NRS) that assesses degree of mobility and functional ability during the last week. The questionnaire consists of eight questions regarding function in AS and the two last questions reflecting ability to cope with everyday life. The left-hand box of 0 represents "easy," and the right-hand box represents "impossible." The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. A higher BASFI score correlates to reduced functional ability. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
All treated participants with baseline and week 12 measurements
Posted
Mean
Standard Deviation
Units on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo Biologic Naive
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
OG001
CC-99677 60 mg Biologic Naive
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
OG002
CC-99677 150 mg Biologic Naive
Secondary
Change From Baseline in the SPARCC SI Joint Score at Week 12
Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the sacroiliac joints. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
All treated participants with baseline and week 12 measurements
Posted
Mean
Standard Deviation
Units on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo Biologic Naive
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
OG001
CC-99677 60 mg Biologic Naive
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
Secondary
Change From Baseline in the SPARCC Spine Score at Week 12
Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the total spine. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) were scored for bone marrow edema. A single DVU has 18 scoring units, and each has score of 0 or 1, bringing the maximum total score to 414, the sum ranges from 0 to 414 with higher scores reflecting worse disease.
Baseline is the last non-missing value on or before the date of the first dose of investigational product.
All treated participants with baseline and week 12 measurements
Posted
Mean
Standard Deviation
Units on a scale
Baseline and Week 12
ID
Title
Description
OG000
Placebo Biologic Naive
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
OG001
CC-99677 60 mg Biologic Naive
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
OG002
CC-99677 150 mg Biologic Naive
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
Secondary
Percent Change From Baseline in hsCRP at Week 12
Percent change from baseline in high-sensitivity C-reactive protein (hsCRP). Baseline is the last non-missing value on or before the date of the first dose of investigational product.
All treated participants with baseline and week 12 measurements
Posted
Mean
Standard Deviation
Percent change in hsCRP
Baseline and Week 12
ID
Title
Description
OG000
Placebo Biologic Naive
Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
OG001
CC-99677 60 mg Biologic Naive
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
OG002
CC-99677 150 mg Biologic Naive
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
OG003
Placebo Biologic Failure
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
Time Frame
Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
Description
Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
CC-99677 150 mg Biologic Naive
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
0
49
0
49
11
49
EG001
CC-99677 60 mg Biologic Naive
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
0
49
0
49
26
49
EG002
Placebo Biologic Naive
Placebo Biologic Naive QD PO from week 0 - 12
0
7
1
7
0
7
EG003
Placebo to CC-99677 150 mg Biologic Naive
At week 12, participants rerandomized to CC-99677 150 mg PO QD through Week 64 or until early discontinuation
1
21
3
21
8
21
EG004
Placebo to CC-99677 60 mg Biologic Naive
At week 12, participants rerandomized to CC-99677 60 mg PO QD through Week 64 or until early discontinuation
0
21
0
21
7
21
EG005
CC-99677 150 mg Biologic Failure
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
0
8
3
8
6
8
EG006
CC-99677 60 mg Biologic Failure
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
0
7
0
7
4
7
EG007
Placebo Biologic Failure
Placebo Biologic Failure QD PO from week 0 - 12
0
2
1
2
1
2
EG008
Placebo to CC-99677 150 mg Biologic Failure
At week 12, participants rerandomized to CC-99677 150 mg PO QD through Week 64 or until early discontinuation
0
1
0
1
1
1
EG009
Placebo to CC-99677 60 mg Biologic Failure
At week 12, participants rerandomized to CC-99677 60 mg PO QD through Week 64 or until early discontinuation
0
2
0
2
1
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial infarction
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG0031 affected21 at risk
EG0040 affected21 at risk
EG0050 affected8 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
Colitis ulcerative
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Asthenia
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0021 affected7 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Metastases to peritoneum
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG0030 affected21 at risk
EG0040 affected21 at risk
EG0051 affected8 at risk
EG0060 affected7 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected2 at risk
Iridocyclitis
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0013 affected49 at risk
EG0020 affected7 at risk
EG003
Swelling of eyelid
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected49 at risk
EG0020 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected49 at risk
EG0020 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected49 at risk
EG0020 affected7 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0002 affected49 at risk
EG0018 affected49 at risk
EG0020 affected7 at risk
EG003
Genital candidiasis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected49 at risk
EG0020 affected7 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0004 affected49 at risk
EG0013 affected49 at risk
EG0020 affected7 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Otitis media
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0002 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected49 at risk
EG0020 affected7 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0002 affected49 at risk
EG0011 affected49 at risk
EG0020 affected7 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0016 affected49 at risk
EG0020 affected7 at risk
EG003
Viral infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0001 affected49 at risk
EG0011 affected49 at risk
EG0020 affected7 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0012 affected49 at risk
EG0020 affected7 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0001 affected49 at risk
EG0013 affected49 at risk
EG0020 affected7 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0011 affected49 at risk
EG0020 affected7 at risk
EG003
Transaminases increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Ankylosing spondylitis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0012 affected49 at risk
EG0020 affected7 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0001 affected49 at risk
EG0011 affected49 at risk
EG0020 affected7 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0002 affected49 at risk
EG0013 affected49 at risk
EG0020 affected7 at risk
EG003
Radiculopathy
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 affected49 at risk
EG0010 affected49 at risk
EG0020 affected7 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
OG003
Placebo Biologic Failure
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
OG004
CC-99677 60 mg Biologic Failure
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
OG005
CC-99677 150 mg Biologic Failure
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
Units
Counts
Participants
OG00041
OG00143
OG00241
OG0033
OG0046
OG0057
Title
Denominators
Categories
Title
Measurements
OG00022.0
OG00125.6
OG00234.1
OG00333.3
OG00450.0
OG00528.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.725
Stratified difference
3.3
2-Sided
95
-14.9
21.0
CC99677 60 mg - Placebo
Superiority
OG000
OG002
Cochran-Mantel-Haenszel
0.219
Stratfied difference
12.2
2-Sided
95
-7.2
30.5
CC99677 150 mg - Placebo
Superiority
CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
OG002
CC-99677 150 mg Biologic Naive
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
OG003
Placebo Biologic Failure
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
OG004
CC-99677 60 mg Biologic Failure
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
OG005
CC-99677 150 mg Biologic Failure
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
Units
Counts
Participants
OG00040
OG00143
OG00241
OG0033
OG0045
OG0057
Title
Denominators
Categories
Title
Measurements
OG000-0.69± 0.856
OG001-0.87± 0.681
OG002-0.80± 0.869
OG003-0.84± 0.621
OG004-1.02± 0.464
OG005-0.44± 0.323
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Longitudinal data analysis model
0.299
Difference in Adjusted Means
-0.17
Standard Error of the Mean
0.167
2-Sided
95
-0.50
0.16
CC99677 60 mg - Placebo
Superiority
OG000
OG002
Longitudinal data analysis model
0.488
Difference in Adjusted Means
-0.12
Standard Error of the Mean
0.168
2-Sided
95
-0.45
0.22
CC99677 150 mg - Placebo
Superiority
CC-99677 150 mg Biologic Naive
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
OG003
Placebo Biologic Failure
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
OG004
CC-99677 60 mg Biologic Failure
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
OG005
CC-99677 150 mg Biologic Failure
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
Units
Counts
Participants
OG00043
OG00143
OG00241
OG0033
OG0046
OG0057
Title
Denominators
Categories
Title
Measurements
OG000-1.88± 1.862
OG001-1.96± 1.494
OG002-2.03± 2.080
OG003-1.63± 0.651
OG004-2.20± 1.394
OG005-1.43± 1.517
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Longitudinal data analysis model
0.970
Difference in Adjusted Means
0.01
Standard Error of the Mean
0.391
2-Sided
95
-0.76
0.79
CC99677 60 mg - Placebo
Superiority
OG000
OG002
Longitudinal data analysis model
0.668
Difference in Adjusted Means
-0.17
Standard Error of the Mean
0.393
2-Sided
95
-0.95
0.61
CC99677 150 mg - Placebo
Superiority
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
OG003
Placebo Biologic Failure
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
OG004
CC-99677 60 mg Biologic Failure
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
OG005
CC-99677 150 mg Biologic Failure
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
Units
Counts
Participants
OG00041
OG00143
OG00241
OG0033
OG0046
OG0057
Title
Denominators
Categories
Title
Measurements
OG000-1.22± 1.727
OG001-1.33± 1.985
OG002-1.28± 2.542
OG003-1.77± 0.850
OG004-1.47± 1.841
OG005-1.29± 0.703
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Longitudinal data analysis model
0.890
Difference in Adjusted Means
0.06
Standard Error of the Mean
0.416
2-Sided
95
-0.77
0.88
CC99677 60 mg - Placebo
Superiority
OG000
OG002
Longitudinal data analysis model
0.545
Difference in Adjusted Means
0.25
Standard Error of the Mean
0.417
2-Sided
95
-0.57
1.08
CC99677 150 mg - Placebo
Superiority
OG002
CC-99677 150 mg Biologic Naive
CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
OG003
Placebo Biologic Failure
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
OG004
CC-99677 60 mg Biologic Failure
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
OG005
CC-99677 150 mg Biologic Failure
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
Units
Counts
Participants
OG00038
OG00143
OG00239
OG0033
OG0045
OG0057
Title
Denominators
Categories
Title
Measurements
OG0000.25± 3.168
OG001-0.81± 5.453
OG002-1.72± 6.084
OG003-0.17± 1.258
OG004-3.00± 7.608
OG005-3.00± 4.093
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Longitudinal data analysis model
0.778
Difference in Adjusted Means
-0.28
Standard Error of the Mean
0.999
2-Sided
95
-2.26
1.70
CC99677 60 mg - Placebo
Superiority
OG000
OG002
Longitudinal data analysis model
0.330
Difference in Adjusted Means
-1.00
Standard Error of the Mean
1.022
2-Sided
95
-3.02
1.03
CC99677 150 mg - Placebo
Superiority
OG003
Placebo Biologic Failure
Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
OG004
CC-99677 60 mg Biologic Failure
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
OG005
CC-99677 150 mg Biologic Failure
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
Units
Counts
Participants
OG00038
OG00143
OG00239
OG0033
OG0045
OG0057
Title
Denominators
Categories
Title
Measurements
OG000-0.92± 7.557
OG001-1.53± 8.331
OG002-1.86± 7.081
OG003-8.17± 7.371
OG004-2.40± 5.128
OG005-2.71± 8.640
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Longitudinal data analysis model
0.600
Difference in Adjusted Means
-0.82
Standard Error of the Mean
1.567
2-Sided
95
-3.93
2.28
CC99677 60 mg - Placebo
Superiority
OG000
OG002
Longitudinal data analysis model
0.416
Difference in Adjusted Means
-1.31
Standard Error of the Mean
1.605
2-Sided
95
-4.49
1.87
CC99677 150 mg - Placebo
Superiority
OG004
CC-99677 60 mg Biologic Failure
CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
OG005
CC-99677 150 mg Biologic Failure
CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation