Spondylitis, Ankylosing
Conditions
Keywords
Ankylosing Spondylitis, CC-99677, MK2inhibitor, Spinal Diseases, Bone Diseases, Musculoskeletal Diseases, Arthritis, Joint Diseases
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.
Interventions
Oral
Oral
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve ASAS 20 at Week 12 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12 | Baseline and 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) |
| Change From Baseline in BASDAI at Week 12 | Baseline and 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. |
| Change From Baseline in BASFI at Week 12 | Baseline and 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. |
| Percentage of Participants Who Achieve ASAS 40 at Week 12 | 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). |
| Change From Baseline in the SPARCC Spine Score at Week 12 | Baseline and 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. |
| Percent Change From Baseline in hsCRP at Week 12 | Baseline and 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. |
| Change From Baseline in the SPARCC SI Joint Score at Week 12 | Baseline and 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. |
Countries
China, Czechia, Germany, Poland, Romania, Spain, Turkey (Türkiye), United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 49 |
| CC-99677 60 mg Biologic Naive CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation | 49 |
| CC-99677 150 mg Biologic Naive CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation | 49 |
| 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 | 5 |
| CC-99677 60 mg Biologic Failure CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation | 7 |
| CC-99677 150 mg Biologic Failure CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation | 8 |
| Total | 167 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Week 0 - Week 12 (Placebo-Controlled) | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 |
| Week 0 - Week 12 (Placebo-Controlled) | Other reasons | 0 | 0 | 1 | 0 | 0 | 0 |
| Week 0 - Week 12 (Placebo-Controlled) | Protocol Deviation | 1 | 0 | 0 | 0 | 0 | 0 |
| Week 0 - Week 12 (Placebo-Controlled) | Study terminated by sponsor | 5 | 6 | 7 | 1 | 0 | 1 |
| Week 0 - Week 12 (Placebo-Controlled) | Withdrawal by Subject | 1 | 1 | 2 | 0 | 2 | 0 |
| Week 12 - Week 64 (Long-Term Extension) | Adverse Event | 0 | 1 | 0 | 0 | 0 | 1 |
| Week 12 - Week 64 (Long-Term Extension) | Death | 0 | 0 | 1 | 0 | 0 | 0 |
| Week 12 - Week 64 (Long-Term Extension) | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 |
| Week 12 - Week 64 (Long-Term Extension) | Other reasons | 0 | 5 | 8 | 0 | 1 | 0 |
| Week 12 - Week 64 (Long-Term Extension) | Study terminated by sponsor | 0 | 54 | 46 | 0 | 5 | 4 |
| Week 12 - Week 64 (Long-Term Extension) | Withdrawal by Subject | 0 | 2 | 4 | 0 | 1 | 3 |
Baseline characteristics
| Characteristic | Placebo Biologic Naive | CC-99677 60 mg Biologic Naive | CC-99677 150 mg Biologic Naive | Placebo Biologic Failure | CC-99677 60 mg Biologic Failure | CC-99677 150 mg Biologic Failure | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 44.1 Years STANDARD_DEVIATION 10.27 | 40.5 Years STANDARD_DEVIATION 11.78 | 40.4 Years STANDARD_DEVIATION 9.75 | 43.8 Years STANDARD_DEVIATION 7.16 | 44.4 Years STANDARD_DEVIATION 10.06 | 42.5 Years STANDARD_DEVIATION 9.46 | 41.9 Years STANDARD_DEVIATION 10.48 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 47 Participants | 49 Participants | 5 Participants | 7 Participants | 8 Participants | 163 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 48 Participants | 48 Participants | 48 Participants | 5 Participants | 7 Participants | 8 Participants | 164 Participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 12 Participants | 1 Participants | 1 Participants | 0 Participants | 28 Participants |
| Sex: Female, Male Male | 41 Participants | 43 Participants | 37 Participants | 4 Participants | 6 Participants | 8 Participants | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 49 | 0 / 7 | 1 / 21 | 0 / 21 | 0 / 8 | 0 / 7 | 0 / 2 | 0 / 1 | 0 / 2 |
| other Total, other adverse events | 11 / 49 | 26 / 49 | 0 / 7 | 8 / 21 | 7 / 21 | 6 / 8 | 4 / 7 | 1 / 2 | 1 / 1 | 1 / 2 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 | 1 / 7 | 3 / 21 | 0 / 21 | 3 / 8 | 0 / 7 | 1 / 2 | 0 / 1 | 0 / 2 |
Outcome results
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).
Time frame: Week 12
Population: All treated participants who have non-missing response at week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Biologic Naive | Percentage of Participants Who Achieve ASAS 20 at Week 12 | 48.8 Percentage of Participants |
| CC-99677 60 mg Biologic Naive | Percentage of Participants Who Achieve ASAS 20 at Week 12 | 51.2 Percentage of Participants |
| CC-99677 150 mg Biologic Naive | Percentage of Participants Who Achieve ASAS 20 at Week 12 | 56.1 Percentage of Participants |
| Placebo Biologic Failure | Percentage of Participants Who Achieve ASAS 20 at Week 12 | 66.7 Percentage of Participants |
| CC-99677 60 mg Biologic Failure | Percentage of Participants Who Achieve ASAS 20 at Week 12 | 83.3 Percentage of Participants |
| CC-99677 150 mg Biologic Failure | Percentage of Participants Who Achieve ASAS 20 at Week 12 | 57.1 Percentage of Participants |
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)
Time frame: Baseline and Week 12
Population: All treated participants with baseline and week 12 measurements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Biologic Naive | Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12 | -0.69 Units on a scale | Standard Deviation 0.856 |
| CC-99677 60 mg Biologic Naive | Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12 | -0.87 Units on a scale | Standard Deviation 0.681 |
| CC-99677 150 mg Biologic Naive | Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12 | -0.80 Units on a scale | Standard Deviation 0.869 |
| Placebo Biologic Failure | Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12 | -0.84 Units on a scale | Standard Deviation 0.621 |
| CC-99677 60 mg Biologic Failure | Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12 | -1.02 Units on a scale | Standard Deviation 0.464 |
| CC-99677 150 mg Biologic Failure | Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12 | -0.44 Units on a scale | Standard Deviation 0.323 |
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.
Time frame: Baseline and Week 12
Population: All treated participants with baseline and week 12 measurements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Biologic Naive | Change From Baseline in BASDAI at Week 12 | -1.88 Units on a scale | Standard Deviation 1.862 |
| CC-99677 60 mg Biologic Naive | Change From Baseline in BASDAI at Week 12 | -1.96 Units on a scale | Standard Deviation 1.494 |
| CC-99677 150 mg Biologic Naive | Change From Baseline in BASDAI at Week 12 | -2.03 Units on a scale | Standard Deviation 2.08 |
| Placebo Biologic Failure | Change From Baseline in BASDAI at Week 12 | -1.63 Units on a scale | Standard Deviation 0.651 |
| CC-99677 60 mg Biologic Failure | Change From Baseline in BASDAI at Week 12 | -2.20 Units on a scale | Standard Deviation 1.394 |
| CC-99677 150 mg Biologic Failure | Change From Baseline in BASDAI at Week 12 | -1.43 Units on a scale | Standard Deviation 1.517 |
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.
Time frame: Baseline and Week 12
Population: All treated participants with baseline and week 12 measurements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Biologic Naive | Change From Baseline in BASFI at Week 12 | -1.22 Units on a scale | Standard Deviation 1.727 |
| CC-99677 60 mg Biologic Naive | Change From Baseline in BASFI at Week 12 | -1.33 Units on a scale | Standard Deviation 1.985 |
| CC-99677 150 mg Biologic Naive | Change From Baseline in BASFI at Week 12 | -1.28 Units on a scale | Standard Deviation 2.542 |
| Placebo Biologic Failure | Change From Baseline in BASFI at Week 12 | -1.77 Units on a scale | Standard Deviation 0.85 |
| CC-99677 60 mg Biologic Failure | Change From Baseline in BASFI at Week 12 | -1.47 Units on a scale | Standard Deviation 1.841 |
| CC-99677 150 mg Biologic Failure | Change From Baseline in BASFI at Week 12 | -1.29 Units on a scale | Standard Deviation 0.703 |
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.
Time frame: Baseline and Week 12
Population: All treated participants with baseline and week 12 measurements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Biologic Naive | Change From Baseline in the SPARCC SI Joint Score at Week 12 | 0.25 Units on a scale | Standard Deviation 3.168 |
| CC-99677 60 mg Biologic Naive | Change From Baseline in the SPARCC SI Joint Score at Week 12 | -0.81 Units on a scale | Standard Deviation 5.453 |
| CC-99677 150 mg Biologic Naive | Change From Baseline in the SPARCC SI Joint Score at Week 12 | -1.72 Units on a scale | Standard Deviation 6.084 |
| Placebo Biologic Failure | Change From Baseline in the SPARCC SI Joint Score at Week 12 | -0.17 Units on a scale | Standard Deviation 1.258 |
| CC-99677 60 mg Biologic Failure | Change From Baseline in the SPARCC SI Joint Score at Week 12 | -3.00 Units on a scale | Standard Deviation 7.608 |
| CC-99677 150 mg Biologic Failure | Change From Baseline in the SPARCC SI Joint Score at Week 12 | -3.00 Units on a scale | Standard Deviation 4.093 |
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.
Time frame: Baseline and Week 12
Population: All treated participants with baseline and week 12 measurements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Biologic Naive | Change From Baseline in the SPARCC Spine Score at Week 12 | -0.92 Units on a scale | Standard Deviation 7.557 |
| CC-99677 60 mg Biologic Naive | Change From Baseline in the SPARCC Spine Score at Week 12 | -1.53 Units on a scale | Standard Deviation 8.331 |
| CC-99677 150 mg Biologic Naive | Change From Baseline in the SPARCC Spine Score at Week 12 | -1.86 Units on a scale | Standard Deviation 7.081 |
| Placebo Biologic Failure | Change From Baseline in the SPARCC Spine Score at Week 12 | -8.17 Units on a scale | Standard Deviation 7.371 |
| CC-99677 60 mg Biologic Failure | Change From Baseline in the SPARCC Spine Score at Week 12 | -2.40 Units on a scale | Standard Deviation 5.128 |
| CC-99677 150 mg Biologic Failure | Change From Baseline in the SPARCC Spine Score at Week 12 | -2.71 Units on a scale | Standard Deviation 8.64 |
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).
Time frame: Week 12
Population: All treated participants who have non-missing response at week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Biologic Naive | Percentage of Participants Who Achieve ASAS 40 at Week 12 | 22.0 Percentage of Participants |
| CC-99677 60 mg Biologic Naive | Percentage of Participants Who Achieve ASAS 40 at Week 12 | 25.6 Percentage of Participants |
| CC-99677 150 mg Biologic Naive | Percentage of Participants Who Achieve ASAS 40 at Week 12 | 34.1 Percentage of Participants |
| Placebo Biologic Failure | Percentage of Participants Who Achieve ASAS 40 at Week 12 | 33.3 Percentage of Participants |
| CC-99677 60 mg Biologic Failure | Percentage of Participants Who Achieve ASAS 40 at Week 12 | 50.0 Percentage of Participants |
| CC-99677 150 mg Biologic Failure | Percentage of Participants Who Achieve ASAS 40 at Week 12 | 28.6 Percentage of Participants |
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.
Time frame: Baseline and Week 12
Population: All treated participants with baseline and week 12 measurements
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Biologic Naive | Percent Change From Baseline in hsCRP at Week 12 | 72.83 Percent change in hsCRP | Standard Deviation 474.199 |
| CC-99677 60 mg Biologic Naive | Percent Change From Baseline in hsCRP at Week 12 | -1.43 Percent change in hsCRP | Standard Deviation 64.157 |
| CC-99677 150 mg Biologic Naive | Percent Change From Baseline in hsCRP at Week 12 | 20.88 Percent change in hsCRP | Standard Deviation 130.181 |
| Placebo Biologic Failure | Percent Change From Baseline in hsCRP at Week 12 | -13.68 Percent change in hsCRP | Standard Deviation 55.618 |
| CC-99677 60 mg Biologic Failure | Percent Change From Baseline in hsCRP at Week 12 | 8.52 Percent change in hsCRP | Standard Deviation 66.057 |
| CC-99677 150 mg Biologic Failure | Percent Change From Baseline in hsCRP at Week 12 | 452.34 Percent change in hsCRP | Standard Deviation 1226.664 |