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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04947579
Acronym
AS SpA axSpA
Enrollment
167
Registered
2021-07-01
Start date
2021-08-25
Completion date
2023-02-21
Last updated
2024-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondylitis, Ankylosing

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

OTHERPlacebo

Oral

Sponsors

Celgene
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Percentage of Participants Who Achieve ASAS 20 at Week 12Week 12Percentage 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

MeasureTime frameDescription
Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12Baseline and Week 12ASDAS-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 12Baseline and Week 12Bath 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 12Baseline and Week 12Bath 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 12Week 12Percentage 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 12Baseline and Week 12Change 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 12Baseline and Week 12Percent 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 12Baseline and Week 12Change 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

ArmCount
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
Total167

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Week 0 - Week 12 (Placebo-Controlled)Adverse Event000100
Week 0 - Week 12 (Placebo-Controlled)Other reasons001000
Week 0 - Week 12 (Placebo-Controlled)Protocol Deviation100000
Week 0 - Week 12 (Placebo-Controlled)Study terminated by sponsor567101
Week 0 - Week 12 (Placebo-Controlled)Withdrawal by Subject112020
Week 12 - Week 64 (Long-Term Extension)Adverse Event010001
Week 12 - Week 64 (Long-Term Extension)Death001000
Week 12 - Week 64 (Long-Term Extension)Lost to Follow-up001000
Week 12 - Week 64 (Long-Term Extension)Other reasons058010
Week 12 - Week 64 (Long-Term Extension)Study terminated by sponsor05446054
Week 12 - Week 64 (Long-Term Extension)Withdrawal by Subject024013

Baseline characteristics

CharacteristicPlacebo Biologic NaiveCC-99677 60 mg Biologic NaiveCC-99677 150 mg Biologic NaivePlacebo Biologic FailureCC-99677 60 mg Biologic FailureCC-99677 150 mg Biologic FailureTotal
Age, Continuous44.1 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 Participants2 Participants0 Participants0 Participants0 Participants0 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
47 Participants47 Participants49 Participants5 Participants7 Participants8 Participants163 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants0 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
48 Participants48 Participants48 Participants5 Participants7 Participants8 Participants164 Participants
Sex: Female, Male
Female
8 Participants6 Participants12 Participants1 Participants1 Participants0 Participants28 Participants
Sex: Female, Male
Male
41 Participants43 Participants37 Participants4 Participants6 Participants8 Participants139 Participants

Adverse events

Event typeEG000
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 / 490 / 490 / 71 / 210 / 210 / 80 / 70 / 20 / 10 / 2
other
Total, other adverse events
11 / 4926 / 490 / 78 / 217 / 216 / 84 / 71 / 21 / 11 / 2
serious
Total, serious adverse events
0 / 490 / 491 / 73 / 210 / 213 / 80 / 71 / 20 / 10 / 2

Outcome results

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).

Time frame: Week 12

Population: All treated participants who have non-missing response at week 12

ArmMeasureValue (NUMBER)
Placebo Biologic NaivePercentage of Participants Who Achieve ASAS 20 at Week 1248.8 Percentage of Participants
CC-99677 60 mg Biologic NaivePercentage of Participants Who Achieve ASAS 20 at Week 1251.2 Percentage of Participants
CC-99677 150 mg Biologic NaivePercentage of Participants Who Achieve ASAS 20 at Week 1256.1 Percentage of Participants
Placebo Biologic FailurePercentage of Participants Who Achieve ASAS 20 at Week 1266.7 Percentage of Participants
CC-99677 60 mg Biologic FailurePercentage of Participants Who Achieve ASAS 20 at Week 1283.3 Percentage of Participants
CC-99677 150 mg Biologic FailurePercentage of Participants Who Achieve ASAS 20 at Week 1257.1 Percentage of Participants
p-value: 0.82995% CI: [-18.2, 22.7]Cochran-Mantel-Haenszel
p-value: 0.51295% CI: [-13.8, 27.5]Cochran-Mantel-Haenszel
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)

Time frame: Baseline and Week 12

Population: All treated participants with baseline and week 12 measurements

ArmMeasureValue (MEAN)Dispersion
Placebo Biologic NaiveChange From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12-0.69 Units on a scaleStandard Deviation 0.856
CC-99677 60 mg Biologic NaiveChange From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12-0.87 Units on a scaleStandard Deviation 0.681
CC-99677 150 mg Biologic NaiveChange From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12-0.80 Units on a scaleStandard Deviation 0.869
Placebo Biologic FailureChange From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12-0.84 Units on a scaleStandard Deviation 0.621
CC-99677 60 mg Biologic FailureChange From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12-1.02 Units on a scaleStandard Deviation 0.464
CC-99677 150 mg Biologic FailureChange From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12-0.44 Units on a scaleStandard Deviation 0.323
p-value: 0.29995% CI: [-0.5, 0.16]Longitudinal data analysis model
p-value: 0.48895% CI: [-0.45, 0.22]Longitudinal data analysis model
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.

Time frame: Baseline and Week 12

Population: All treated participants with baseline and week 12 measurements

ArmMeasureValue (MEAN)Dispersion
Placebo Biologic NaiveChange From Baseline in BASDAI at Week 12-1.88 Units on a scaleStandard Deviation 1.862
CC-99677 60 mg Biologic NaiveChange From Baseline in BASDAI at Week 12-1.96 Units on a scaleStandard Deviation 1.494
CC-99677 150 mg Biologic NaiveChange From Baseline in BASDAI at Week 12-2.03 Units on a scaleStandard Deviation 2.08
Placebo Biologic FailureChange From Baseline in BASDAI at Week 12-1.63 Units on a scaleStandard Deviation 0.651
CC-99677 60 mg Biologic FailureChange From Baseline in BASDAI at Week 12-2.20 Units on a scaleStandard Deviation 1.394
CC-99677 150 mg Biologic FailureChange From Baseline in BASDAI at Week 12-1.43 Units on a scaleStandard Deviation 1.517
p-value: 0.9795% CI: [-0.76, 0.79]Longitudinal data analysis model
p-value: 0.66895% CI: [-0.95, 0.61]Longitudinal data analysis model
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.

Time frame: Baseline and Week 12

Population: All treated participants with baseline and week 12 measurements

ArmMeasureValue (MEAN)Dispersion
Placebo Biologic NaiveChange From Baseline in BASFI at Week 12-1.22 Units on a scaleStandard Deviation 1.727
CC-99677 60 mg Biologic NaiveChange From Baseline in BASFI at Week 12-1.33 Units on a scaleStandard Deviation 1.985
CC-99677 150 mg Biologic NaiveChange From Baseline in BASFI at Week 12-1.28 Units on a scaleStandard Deviation 2.542
Placebo Biologic FailureChange From Baseline in BASFI at Week 12-1.77 Units on a scaleStandard Deviation 0.85
CC-99677 60 mg Biologic FailureChange From Baseline in BASFI at Week 12-1.47 Units on a scaleStandard Deviation 1.841
CC-99677 150 mg Biologic FailureChange From Baseline in BASFI at Week 12-1.29 Units on a scaleStandard Deviation 0.703
p-value: 0.8995% CI: [-0.77, 0.88]Longitudinal data analysis model
p-value: 0.54595% CI: [-0.57, 1.08]Longitudinal data analysis model
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.

Time frame: Baseline and Week 12

Population: All treated participants with baseline and week 12 measurements

ArmMeasureValue (MEAN)Dispersion
Placebo Biologic NaiveChange From Baseline in the SPARCC SI Joint Score at Week 120.25 Units on a scaleStandard Deviation 3.168
CC-99677 60 mg Biologic NaiveChange From Baseline in the SPARCC SI Joint Score at Week 12-0.81 Units on a scaleStandard Deviation 5.453
CC-99677 150 mg Biologic NaiveChange From Baseline in the SPARCC SI Joint Score at Week 12-1.72 Units on a scaleStandard Deviation 6.084
Placebo Biologic FailureChange From Baseline in the SPARCC SI Joint Score at Week 12-0.17 Units on a scaleStandard Deviation 1.258
CC-99677 60 mg Biologic FailureChange From Baseline in the SPARCC SI Joint Score at Week 12-3.00 Units on a scaleStandard Deviation 7.608
CC-99677 150 mg Biologic FailureChange From Baseline in the SPARCC SI Joint Score at Week 12-3.00 Units on a scaleStandard Deviation 4.093
p-value: 0.77895% CI: [-2.26, 1.7]Longitudinal data analysis model
p-value: 0.3395% CI: [-3.02, 1.03]Longitudinal data analysis model
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.

Time frame: Baseline and Week 12

Population: All treated participants with baseline and week 12 measurements

ArmMeasureValue (MEAN)Dispersion
Placebo Biologic NaiveChange From Baseline in the SPARCC Spine Score at Week 12-0.92 Units on a scaleStandard Deviation 7.557
CC-99677 60 mg Biologic NaiveChange From Baseline in the SPARCC Spine Score at Week 12-1.53 Units on a scaleStandard Deviation 8.331
CC-99677 150 mg Biologic NaiveChange From Baseline in the SPARCC Spine Score at Week 12-1.86 Units on a scaleStandard Deviation 7.081
Placebo Biologic FailureChange From Baseline in the SPARCC Spine Score at Week 12-8.17 Units on a scaleStandard Deviation 7.371
CC-99677 60 mg Biologic FailureChange From Baseline in the SPARCC Spine Score at Week 12-2.40 Units on a scaleStandard Deviation 5.128
CC-99677 150 mg Biologic FailureChange From Baseline in the SPARCC Spine Score at Week 12-2.71 Units on a scaleStandard Deviation 8.64
p-value: 0.695% CI: [-3.93, 2.28]Longitudinal data analysis model
p-value: 0.41695% CI: [-4.49, 1.87]Longitudinal data analysis model
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).

Time frame: Week 12

Population: All treated participants who have non-missing response at week 12

ArmMeasureValue (NUMBER)
Placebo Biologic NaivePercentage of Participants Who Achieve ASAS 40 at Week 1222.0 Percentage of Participants
CC-99677 60 mg Biologic NaivePercentage of Participants Who Achieve ASAS 40 at Week 1225.6 Percentage of Participants
CC-99677 150 mg Biologic NaivePercentage of Participants Who Achieve ASAS 40 at Week 1234.1 Percentage of Participants
Placebo Biologic FailurePercentage of Participants Who Achieve ASAS 40 at Week 1233.3 Percentage of Participants
CC-99677 60 mg Biologic FailurePercentage of Participants Who Achieve ASAS 40 at Week 1250.0 Percentage of Participants
CC-99677 150 mg Biologic FailurePercentage of Participants Who Achieve ASAS 40 at Week 1228.6 Percentage of Participants
p-value: 0.72595% CI: [-14.9, 21]Cochran-Mantel-Haenszel
p-value: 0.21995% CI: [-7.2, 30.5]Cochran-Mantel-Haenszel
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.

Time frame: Baseline and Week 12

Population: All treated participants with baseline and week 12 measurements

ArmMeasureValue (MEAN)Dispersion
Placebo Biologic NaivePercent Change From Baseline in hsCRP at Week 1272.83 Percent change in hsCRPStandard Deviation 474.199
CC-99677 60 mg Biologic NaivePercent Change From Baseline in hsCRP at Week 12-1.43 Percent change in hsCRPStandard Deviation 64.157
CC-99677 150 mg Biologic NaivePercent Change From Baseline in hsCRP at Week 1220.88 Percent change in hsCRPStandard Deviation 130.181
Placebo Biologic FailurePercent Change From Baseline in hsCRP at Week 12-13.68 Percent change in hsCRPStandard Deviation 55.618
CC-99677 60 mg Biologic FailurePercent Change From Baseline in hsCRP at Week 128.52 Percent change in hsCRPStandard Deviation 66.057
CC-99677 150 mg Biologic FailurePercent Change From Baseline in hsCRP at Week 12452.34 Percent change in hsCRPStandard Deviation 1226.664
95% CI: [-27.31, 14.79]
95% CI: [-36.57, -0.58]
95% CI: [-31.96, 7.65]

Source: ClinicalTrials.gov · Data processed: May 23, 2026