Ankylosing Spondylitis MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Code: CC-99677 60mg Capsule
Pharmaceutical Form: Capsule
INN or Proposed INN: 146368
CAS Number: 1887069-10-4
Current Sponsor code: CC-99677
Other descriptive name: CC-99677
Concentration unit
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of AS fulfilling the modified New York criteria - Active axial disease defined by a BASDAI score = 4 and Total Back Pain = 4 - Failed prior treatment with at least 2 NSAIDs for at least 4 weeks each - Subject has never received a biologic therapy for the treatment of AS, or have taken more than one biologic therapy - Concomitant use of sulfasalazine is permitted provided it is used at a stable dose for at least 4 weeks prior to Baseline (Day 1 of study) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 256 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -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 JAK inhibitors, cell depleting biologic agents -Participation in any study of an investigational drug, including those for COVID-19 -History of malignancy -Oral corticosteroids > 10 mg/day for = 2 weeks prior to Baseline Visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the dose dependent efficacy of oral CC-99677, administered every day (QD) compared to placebo, as determined by the attainment of the Assessment in SpondyloArthritis International Society Response Criteria (ASAS 20) after 12 weeks of treatment, in subjects with radiologically confirmed AS and inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).;Secondary Objective: To evaluate the effects of oral CC-99677, administered QD, compared to placebo, after 12 weeks of treatment in subjects with AS, on: - The signs and symptoms of AS, as assessed by attainment of Assessment in SpondyloArthritis International Society 40% Response Criteria (ASAS 40), a composite measure of clinical improvement in axial spondyloarthritis, Ankylosing Spondylitis Disease Activity Score (ASDAS) with C-reactive protein (CRP) as the acute-phase reactant (ASDAS-CRP), and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) - Measures of physical function, as assessed by Bath Ankylosing Spondylitis Functional Index (BASFI) - Spinal and sacroiliac joint inflammation as measured by Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) score of sacroiliac joints and spine -Percent change from baseline in high-sensitivity C-reactive protein (hsCRP) - Safety and tolerability;Primary end point(s): ASAS 20: Proportion of subjects who achieve an improvement in disease activity from baseline of = 20% and = 1 unit in at least 3 of the 4 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 ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. ASAS40 2. ASDAS-CRP 3. BASDAI 4. BASFI 5. MRI SPARCC scores of the total spine and of the sacroiliac joints 6. Percent change from baseline in high-sensitivity C-reactive protein (hsCRP) 7. Safety and tolerability ;Timepoint(s) of evaluation of this end point: All at Week 12; except Safety and tolerability which is from signing of informed consent form through 4 week post-treatment observational follow-up period. | — |
Countries
Canada, Czechia, Czech Republic, Germany, Poland, Romania, Russian Federation, Spain, Turkey, United States
Contacts
Public ContactGSM-CT
Bristol-Meyers Squibb International Corporation
Outcome results
None listed