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CC-99677 for Ankylosing Spondylitis (AS SpA axSpA Trial)
Phase 2
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Summary
This trial is testing a new medication called CC-99677 to see if it helps people with Ankylosing Spondylitis (AS). The study will measure changes in symptoms, disease activity, and quality of life over a few months. The goal is to find out if this medication can reduce pain and inflammation, making it easier for patients to move and feel better.
Eligible Conditions
- Ankylosing Spondylitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Who Achieve ASAS 20 at Week 12
Secondary study objectives
Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12
Change From Baseline in BASDAI at Week 12
Change From Baseline in BASFI at Week 12
+4 moreTrial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Administration of CC-99677 60mg QD PO.Experimental Treatment1 Intervention
20 participants will be randomized to CC-99677 60 mg in biologic-failure substudy
Group II: Administration of CC-99677 60mg QD POExperimental Treatment1 Intervention
49 participants will be randomized to CC-99677 60 mg in biologic naive main study
Group III: Administration of CC-99677 150 mg QD PO.Experimental Treatment1 Intervention
20 participants will be randomized to CC-99677 150 mg in biologic-failure substudy
Group IV: Administration of CC-99677 150 mg QD POExperimental Treatment1 Intervention
49 participants will be randomized to CC-99677 150 mg in biologic naive main study
Group V: Placebo additional dose cohortPlacebo Group1 Intervention
10 participants will be randomized to placebo in biologic-failure substudy
Group VI: Administration of Placebo QD POPlacebo Group1 Intervention
49 participants will be randomized to placebo in biologic naive main study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-99677
2020
Completed Phase 1
~210
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
645 Previous Clinical Trials
130,265 Total Patients Enrolled
Robert Wong, MDStudy DirectorCelgene Corporation
1 Previous Clinical Trials
185 Total Patients Enrolled
Bristol-Myers Squibb, MDStudy DirectorBristol-Myers Squibb
2 Previous Clinical Trials
1,491 Total Patients Enrolled
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