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A Study of CC-99677 in Participants With Active 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 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

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 more

Trial 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
130,016 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
~39 spots leftby Dec 2025
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