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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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment until at least 28 days after completion of study treatment
Awards & highlights

AS SpA axSpA Trial Summary

This trial will study the effects of CC-99677 on patients with Ankylosing Spondylitis over 12 weeks, measuring symptoms, disease activity, quality of life, safety, and tolerability.

Eligible Conditions
  • Ankylosing Spondylitis

AS SpA axSpA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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A person has spondylitis if their BASDAI score is ≥ 4 and their total back pain is ≥ 4.
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The person has tried taking at least two different types of NSAIDs (non-steroidal anti-inflammatory drugs) for a total of at least four weeks, but their pain has not improved.
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The study participant has never received a biologic therapy, such as a tumor necrosis factor (TNF) antagonist or a monoclonal antibody (mAb) against interleukin-17 (IL-17), for the treatment of ankylosing spondylitis (AS)

AS SpA axSpA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment until at least 28 days after completion of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment until at least 28 days after completion of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of ASAS 20
Secondary outcome measures
Assessment of ASAS 40
Assessment of ASDAS-CRP
Assessment of BASDAI
+4 more

AS SpA axSpA 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
632 Previous Clinical Trials
127,753 Total Patients Enrolled
Robert Wong, MDStudy DirectorCelgene Corporation
1 Previous Clinical Trials
185 Total Patients Enrolled
Bristol-Myers Squibb, MDStudy DirectorBristol-Myers Squibb
1 Previous Clinical Trials
911 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does CC-99677 have a high potential for patient harm?

"There is some data suggesting that CC-99677 is safe, but none yet to support its efficacy. For this reason, it received a score of 2."

Answered by AI

Are there different research facilities testing this medication in our state?

"In total, there are 22 different locations where patients can enroll in this trial. Some notable places include Pioneer Research Solutions in Cypress, Austin Regional Clinic in Austin, and Altoona Center For Clinical Research in Duncansville."

Answered by AI

Are there any current openings in this research project for new participants?

"That is correct, the clinical trial listed on clinicaltrials.gov is searching for more participants. The study was first posted on 8/25/2021 and has been updated as recently as 11/17/2022. Right now, 22 locations are enrolling a total of 256 people."

Answered by AI

Will this research project be studying individuals who are over 35 years old?

"The age range for patients that are being recruited for this trial are individuals who have not yet reached their 65th birthday but are 18 years old or older."

Answered by AI

Who meets the qualifications to participate in this research project?

"This trial is open to 256 patients aged 18-65 who currently have spondylitis or ankylosing. Patients must also meet the following criteria: 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-fail"

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
Arizona
Oregon
Other
How old are they?
18 - 65
What site did they apply to?
West Tennessee Research Institute
Arizona Arthritis & Rheumatology Research, PLLC - Gilbert
Arizona Arthritis & Rheumatology Research, PLLC - Phoenix
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+

Why did patients apply to this trial?

I've tried tylenol, advil, meloxicam. no help. looking for other resources.
PatientReceived 1 prior treatment
I have tried at least three different drugs for my condition and it had not worked. I have tried PT, Cupping, acupuncture, inflammation medication and so much more. I am really hoping a clinical trial can help me with a treatment.
PatientReceived no prior treatments
~47 spots leftby Mar 2025