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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04947579
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Celgene
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bristol-Myers Squibb, MD
Principal Investigator Affiliation	Bristol-Myers Squibb
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, China, Czechia, Germany, Poland, Romania, Russian Federation, Spain, Turkey, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spondylitis, Ankylosing
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Administration of CC-99677 150 mg QD PO

49 participants will be randomized to CC-99677 150 mg in biologic naive main study

Experimental: Administration of CC-99677 60mg QD PO

49 participants will be randomized to CC-99677 60 mg in biologic naive main study

Placebo Comparator: Administration of Placebo QD PO

49 participants will be randomized to placebo in biologic naive main study

Experimental: Administration of CC-99677 150 mg QD PO.

20 participants will be randomized to CC-99677 150 mg in biologic-failure substudy

Experimental: Administration of CC-99677 60mg QD PO.

20 participants will be randomized to CC-99677 60 mg in biologic-failure substudy

Placebo Comparator: Placebo additional dose cohort

10 participants will be randomized to placebo in biologic-failure substudy

Interventions

Drug: - CC-99677

Oral

Other: - Placebo

Oral

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Flagstaff, Arizona

Status

Not yet recruiting

Address

Arizona Arthritis & Rheumatology Research - Flagstaff

Flagstaff, Arizona, 86001

Site Contact

Clinical Trial Finder