A Study of CC-99677 in Participants With Active Ankylosing Spondylitis (AS SpA axSpA)

Celgene

Status and phase: Terminated; Phase 2

Conditions: Spondylitis, Ankylosing

Treatments: Other: Placebo; Drug: CC-99677

Study type: Interventional

Funder types: Industry

Identifiers

NCT04947579

U1111-1265-3951 (Registry Identifier)

CC-99677-AS-001

2019-004108-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 167 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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167 participants in 6 patient groups, including a placebo group

Administration of CC-99677 150 mg QD PO

Experimental group

Description:

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

Treatment:

Drug: CC-99677

Administration of CC-99677 60mg QD PO

Experimental group

Description:

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

Treatment:

Drug: CC-99677

Administration of Placebo QD PO

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Administration of CC-99677 150 mg QD PO.

Experimental group

Description:

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

Treatment:

Drug: CC-99677

Administration of CC-99677 60mg QD PO.

Experimental group

Description:

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

Treatment:

Drug: CC-99677

Placebo additional dose cohort

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo