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

Spondylitis, Ankylosing Clinical Trial

— AS SpA axSpA  

Official title:

A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects With Active Ankylosing Spondylitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04947579
• Other study ID #: CC-99677-AS-001
• Secondary ID: U1111-1265-39512
• Status: Terminated
• Phase: Phase 2
• Start date: August 25, 2021
• Est. completion date: February 21, 2023

Study information

• Verified date: April 2024
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 information / eligibility

• Status: Terminated
• Enrollment: 167
• Est. completion date: February 21, 2023
• Est. primary completion date: February 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• CC-99677
Oral

Other:
• Placebo
Oral

Locations

Country	Name	City	State
China	Local Institution - 151	Guangzhou
China	Local Institution - 152	Hangzhou
China	Local Institution - 153	Huangpu District
China	Local Institution - 154	Shanghai	Shanghai
China	Local Institution - 150	Wuhan
Czechia	Local Institution - 205	Brno
Czechia	Local Institution - 206	Ostrava
Czechia	Local Institution - 207	Ostrava
Czechia	Local Institution - 201	Pardubice
Czechia	Local Institution - 211	Praha 11
Czechia	Local Institution - 202	Praha 3
Czechia	Local Institution - 203	Praha 4
Czechia	Local Institution - 204	Uherské Hradište
Germany	Local Institution - 900	Herne
Poland	Local Institution - 311	Bialystok
Poland	Local Institution - 315	Bialystok
Poland	Local Institution - 302	Bydgoszcz
Poland	Local Institution - 305	Bydgoszcz
Poland	Local Institution - 301	Elblag
Poland	Local Institution - 307	Katowice
Poland	Local Institution - 300	Krakow
Poland	Local Institution - 308	Krakow
Poland	Local Institution - 310	Nowa Sol
Poland	Local Institution - 313	Onyksowa 10
Poland	Local Institution - 312	Sochaczew
Poland	Local Institution - 306	Torun
Poland	Local Institution - 303	Warsaw
Poland	Local Institution - 309	Wroclaw
Romania	Local Institution - 400	Brasov
Romania	Local Institution - 402	Bucuresti
Romania	Local Institution - 403	Bucuresti
Romania	Local Institution - 404	Bucuresti
Spain	Local Institution - 604	A Coruña
Spain	Local Institution - 607	Barcelona
Spain	Local Institution - 606	Cordoba
Spain	Local Institution - 605	Merida
Spain	Local Institution - 601	Sabadell
Spain	Local Institution - 602	Santiago De Compostela
Spain	Local Institution - 603	Sevilla
Turkey	Local Institution - 702	Adapazari
Turkey	Local Institution - 707	Altindag/Ankara
Turkey	Local Institution - 700	Ankara
Turkey	Local Institution - 701	Edirne
Turkey	Local Institution - 705	Istanbul
Turkey	Local Institution - 706	Izmir
Turkey	Local Institution - 704	Karabaglar
Turkey	Local Institution - 703	Trabzon
United States	Local Institution - 029	Austin	Texas
United States	Local Institution - 028	Cleveland	Ohio
United States	Local Institution - 006	Colleyville	Texas
United States	Local Institution - 004	Dayton	Ohio
United States	Local Institution - 003	Duncansville	Pennsylvania
United States	Local Institution - 024	Flagstaff	Arizona
United States	Local Institution - 019	Fort Worth	Texas
United States	Local Institution - 021	Gilbert	Arizona
United States	Local Institution - 008	Houston	Texas
United States	Local Institution - 005	Jackson	Tennessee
United States	Local Institution - 002	Memphis	Tennessee
United States	Local Institution - 022	Phoenix	Arizona
United States	Local Institution - 009	Portland	Oregon
United States	Local Institution - 026	Saint Clair Shores	Michigan
United States	Local Institution - 025	Tucson	Arizona
United States	Local Institution - 017	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  China,  Czechia,  Germany,  Poland,  Romania,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieve ASAS 20 at Week 12	Percentage of participants who achieve an improvement in disease activity from baseline of = 20% and = 1 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening from baseline of = 20% and = 1 unit in the remaining domain on a scale of 0 to 10. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are: Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale [NRS]); Total Back Pain NRS; Function (the Bath Ankylosing Spondylitis Functional Index [BASFI] score NRS); Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] NRS Questions #5 and #6 for morning stiffness).	Week 12
Secondary	Percentage of Participants Who Achieve ASAS 40 at Week 12	Percentage of participants who achieve an improvement in disease activity from baseline of = 40% and = 2 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening at all from baseline in the remaining domain. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are: Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale [NRS]); Total Back Pain NRS; Function (the Bath Ankylosing Spondylitis Functional Index [BASFI] score NRS); Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] NRS Questions #5 and #6 for morning stiffness).	Week 12
Secondary	Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12	ASDAS-CRP is a score of disease activity that combines patient reported assessments of back pain (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] question 2), duration of morning stiffness (BASDAI question 6), peripheral joint pain and/or swelling (BASDAI question 3), general wellbeing, and CRP in a weighted manner. The cut-off values for disease activity states and improvement scores are defined as follows: <1.3 inactive disease, =1.3 and <2.1 low disease activity, =2.1 and =3.5 high disease activity and 3.5 very high disease activity. The minimum clinically important difference (MCID) are defined as: change of at least 1.1 unit for 'clinically important improvement' and change of at least 2.0 units for 'major improvement'. Baseline is the last non-missing value on or before the date of the first dose of investigational product. ASDAS-CRP Formula: 0.12xBack Pain+0.06xDuration of Morning Stiffness+0.11xPatient Global+0.07xPeripheral Pain/Swelling+0.58xln(CRP+1)	Baseline and Week 12
Secondary	Change From Baseline in BASDAI at Week 12	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a composite score based on a self-administered survey of six questions using a 0 to 10 unit numerical rating scale (NRS) that assesses five major symptoms of AS during the last week: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater is considered to be indicative of active AS disease. Baseline is the last non-missing value on or before the date of the first dose of investigational product.	Baseline and Week 12
Secondary	Change From Baseline in BASFI at Week 12	Bath Ankylosing Spondylitis Functional Index (BASFI) is a composite score based on a self administered survey of ten questions using a 0 to 10 unit numerical rating scale (NRS) that assesses degree of mobility and functional ability during the last week. The questionnaire consists of eight questions regarding function in AS and the two last questions reflecting ability to cope with everyday life. The left-hand box of 0 represents "easy," and the right-hand box represents "impossible." The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. A higher BASFI score correlates to reduced functional ability. Baseline is the last non-missing value on or before the date of the first dose of investigational product.	Baseline and Week 12
Secondary	Change From Baseline in the SPARCC SI Joint Score at Week 12	Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the sacroiliac joints. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. Baseline is the last non-missing value on or before the date of the first dose of investigational product.	Baseline and Week 12
Secondary	Change From Baseline in the SPARCC Spine Score at Week 12	Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the total spine. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) were scored for bone marrow edema. A single DVU has 18 scoring units, and each has score of 0 or 1, bringing the maximum total score to 414, the sum ranges from 0 to 414 with higher scores reflecting worse disease.; Baseline is the last non-missing value on or before the date of the first dose of investigational product.	Baseline and Week 12
Secondary	Percent Change From Baseline in hsCRP at Week 12	Percent change from baseline in high-sensitivity C-reactive protein (hsCRP). Baseline is the last non-missing value on or before the date of the first dose of investigational product.	Baseline and Week 12

External Links

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