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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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