ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis
NCT ID: NCT04795141
Last Updated: 2023-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
25 participants
INTERVENTIONAL
2021-08-24
2022-08-30
Brief Summary
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Detailed Description
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The primary objective is to estimate the relationship between different dose regimens of ABY-035 and clinical response as assessed by Assessment of Spondyloarthritis International Society 40 (ASAS40) response at Week 16 in subjects with active AS.
The study will include the following 3 periods:
1. Screening Period: Up to 35 days prior to baseline randomization.
2. Treatment Period 1: Day 0-Week 16
Cohort 1: Eligible subjects will be randomized 1:1:1:1 to receive 1 of 4 treatments (ABY-035 High Dose every 2 weeks (Q2W), ABY-035 Low Dose every 2 weeks (Q2W), ABY-035 High Dose every 4 weeks (Q4W), or placebo Q2W), and will remain on their allowable background medication.
Cohort 2: Eligible subjects will be randomized 1:1:1 to receive 1 of 3 treatments (ABY-035 High Dose every week (QW), ABY-035 Low Dose every week (QW), or placebo QW), and will remain on their allowable background medication.
Randomization will be stratified by region (North Eastern Asia and North America) and previous tumor necrosis factor alpha (TNFα) inhibitor exposure (TNFα inhibitor treated or TNFα inhibitor naïve). Maximum 30% of subjects will be TNFα inhibitor-treated subjects to ensure a representative population for the assessment of efficacy and safety.
Treatment Period 1 ends at Week 16 after all trial assessments have been done and Treatment Period 2 starts at Week 16 with the IMP injection.
3. Treatment Period 2 (Extension Period): Week 16-Week 52 Cohort 1: Subjects will receive ABY-035 High Dose Q2W treatment in an open-label manner.
Cohort 2: Subjects will receive ABY-035 High Dose QW treatment in an open-label manner.
At Week24, subjects who could not achieve an ASAS20 response from baseline are defined as non-responders and will discontinue the study treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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#1: Cohort 1-High Dose Q2W
Cohort 1: ABY-035 High Dose, every 2 weeks, subcutaneous injection
ABY-035
ABY-035 Solution for injection
#2: Cohort 1-High Dose Q4W
Cohort 1: ABY-035 High Dose, every 4 weeks, subcutaneous injection
ABY-035
ABY-035 Solution for injection
#3: Cohort 1-Low Dose Q2W
Cohort 1: ABY-035 Low Dose, every 2 weeks, subcutaneous injection
ABY-035
ABY-035 Solution for injection
#4: Cohort 2-Low Dose QW
Cohort 2: ABY-035 Low Dose, every week, subcutaneous injection
ABY-035
ABY-035 Solution for injection
#5: Cohort 2-High Dose QW
Cohort 2: ABY-035 High Dose, every week, subcutaneous injection
ABY-035
ABY-035 Solution for injection
#1: Cohort 1-Placebo Q2W
Cohort 1: Placebo, every 2 weeks, subcutaneous injection
Placebo
Normal Saline for injection
#2: Cohort 2-Placebo QW
Cohort 2: Placebo, every week, subcutaneous injection
Placebo
Normal Saline for injection
Interventions
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ABY-035
ABY-035 Solution for injection
Placebo
Normal Saline for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects with active AS, determined by documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984).
AND At least one SpA feature, according to ASAS criteria.
3. Subjects have moderate to severe active disease
4. Subjects must have inadequate response or intolerance to at least 2 NSAIDs, or contraindication to NSAID therapy.
5. Subjects may be TNFα inhibitor-naïve or may have received up to 2 prior TNFα inhibitor(s)..
Exclusion Criteria
3. Subjects have received technetium-99 conjugated with methylene diphosphonate other than for diagnostic purpose within 5 years prior to baseline.
4. Have received any live (includes attenuated) vaccination within the 12 weeks prior to the baseline.
5. Subjects have received any non-biological therapy for AS not listed as detailed in the study protocol within or outside a clinical study in the 3 months or within 5 half-lives prior to the Baseline Visit (whichever is longer).
6. Subject has an active infection or history of infections
7. Have evidence of or test positive for hepatitis B virus (HBV)
8. Have evidence of or test positive for hepatitis C virus (HCV).
9. Have a historically positive human immunodeficiency virus (HIV) test or test positive at screening for HIV.
10. Subjects have known tuberculosis (TB) infection, at high risk of acquiring TB infection, or current or history of nontuberculous mycobacterium (NTMB) infection, or LTB.
11. Have a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
12. Subjects have active Crohn's disease (CD) or active ulcerative colitis (UC).
13. Subjects have active uveitis within 6 weeks prior to baseline.
14. Subjects have laboratory abnormalities at Screening.
18 Years
ALL
No
Sponsors
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Affibody
INDUSTRY
Inmagene LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Lawrence He
Role: STUDY_DIRECTOR
SVP, Global Regulatory Head
Locations
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Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, United States
Hope Clinical Research
Canoga Park, California, United States
Newport Huntington Medical Group
Huntington Beach, California, United States
Desert Medical Advances
Palm Desert, California, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States
Drucker Sarasota Arthritis Research Center
Sarasota, Florida, United States
Greater Chicago Specialty Physicians/ Clinical Investigation Specialists, Inc.
Schaumburg, Illinois, United States
Clinic of Robert Hozman, MD / Clinical Investigation Specialists,
Skokie, Illinois, United States
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
M3 Emerging Medical Research, LLC
Durham, North Carolina, United States
Clinical Research Source, Inc.
Perrysburg, Ohio, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
HRMD Research
Dallas, Texas, United States
Seattle Rheumatology Associates
Seattle, Washington, United States
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Chao-Yang Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tong Ji Hospital TongJi Medical Colleague of HUST
Wuhan, Hubei, China
Zhuzhou Hospital Affiliated to Xiangya School of Medicine
Zhuzhou, Hunan, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechNology
Baotou, Inner Mongolia, China
The Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Linyi People's Hospital
Linyi, Shandong, China
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Kaohsiung Chang Gung Memorial Hospital ，Chang Gung Medical Foundation
Gaoxiong, Taiwan, China
Kaohsiung Veterans General Hospital
Gaoxiong, Taiwan, China
National Taiwan University Hospital (NTUH)
Taibei, Taiwan, China
Tri-Service General Hospital
Taibei, Taiwan, China
China Medical University Hospital (CMUH)
Taizhong, Taiwan, China
Chung Shan Medical University Hospital (CSMHU)
Taizhong, Taiwan, China
The Affiliated Hospital of The Affiliated Hospital of Inner Mongolia Medical University Medical University
Hohhot, The Affiliated Hospital of Inner Mongolia Medical University, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Chonnam National University Hospital
Gwangju, Gwangju, South Korea
Ajou University Hospital
Gyeonggi-do, , South Korea
Bundang Seoul National University Hospital
Gyeonggi-do, , South Korea
Inha University Hospital
Incheon, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
Kyunghee University Hospital
Seoul, , South Korea
SNU Boramae Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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ABY-035-204
Identifier Type: -
Identifier Source: org_study_id
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