Study Stopped
The sponsor's development strategy is adjusted.
ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis
1 other identifier
interventional
25
3 countries
47
Brief Summary
ABY-035-204 is a clinical study to assess the efficacy of IL-17 blocker ABY-035 in ankylosing spondylitis(AS). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2021
Shorter than P25 for phase_2
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2021
CompletedFirst Posted
Study publicly available on registry
March 12, 2021
CompletedStudy Start
First participant enrolled
August 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2022
CompletedJuly 12, 2023
July 1, 2023
11 months
March 3, 2021
July 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects achieving an ASAS40 response
The treatment effect
16 weeks
Secondary Outcomes (13)
Change from baseline in BASDAI
16 weeks
Change from baseline in BASFI
16 weeks
Proportion of subjects reaching ASDAS-MI
16 weeks
Incidence of AEs
74 weeks
Incidence of serious adverse events (SAEs) and adverse events of special interests (AESIs)
74 weeks
- +8 more secondary outcomes
Study Arms (7)
#1: Cohort 1-High Dose Q2W
EXPERIMENTALCohort 1: ABY-035 High Dose, every 2 weeks, subcutaneous injection
#2: Cohort 1-High Dose Q4W
EXPERIMENTALCohort 1: ABY-035 High Dose, every 4 weeks, subcutaneous injection
#3: Cohort 1-Low Dose Q2W
EXPERIMENTALCohort 1: ABY-035 Low Dose, every 2 weeks, subcutaneous injection
#4: Cohort 2-Low Dose QW
EXPERIMENTALCohort 2: ABY-035 Low Dose, every week, subcutaneous injection
#5: Cohort 2-High Dose QW
EXPERIMENTALCohort 2: ABY-035 High Dose, every week, subcutaneous injection
#1: Cohort 1-Placebo Q2W
PLACEBO COMPARATORCohort 1: Placebo, every 2 weeks, subcutaneous injection
#2: Cohort 2-Placebo QW
PLACEBO COMPARATORCohort 2: Placebo, every week, subcutaneous injection
Interventions
ABY-035 Solution for injection
Normal Saline for injection
Eligibility Criteria
You may qualify if:
- Male or female at least 18 years of age.
- 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.
- Subjects have moderate to severe active disease
- Subjects must have inadequate response or intolerance to at least 2 NSAIDs, or contraindication to NSAID therapy.
- Subjects may be TNFα inhibitor-naïve or may have received up to 2 prior TNFα inhibitor(s)..
You may not qualify if:
- Subjects have active fibromyalgia or total spinal ankylosis ('bamboo spine'), or any other inflammatory arthritis.
- Subjects have received technetium-99 conjugated with methylene diphosphonate other than for diagnostic purpose within 5 years prior to baseline.
- Have received any live (includes attenuated) vaccination within the 12 weeks prior to the baseline.
- 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).
- Subject has an active infection or history of infections
- Have evidence of or test positive for hepatitis B virus (HBV)
- Have evidence of or test positive for hepatitis C virus (HCV).
- Have a historically positive human immunodeficiency virus (HIV) test or test positive at screening for HIV.
- Subjects have known tuberculosis (TB) infection, at high risk of acquiring TB infection, or current or history of nontuberculous mycobacterium (NTMB) infection, or LTB.
- Have a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
- Subjects have active Crohn's disease (CD) or active ulcerative colitis (UC).
- Subjects have active uveitis within 6 weeks prior to baseline.
- Subjects have laboratory abnormalities at Screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inmagene LLClead
- Affibodycollaborator
Study Sites (47)
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, 85306, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
Newport Huntington Medical Group
Huntington Beach, California, 92648, United States
Desert Medical Advances
Palm Desert, California, 92260, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, 33180, United States
Drucker Sarasota Arthritis Research Center
Sarasota, Florida, 34293, United States
Greater Chicago Specialty Physicians/ Clinical Investigation Specialists, Inc.
Schaumburg, Illinois, 60195, United States
Clinic of Robert Hozman, MD / Clinical Investigation Specialists,
Skokie, Illinois, 60076, United States
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, 21740, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
M3 Emerging Medical Research, LLC
Durham, North Carolina, 27704, United States
Clinical Research Source, Inc.
Perrysburg, Ohio, 43551, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
HRMD Research
Dallas, Texas, 75240, United States
Seattle Rheumatology Associates
Seattle, Washington, 98122, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lawrence He
SVP, Global Regulatory Head
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2021
First Posted
March 12, 2021
Study Start
August 24, 2021
Primary Completion
July 11, 2022
Study Completion
August 30, 2022
Last Updated
July 12, 2023
Record last verified: 2023-07