ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Ankylosing Spondylitis

In brief

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.

Key facts

Study ID

NCT04795141

Run by

Inmagene LLC

People needed

25

Starts

2021-08-24

Expected to finish

2022-08-30

Last updated by the study team

2023-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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 used medications in the manner as detailed by the exclusion criteria as detailed in the study protocol.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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