Status:
TERMINATED
ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis
Lead Sponsor:
Inmagene LLC
Collaborating Sponsors:
Affibody
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Detailed Description
ABY-035-204 is a double-blind, randomized, parallel-group, placebo-controlled study. The primary objective is to estimate the relationship between different dose regimens of ABY-035 and clinical resp...
Eligibility Criteria
Inclusion
- 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)..
Exclusion
- 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.
Key Trial Info
Start Date :
August 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04795141
Start Date
August 24 2021
End Date
August 30 2022
Last Update
July 12 2023
Active Locations (47)
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1
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, United States, 85306
2
Hope Clinical Research
Canoga Park, California, United States, 91303
3
Newport Huntington Medical Group
Huntington Beach, California, United States, 92648
4
Desert Medical Advances
Palm Desert, California, United States, 92260