ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    300
  • sponsor
    Inmagene Biopharmaceuticals
Updated on 5 April 2022
x-rays
NSAID

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.

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 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 Eligible subjects will be randomized 1:1:1:1 to receive 1 of 4 treatments (ABY-035 80 mg Q2W, ABY-035 160 mg Q4W, ABY-035 40 mg Q2W, or placebo), 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 Subjects will continue their original treatment of Treatment Period 1 in a double-blinded manner.

Subjects who couldn't achieve an ASAS20 response from baseline are defined as non-responders and eligible for rescue treatment after Week 16 (Visit 9).

Details
Condition Ankylosing Spondylitis
Treatment Normal saline, ABY-035
Clinical Study IdentifierNCT04795141
SponsorInmagene Biopharmaceuticals
Last Modified on5 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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