ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis

• Status: Not yet recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inmagene Biopharmaceuticals
• Collaborator: Affibody

Criteria

Inclusion Criteria:

1. Male or female at least 18 years of age.

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:

1. Subjects have active fibromyalgia or total spinal ankylosis ('bamboo spine'), or any other inflammatory arthritis.

2. Subjects have used medications in the manner as detailed by the exclusion criteria as detailed in the study protocol.

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.