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ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis

NCT04795141 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-07-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ABY-035

ABY-035 Solution for injection

DRUG

Placebo

Normal Saline for injection

Sponsors & Collaborators

  • Affibody

    collaborator INDUSTRY

  • Inmagene LLC

    lead INDUSTRY

Principal Investigators

  • Lawrence He · SVP, Global Regulatory Head

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-24
Primary Completion
2022-07-11
Completion
2022-08-30
FDA Drug
Yes

Countries

  • United States
  • China
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04795141 on ClinicalTrials.gov