A phase 3 study of obexelimab in patients with warm autoimmune hemolytic anemia

Phase 3

• Conditions: Warm autoimmune hemolytic anemia; Haematological Disorders

• Registration Number: ISRCTN13110963
• Lead Sponsor: Zenas BioPharma (USA) LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-14
• Last Update Posted: 16 October 2023
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

PARTS A AND B: INCLUSION CRITERIA
1. Males and females, = 18 years of age
2. Clinically diagnosed with wAIHA for at least 3 months and currently receiving treatment for wAIHA or have previously received treatment for wAIHA.
3. Diagnosis of primary or secondary wAIHA documented by a positive direct antiglobulin test specific for anti-IgG or anti-IgA.
4. Failed at least 1 prior wAIHA treatment regimen.
5. At least one sign or symptom of anemia as assessed by the investigator at screening.
6. Other inclusion criteria apply.

Exclusion Criteria

PARTS A AND B: EXCLUSION CRITERIA
1. Have cold antibody AIHA, cold agglutinin syndrome, mixed type (i.e., warm, and cold) AIHA, or paroxysmal cold hemoglobinuria.
2. Have any other associated cause of hereditary or acquired hemolytic anemia.
3. For the RCP only, patients with secondary wAIHA not due to autoimmune disorders, including LPDs.
4. Received a transfusion within 2 weeks prior to randomisation.
5. Use of B cell-depleting, B cell-targeted, or other biologic immunomodulatory agents within the 6 months prior to randomisation.
6. Received IV Ig or epoetin alfa within 6 weeks prior to randomisation.
7. Receiving more than 2 concomitant medications for the treatment of wAIHA.
8. Other exclusion criteria apply.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Part A: Safety and Dose Confirmation Run-in Period (SRP)<br>1. Proportion of patients with Hgb = 10 g/dL and = 2 g/dL increase from Baseline on or after Week 8 with no use of blood transfusion or GC rescue therapy prior to attaining response<br><br>Part B: Randomised Control Period (RCP)<br>2. Proportion of patients who achieve a durable Hgb response (defined as Hgb = 10 g/dL and = 2 g/dL increase from Baseline on at least 3 of 4 consecutive available visits), at the earliest on or after Week 12, with no use of blood transfusion or GC rescue therapy prior to attaining durable response through Week 24<br>

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures