NCT05786573

Brief Summary

This study aims to examine the efficacy and safety of obexelimab in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P25-P50 for phase_3

Timeline
4mo left

Started Sep 2023

Typical duration for phase_3

Geographic Reach
5 countries

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Sep 2023Aug 2026

First Submitted

Initial submission to the registry

March 13, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

September 25, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

2.8 years

First QC Date

March 13, 2023

Last Update Submit

June 23, 2025

Conditions

Warm Autoimmune Hemolytic Anemia

Keywords

Warm Autoimmune Hemolytic AnemiawAIHA

Outcome Measures

Primary Outcomes (2)

  • Safety and Dose Confirmation Run-in Period (SRP)

    Proportion of participants with hemoglobin (Hgb) ≥ 10 g/dL and ≥ 2 g/dL increase from Baseline with no use of blood transfusion or glucocorticoid (GC) rescue therapy.

    24 weeks

  • Randomized Control Period (RCP)

    Proportion of participants 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.

    24 weeks

Study Arms (3)

Safety and Dose Confirmation Run-in Period (SRP): Obexelimab

EXPERIMENTAL

Obexelimab will be administered as an SC injection for 24 weeks.

Drug: Obexelimab

Randomized Control Period (RCP): Obexelimab

EXPERIMENTAL

Obexelimab will be administered as an SC injection for 24 weeks.

Drug: Obexelimab

Randomized Control Period (RCP): Placebo

PLACEBO COMPARATOR

Placebo will be administered as an SC injection for 24 weeks

Other: Placebo

Interventions

ObexelimabDRUG

Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcγRIIb, resulting in down regulation of B cell activity.

Safety and Dose Confirmation Run-in Period (SRP): Obexelimab
PlaceboOTHER

Placebo

Randomized Control Period (RCP): Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females, ≥ 18 years of age
  • Clinically diagnosed with wAIHA for at least 3 months and currently receiving treatment for wAIHA or have previously received treatment for wAIHA.
  • Diagnosis of primary or secondary wAIHA documented by a positive direct antiglobulin test specific for anti-IgG or anti-IgA.
  • Failed at least 1 prior wAIHA treatment regimen.
  • At least one sign or symptom of anemia as assessed by the investigator at screening.

You may not qualify if:

  • Have cold antibody AIHA, cold agglutinin syndrome, mixed type (i.e., warm, and cold) AIHA, or paroxysmal cold hemoglobinuria.
  • Have any other associated cause of hereditary or acquired hemolytic anemia.
  • For the RCP only, patients with secondary wAIHA not due to autoimmune disorders, including LPDs.
  • Received a transfusion within 2 weeks prior to randomization.
  • Use of B cell-depleting, B cell-targeted, or other biologic immunomodulatory agents within the 6 months prior to randomization.
  • Received IV Ig or epoetin alfa within 6 weeks prior to randomization.
  • Receiving more than 2 concomitant medications for the treatment of wAIHA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii

Gdansk, Pomeranian Voivodeship, 80-219, Poland

Location

Hospital Universitario de Burgos

Burgos, 9006, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, Kent, CT1 3NG, United Kingdom

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2023

First Posted

March 27, 2023

Study Start

September 25, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

June 25, 2025

Record last verified: 2025-06

Locations

IT(1)ES(2)TW(1)PL(1)GB(2)