Clinical Trials in the UK / NCT05786573
Active, not recruiting
Phase 3
A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)
NCT05786573 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Warm Autoimmune Hemolytic Anemia
Investigational drug(s) / intervention(s)
Obexelimab: Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcγRIIb, resulting in down regulation of B cell activity.
Obexelimab: Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcγRIIb, resulting in down regulation of B cell activity.
Placebo: Placebo
Study summary
This study aims to examine the efficacy and safety of obexelimab in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
Eligibility
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:
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 randomization.
5. Use of B cell-depleting, B cell-targeted, or other biologic immunomodulatory agents within the 6 months prior to randomization.
6. Received IV Ig or epoetin alfa within 6 weeks prior to randomization.
7. Receiving more than 2 concomitant medications for the treatment of wAIHA.
8. Other exclusion criteria apply.
Primary outcome measure(s)
- Safety and Dose Confirmation Run-in Period (SRP) — 24 weeks
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. - Randomized Control Period (RCP) — 24 weeks
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.
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | Italy | |
| Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii | Gdansk | Pomeranian Voivodeship | |
| Hospital Universitario de Burgos | Burgos | Spain | |
| Hospital Universitario 12 de Octubre | Madrid | Spain | |
| National Cheng Kung University Hospital | Tainan | Taiwan | |
| Plymouth Hospitals NHS Trust | Plymouth | Devon | |
| Kent and Canterbury Hospital | Canterbury | Kent |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05786573 on ClinicalTrials.gov ↗ ← All trials in the UK