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A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)

Primary Purpose

Warm Autoimmune Hemolytic Anemia

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Obexelimab
Obexelimab
Placebo
Sponsored by
Zenas BioPharma (USA), LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Warm Autoimmune Hemolytic Anemia focused on measuring Warm Autoimmune Hemolytic Anemia, wAIHA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Other inclusion criteria apply. Exclusion Criteria: 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. Other exclusion criteria apply.

Sites / Locations

  • Integris Southwest Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

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

Randomized Control Period (RCP): Obexelimab

Randomized Control Period (RCP): Placebo

Arm Description

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

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

Placebo will be administered as an SC injection for 24 weeks

Outcomes

Primary Outcome Measures

1. 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.
2. 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.

Secondary Outcome Measures

Full Information

First Posted
March 13, 2023
Last Updated
August 15, 2023
Sponsor
Zenas BioPharma (USA), LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05786573
Brief Title
A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With An Open Label Safety and Dose Confirmation Run-In Period, To Evaluate the Efficacy and Safety of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zenas BioPharma (USA), LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to examine the efficacy and safety of obexelimab in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
Detailed Description
This study consists of a 6-month open label Safety and Dose Confirmation Run-in Period (SRP), 6-month Randomized Control Period (RCP), and an additional 1-year open-label extension (OLE) period. To enter the Screening Period (Day -28 to Day -1) in the SRP or RCP, patients must have a clinical diagnosis of primary or secondary wAIHA due to an underlying autoimmune disorder, have failed at least 1 prior wAIHA treatment regimen, and have a Hgb level of ≥ 7 to < 10 g/dL with at least one sign or symptom of anemia. For the SRP only, patients with secondary wAIHA due to underlying lymphoproliferative disease may be eligible if they are receiving stable treatment. All patients in the SRP or RCP are allowed to continue up to 2 failed wAIHA therapies throughout the 24-week study. On Day 1 of the SRP, patients receive obexelimab administered as subcutaneous (SC) injections. On Day 1 of the RCP, patients will be randomized in a ratio of 1:1 to receive either obexelimab or placebo administered as subcutaneous (SC) injections. Patients must return to the study site for the first 5 weeks and then every 2 weeks thereafter. Patients will undergo assessments for efficacy, safety, PK, PD, and immunogenicity during the 24-week SRP or RCP. Following the 24-week SRP or RCP, patients will have the opportunity to receive obexelimab for up to 52 weeks in the Open Label Extension (OLE) Period. Including screening and follow-up, the maximum duration of participation in this study for an individual patient is 81 weeks (i.e., 28-day screening, 24-week SRP or RCP, 52-week OLE, and an 8-week follow-up).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warm Autoimmune Hemolytic Anemia
Keywords
Warm Autoimmune Hemolytic Anemia, wAIHA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Safety and Dose Confirmation Run-in Period (SRP): Obexelimab
Arm Type
Experimental
Arm Description
Obexelimab will be administered as an SC injection for 24 weeks.
Arm Title
Randomized Control Period (RCP): Obexelimab
Arm Type
Experimental
Arm Description
Obexelimab will be administered as an SC injection for 24 weeks.
Arm Title
Randomized Control Period (RCP): Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered as an SC injection for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Obexelimab
Intervention Description
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcγRIIb, resulting in down regulation of B cell activity.
Intervention Type
Drug
Intervention Name(s)
Obexelimab
Intervention Description
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcγRIIb, resulting in down regulation of B cell activity.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
1. Safety and Dose Confirmation Run-in Period (SRP)
Description
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.
Time Frame
24 weeks
Title
2. Randomized Control Period (RCP)
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Other inclusion criteria apply. Exclusion Criteria: 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. Other exclusion criteria apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patient and Medical Information
Phone
833-269-4696
Email
clinicaltrialsinfo@zenasbio.com
Facility Information:
Facility Name
Integris Southwest Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)

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