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

April 4, 2024 updated by: Zenas BioPharma (USA), LLC

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

134

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milano, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Torino, Italy, 10126
        • Recruiting
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italy, 33100
        • Not yet recruiting
        • Azienda Sanitaria Universitaria Giuliano Isontina
    • Piemonte
      • Novara, Piemonte, Italy, 28100
        • Recruiting
        • A.O.U. Maggiore della Carità
  • Japan
      • Fukushima, Japan, 960-1295
        • Recruiting
        • Fukushima Medical University Hospital
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital
    • Hukuoka
      • Kitakyushu, Hukuoka, Japan, 807-8556
        • Recruiting
        • Hospital of the University of Occupational & Environmental Health
    • Hyogo
      • Himeji, Hyogo, Japan, 670-8540
        • Recruiting
        • Japanese Red Cross Society Himeji Hospital
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, 252-0329
        • Not yet recruiting
        • Kitasato University Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Not yet recruiting
        • Osaka University Hospital
  • Poland
      • Gdańsk, Poland, 80-214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne - Ul. Smoluchowskiego 17
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-219
        • Recruiting
        • Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii
    • Warminsko-mazurskie
      • Olsztyn, Warminsko-mazurskie, Poland, 10-228
        • Recruiting
        • SPZOZ MiSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
  • Spain
      • Burgos, Spain, 9006
        • Recruiting
        • Hospital Universitario de Burgos
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de octubre
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio - PPDS
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital Universitario Germans Trias i Pujol
    • Las Palmas
      • Las Palmas De Gran Canaria, Las Palmas, Spain, 35010
        • Recruiting
        • Hospital Universitario de Gran Canaria Doctor Negrín
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Hospital Universitario de Navarra
  • Taiwan
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
      • Tainan, Taiwan, 736
        • Recruiting
        • Chi Mei Medical Center, Liouying
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital
    • Changhua
      • Chang Hua, Changhua, Taiwan, 500
        • Recruiting
        • Changhua Christian Hospital
  • Turkey
      • Ankara, Turkey
        • Not yet recruiting
        • Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi
      • Samsun, Turkey, 55139
        • Not yet recruiting
        • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
      • Tekirdağ, Turkey, 59100
        • Not yet recruiting
        • Namik Kemal University
      • Trabzon, Turkey, 61080
        • Not yet recruiting
        • Karadeniz Technical University Faculty of Medicine
  • United Kingdom
      • London, United Kingdom, NW1 2BU
        • Recruiting
        • University College London Hospitals
      • London, United Kingdom, E1 2ES
        • Recruiting
        • Barts Health NHS Trust
      • London, United Kingdom, E1 1BB
        • Recruiting
        • Barts Health NHS Trust
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Recruiting
        • Plymouth Hospitals NHS Trust
    • Kent
      • Canterbury, Kent, United Kingdom, CT1 3NG
        • Recruiting
        • Kent and Canterbury Hospital
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE5 4PW
        • Recruiting
        • Leicester Royal Infirmary
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Regents of the University of California Los Angeles
      • San Diego, California, United States, 92037
        • Recruiting
        • University of California San Diego Moores Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Mercy Health Lacks Cancer Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Mayo Clinic
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Not yet recruiting
        • East Carolina University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • Recruiting
        • Integris Southwest Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Safety and Dose Confirmation Run-in Period (SRP): Obexelimab
Obexelimab will be administered as an SC injection for 24 weeks.
Drug: Obexelimab
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcγRIIb, resulting in down regulation of B cell activity.
Experimental: Randomized Control Period (RCP): Obexelimab
Obexelimab will be administered as an SC injection for 24 weeks.
Drug: Obexelimab
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcγRIIb, resulting in down regulation of B cell activity.
Placebo Comparator: Randomized Control Period (RCP): Placebo
Placebo will be administered as an SC injection for 24 weeks
Other: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Dose Confirmation Run-in Period (SRP)
Time Frame: 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.
24 weeks
Randomized Control Period (RCP)
Time Frame: 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.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zenas BioPharma (USA), LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2023

Primary Completion (Estimated)

March 14, 2026

Study Completion (Estimated)

June 8, 2026

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZB012-03-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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