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Monoclonal Antibodies
Obexelimab for Autoimmune Hemolytic Anemia
Phase 3
Recruiting
Research Sponsored by Zenas BioPharma (USA), LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study Summary
This trial will investigate a new drug to treat Warm Autoimmune Hemolytic Anemia, a blood disorder.
Who is the study for?
Adults diagnosed with Warm Autoimmune Hemolytic Anemia (wAIHA) who have tried at least one treatment without success can join. They must show symptoms of anemia and have had wAIHA for over three months. People can't join if they've had recent blood transfusions, used certain immune therapies in the past six months, or are on more than two wAIHA medications.Check my eligibility
What is being tested?
The trial is testing Obexelimab's effectiveness and safety against a placebo in treating wAIHA. Participants will be randomly assigned to receive either Obexelimab or a placebo to compare outcomes between the two groups.See study design
What are the potential side effects?
Potential side effects of Obexelimab may include reactions at the injection site, increased risk of infections, headaches, nausea, and possible immune system-related issues. The exact side effects will be monitored throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Randomized Control Period (RCP)
Safety and Dose Confirmation Run-in Period (SRP)
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Safety and Dose Confirmation Run-in Period (SRP): ObexelimabExperimental Treatment1 Intervention
Obexelimab will be administered as an SC injection for 24 weeks.
Group II: Randomized Control Period (RCP): ObexelimabExperimental Treatment1 Intervention
Obexelimab will be administered as an SC injection for 24 weeks.
Group III: Randomized Control Period (RCP): PlaceboPlacebo Group1 Intervention
Placebo will be administered as an SC injection for 24 weeks
Find a Location
Who is running the clinical trial?
Zenas BioPharma (USA), LLCLead Sponsor
5 Previous Clinical Trials
353 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking more than 2 medications for warm autoimmune hemolytic anemia.I have tried at least one treatment for wAIHA that didn't work.I am 18 years old or older.I have been treated for warm autoimmune hemolytic anemia for over 3 months.I haven't used any B cell-targeting treatments in the last 6 months.I have not received IV Ig or epoetin alfa in the last 6 weeks.I have been diagnosed with wAIHA confirmed by a specific blood test.I have a type of anemia not caused by autoimmune disorders or lymphoid cancers.I have a type of anemia caused by cold-reacting antibodies.I have received a blood transfusion in the last 2 weeks.I have symptoms of anemia.I have a genetic or acquired condition causing my anemia.
Research Study Groups:
This trial has the following groups:- Group 1: Safety and Dose Confirmation Run-in Period (SRP): Obexelimab
- Group 2: Randomized Control Period (RCP): Obexelimab
- Group 3: Randomized Control Period (RCP): Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Federal Drug Administration sanctioned the Safety and Dose Confirmation Run-in Period (SRP): Obexelimab?
"The safety and efficacy of obexelimab has been fairly well established, as evidenced by this Phase 3 trial. A score of 3 was given in recognition of the scientific data that supports its use."
Answered by AI
What is the aggregate amount of people participating in this experiment?
"Affirmative. Visible on clinicaltrials.gov, the trial is still searching for participants and was first announced on June 23rd 2023 prior to its most recent update of August 15th 2023. The study requires 134 individuals from a single enrolment centre."
Answered by AI
Is this investigation actively recruiting participants?
"Affirmative, clinicaltrials.gov verifies that the trial is actively recruiting participants after its June 23rd, 2023 commencement date and most recent update on August 15th of this year. 134 volunteers are needed for the project at one particular site."
Answered by AI
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