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A Phase 3 Study of Obexelimab in Patients with Warm Autoimmune Hemolytic Anemia
EU CTIS ID: 2022-501005-12-00
What this study is testing
Part A: Safety and Dose Confirmation Run-in Period (SRP) - To evaluate the safety and tolerability of weekly subcutaneous (SC) administration of obexelimab in patients with wAIHA - To evaluate the clinical benefit of weekly SC administration of obexelimab on anemia in patients with wAIHA Part B: Randomized Control Period (RCP) - To evaluate the clinical benefit of weekly SC administration of obexelimab on anemia in patients with wAIHA Part C: Open-Label Extension (OLE) Period - To evaluate the safety and tolerability of weekly SC administration of obexelimab in patients with wAIHA - To evaluate Hgb response and total duration of response of weekly SC administration of obexelimab in patients with wAIHA - To evaluate the clinical benefit of weekly SC administration of obexelimab on rescue therapy use in patients with wAIHA
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- PARTS A AND B: INCLUSION CRITERIA 1. Males and females ≥ 18 years of age at the time of signing the informed consent
- 10. Screening neutrophil count ≥ 1,000 mm3
- 11. Screening serum albumin and serum calcium concentrations within the normal range
- 12. Screening total serum IgG of ≥ 400 mg/dL
- 13. Screening creatine kinase value < 2 × ULN
- 14. Patients with a history of splenectomy must be at least 4 months post resection prior to enrollment (SRP) or randomization (RCP) and must be vaccinated as per country-specific immunization schedules
You likely can't join if
- PARTS A AND B: EXCLUSION CRITERIA 1. Have cold antibody AIHA, cold agglutinin syndrome, mixed type (i.e., warm and cold) AIHA, or paroxysmal cold hemoglobinuria
- 10. Evidence of active tuberculosis (TB) or at high risk for TB based on at least one of the following: a. History of active TB or latent TB, unless completion of treatment according to local guidelines is documented b. Positive, indeterminate, or invalid interferon-gamma (IFNγ) release assay results at screening, unless treatment is documented. Patients with an indeterminate test result can repeat the test once either centrally or locally, but if the repeat test is also indeterminate, the patient is excluded c. Signs of symptoms that could represent active TB d. Chest radiograph, computed tomography scan, or magnetic resonance imaging that suggests possible diagnosis of TB
- 11. History or evidence of a clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, oncologic, renal, hepatic, metabolic, hematologic, psychiatric, active infection), that, in the opinion of the investigator, would pose a risk to patient safety or interfere with the study evaluations, procedures, or completion
- 12. Known allergy to mAb therapy
- 13. Known hypersensitivity to dextran or components of dextran
- 14. Active infection (e.g., pneumonia, biliary tract infection, diverticulitis, Clostridium difficile infection) that requires parenteral or oral anti-infectives and/or hospitalization, and/or is assessed as serious/clinically significant by the investigator, within 8 weeks prior to screening. Patients may be re-screened after the 8-week exclusionary period has passed
See the full eligibility criteria
Who can join
- PARTS A AND B: INCLUSION CRITERIA 1. Males and females ≥ 18 years of age at the time of signing the informed consent
- 10. Screening neutrophil count ≥ 1,000 mm3
- 11. Screening serum albumin and serum calcium concentrations within the normal range
- 12. Screening total serum IgG of ≥ 400 mg/dL
- 13. Screening creatine kinase value < 2 × ULN
- 14. Patients with a history of splenectomy must be at least 4 months post resection prior to enrollment (SRP) or randomization (RCP) and must be vaccinated as per country-specific immunization schedules
- 15. Patients with autoimmune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis) may be eligible if they are receiving stable treatment (no changes in disease- related concomitant medications), and the severity of disease has been stable for at least 4 months prior to enrollment (SRP) or randomization (RCP)
- 16. Removed in Amendment 2 v3.0
- 17. Females not pregnant (see Appendix 4), not breastfeeding, and for whom at least one of the following conditions applies: a. Not of childbearing potential, as defined in Appendix 4 OR b. FOCBP with a negative serum pregnancy test at screening and a negative urine pregnancy test prior to the first dose of study drug and agreement to follow the contraceptive guidance in Appendix 4 for the duration of the study and for at least 8 weeks after the last administration of study drug c. Agree to refrain from egg donation until at least 8 weeks after the last dose of study drug
- 18. Males for whom the following conditions apply: a. Agree to (i) abstain from intercourse or (ii) use contraception (as detailed in Appendix 4) for the duration of the study and for at least 8 weeks after the last dose of IMP, or (iii) be surgically sterile for the duration of the study AND b. Agree to refrain from donating sperm for the duration of the study and for at least 8 weeks after the last dose of IMP
- 19. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- 2. Diagnosed with wAIHA for at least 3 months and currently receiving treatment for wAIHA or have previously received treatment for wAIHA (treatment-naive patients are not eligible)
- PART C: OLE PERIOD INCLUSION CRITERIA 1. Completed the Week 24 SRP or RCP visit 2. Have not had IMP discontinued due to any of the following safety reasons: a. Pregnancy b. Malignancy c. Hypersensitivity to IMP d. Determination that the patient was ineligible for the SRP and RCP e. For any reason deemed necessary by the investigator for patient safety 3. Have not discontinued from IMP due to unblinding of a patient 4. FOCBP must have a negative serum pregnancy test prior to enrollment in the OLE Period 5. Have not received a transfusion within 2 weeks prior to first dose in the OLE Period 6. Not receiving more than 2 concomitant medications for the treatment of wAIHA, excluding vitamins or other supplements, at the time of enrollment in the OLE Period 7. Patients must receive first dose of obexelimab in the OLE Period within 14 days of the Week 24 SRP/RCP visit 8. Willing to comply with all study protocol procedures and complete all study visits
- 3. Diagnosis of primary or secondary wAIHA as documented by a positive DAT specific for anti-IgG or anti-IgA
- 4. Failed at least 1 prior wAIHA treatment regimen, including steroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, danazol, vincristine, erythropoiesis-stimulating agents, or splenectomy (folate, iron, or other supplements do not fulfill this criterion). Failure is defined as a drop in Hgb of ≥ 1 g/dL and an increase in LDH of ≥ 1.5 × upper limit of normal (ULN) after a minimum of 4 weeks of GC therapy, or 3 months of immunosuppression therapy, respectively.
- 5. For the SRP (Part A) only, if on prednisone/prednisolone, the dose may not exceed 30 mg/day and must have been stable for at least 4 weeks prior to enrollment. Patients must remain on the stable dose throughout the SRP, except for patients on doses of >20 mg to ≤ 30 mg/day who may taper to no less than 20 mg/day and remain on a stable dose thereafter once they have achieved the primary endpoint and have a Hgb response on 2 consecutive in-clinic visits. For the RCP (Part B), if on prednisone/prednisolone, the dose may not exceed 20 mg/day and must have been stable for at least 4 weeks prior to randomization and remain stable throughout the RCP
- 6. If receiving immunosuppressants, must have been on a stable dose for at least 12 weeks prior to enrollment (SRP) or randomization (RCP) and remain on a stable dose throughout the SRP or RCP. Allowed concomitant immunosuppressants are azathioprine, mycophenolate mofetil/mycophenolic acid, cyclosporine, and cyclophosphamide
- 7. Hgb ≥ 7 to < 10 g/dL
- 8. At least one sign or symptom of anemia as assessed by the investigator at screening
- 9. Screening platelet count ≥ 50,000 mm3
What rules you out
- PARTS A AND B: EXCLUSION CRITERIA 1. Have cold antibody AIHA, cold agglutinin syndrome, mixed type (i.e., warm and cold) AIHA, or paroxysmal cold hemoglobinuria
- 10. Evidence of active tuberculosis (TB) or at high risk for TB based on at least one of the following: a. History of active TB or latent TB, unless completion of treatment according to local guidelines is documented b. Positive, indeterminate, or invalid interferon-gamma (IFNγ) release assay results at screening, unless treatment is documented. Patients with an indeterminate test result can repeat the test once either centrally or locally, but if the repeat test is also indeterminate, the patient is excluded c. Signs of symptoms that could represent active TB d. Chest radiograph, computed tomography scan, or magnetic resonance imaging that suggests possible diagnosis of TB
- 11. History or evidence of a clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, oncologic, renal, hepatic, metabolic, hematologic, psychiatric, active infection), that, in the opinion of the investigator, would pose a risk to patient safety or interfere with the study evaluations, procedures, or completion
- 12. Known allergy to mAb therapy
- 13. Known hypersensitivity to dextran or components of dextran
- 14. Active infection (e.g., pneumonia, biliary tract infection, diverticulitis, Clostridium difficile infection) that requires parenteral or oral anti-infectives and/or hospitalization, and/or is assessed as serious/clinically significant by the investigator, within 8 weeks prior to screening. Patients may be re-screened after the 8-week exclusionary period has passed
- 15. Chronic infection (e.g., bronchiectasis, chronic osteomyelitis, chronic pyelonephritis) or requiring chronic treatment with anti-infectives (e.g., antibiotics, antivirals)
- 16. Confirmed or suspected clinical immunodeficiency syndrome not related to treatment of wAIHA, or has a family history of congenital or hereditary immunodeficiency, unless confirmed absent in the patient
- 17. Acute hepatitis B infection (hepatitis B surface antigen-positive), active hepatitis C virus (HCV), or HIV infection. Patients will be excluded from the study if they have a positive test for active hepatitis B through detection of (a) hepatitis B surface antigen or (b) hepatitis B core antibody. In Japan, patients will be excluded if there is detection of (a) hepatitis B surface antigen or (b) hepatitis B surface antibody or (c) hepatitis B core antibody. Patients with a history of HCV will be excluded in the study unless there is documentation of a negative HCV ribonucleic acid level in the serum at 12 weeks or longer after the completion of HCV therapy
- 18. Intend to become pregnant, breastfeed, or are planning egg or sperm donation during the study or within 8 weeks after the last dose of study drug
- 19. Current alcohol/substance abuse/dependence, a history of alcohol/substance abuse/dependence within the 12 months prior to enrollment (SRP) or randomization (RCP), or, in the investigator’s opinion, there is evidence of ongoing alcohol/substance abuse/dependence
- 2. Have any other associated cause of hereditary or acquired hemolytic anemia
- 20. Major surgery (surgery requiring hospitalization ≥ 3 days or with a high risk of re-bleeding) within 4 months prior to enrollment (SRP) or randomization (RCP) or have plans for or have been scheduled for any elective surgery or major dental procedure during the study
- 21. Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant
- 22. Malignancy within 5 years of enrollment (SRP) or randomization (RCP)
- 23. Commitment to an institution by virtue of an order issued either by the judicial or the administrative authorities
- 3. Removed in Amendment 2 v3.0
- 4. Received a transfusion within 2 weeks prior to enrollment (SRP) or randomization (RCP)
- 5. Use of B cell–depleting, B cell–targeted, or other biologic immunomodulatory agents within the 6 months prior to enrollment (SRP) or randomization (RCP). Patients who received B cell–targeted therapy within 6 to 12 months prior to randomization must have a B cell count at screening that is within the laboratory reference range, as measured by the central laboratory
- 6. Received IV Ig or epoetin alfa within 6 weeks prior to enrollment (SRP) or randomization (RCP). The patient may be re-screened after the exclusionary period of 6 weeks has passed
- 7. Receiving more than 2 concomitant medications for the treatment of wAIHA, excluding vitamins or other supplements, at the time of screening
- 8. Received an investigational treatment or direct medical intervention in another clinical study within 12 weeks or < 5 half-lives of the investigational treatment, whichever is shorter, prior to screening
- 9. Received live vaccine or live therapeutic infectious agent within the 6 weeks prior to enrollment (SRP) or randomization (RCP)
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.