Phase 3 Clinical Trial
What is the SNP-ACTH (1-39) Gel Study?
This is a Phase 3 clinical trial comparing SNP-ACTH (1-39) Gel to rituximab in the treatment of PMN. The trial will be divided into two parts: Phase 3a and Phase 3b.
Cerium is currently enrolling patients in its Phase 3 clinical trial at various sites across the United States, Canada, and India.
Phase 3a
Phase 3a is the dose finding part of the study which will enroll a total of 16 patients randomized to two different doses levels:
- 8 patients at 3mg SNP_ACTH (1-39) Gel subcutaneous injection (sc) 3 times per week; or
- 8 patients on 5mg SNP-ACTH (1-39) Gel sc injection 3 times per week
Data from the Phase 3a part of the study will be assessed at regular intervals and will inform the dose selection for the Phase 3b. The optimal dose will be determined based on a risk/benefit assessment from data obtained from the Phase 3a part of the study, with the earliest assessment being conducted after all patients have completed at least 2 months of therapy.
Phase 3b
Phase 3b is an open label superiority trial. This phase will enroll 132 patients randomized 1:1 to either 12 months of 1g Rituximab therapy (2 treatment cycles at month 1 and month 6) or 12 months of SNP-ACTH (1-39) Gel treatment at the dose level determined in the Phase 3a.
What to Expect
Phase 3a
Eligible participants for the Phase 3a will meet with a healthcare professional, either at a study center or a location of the patient’s choosing, about 21 times over the course of 1 year. There will also be times when participants speak to a member of the study team by telephone or video conference to discuss treatment compliance and side effects.
Phase 3b
Eligible participants, randomized to SNP-ACTH (1-39) Gel for the Phase 3b, will meet with a healthcare professional, either at a study center or a location of the patient’s choosing, about 18 times over the course of 1 year. Eligible participants, randomized to rituximab in the Phase 3b, will visit a study center about 12 times over the course of 1 year.
Tests and Assessments
In both arms several tests and assessments will be performed to monitor the participant’s health:
Physical Exam
Blood and urine collection and testing
Anti-PLA2R antibody testing
eGFR MEASUREMENT
Who Can Enroll?
Participants must meet the study criteria to enroll in the clinical study. To see the full list of inclusion and exclusion criteria please visit clinicaltrials.gov.
Want to Learn More?
Please email medical@cerium.com if you have questions or would like to learn more about this clinical trial.
