Phase 3 Study of SNF472 for Calciphylaxis

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives are to assess the efficacy, safety, and tolerability of SNF472 compared to placebo when added to background care for the treatment of calciphylaxis (CUA).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanifit Therapeutics S. A.

Criteria

Inclusion Criteria:

• Female or male subjects, 18 years of age or older

• Receiving maintenance HD in a clinical setting for at least 2 weeks prior to screening

• Clinical diagnosis of CUA by the Investigator including ≥1 CUA lesion with ulceration of the epithelial surface

• CUA wound-related pain shown by a Pain VAS score ≥50 out of 100

• Primary lesion that can be clearly photographed for the purpose of protocol-specified wound healing assessments.

• Willing and able to understand and sign the informed consent form and willing to comply with all aspects of the protocol

Exclusion Criteria:

• History of treatment with bisphosphonates within 3 months of baseline

• Severely ill subjects without a reasonable expectation of survival for at least 6 months

• Subjects with a scheduled parathyroidectomy during the study period

• Expectation for kidney transplant within the next 6 months based on Investigator assessment or identification of a known living donor

• Pregnant or trying to become pregnant, currently breastfeeding, or of childbearing potential (including perimenopausal women who have had a menstrual period within one year) and not willing to comply with protocol required contraception criteria

• Significant noncompliance with dialysis

• History of active malignancy within the last year with the exception of localized basal cell or squamous cell carcinoma

• Clinically significant illness other than CUA within 30 days

• Participation in an investigational study and receipt of an investigational drug or investigational use of a licensed drug within 30 days prior to screening.

• History or presence of active alcoholism or drug abuse as determined by the Investigator within 6 months

• Mental impairment, current significant psychiatric disease, or other conditions or circumstances that would make the subject unlikely to complete the study or comply with the study procedures.

• Subjects whose CUA lesions exhibit significant improvement, in the opinion of the Investigator, between the first and second screening visit