Phase 3 N=71 Randomized Quadruple-blind Treatment

Phase 3 Study of SNF472 for Calciphylaxis

Calciphylaxis · Calcific Uremic Arteriolopathy

Bottom Line

View on ClinicalTrials.gov: NCT04195906 ↗

Enrolled (actual)

Serious AEs

36.6%

Results posted

Feb 2024

Primary outcome: Primary: Absolute Change in the BWAT - CUA Score for the Primary Lesion — -5.3; -6.0 score on a scale — p=0.877

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Experimental: SNF472 (Drug); Placebo Comparator: Placebo (Drug); Experimatenl SNF472 (Open-label) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sanifit Therapeutics S. A.
Primary completion: Oct 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Absolute Change in the BWAT - CUA Score for the Primary Lesion	-5.3; -6.0	0.877
PRIMARY Absolute Change in Pain Visual Analog Score	-19.5; -32.2	0.146
SECONDARY Absolute Change in the Wound-Quality of Life Score	-0.67; -0.74	0.706
SECONDARY Absolute Change in the BWAT Total Score for the Primary Lesion	-11.0; -11.7	0.995
SECONDARY Qualitative Wound Image Evaluation for the Primary Lesion	6; 7; 0; 1; 23; 18	0.384
SECONDARY Rate of Change in Opioid Use as Measured in Morphine Milligram Equivalents (MME)	0.46; -0.11	0.406

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).

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04195906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.