Phase 2
N=18
Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.
Polymyositis · Dermatomyositis
Bottom Line
View on ClinicalTrials.gov: NCT04628936 ↗Enrolled (actual)
18
Serious AEs
5.6%
Results posted
Jun 2024
Primary outcome: Primary: Mean Total Improvement Score (TIS) at OLE Week 48 — 36.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- KZR-616 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kezar Life Sciences, Inc.
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Total Improvement Score (TIS) at OLE Week 48 |
36.4 | — |
Summary
This was an open-label study to evaluate the long-term efficacy and safety of KZR-616 in patients with active polymyositis (PM) or dermatomyositis (DM) who completed the double-blind treatment period of Study KZR-616-003, up to and including the Week 32 Visit, prior to the first dose of open-label KZR-616.
Eligibility Criteria
Inclusion Criteria
- Must have successfully completed Study KZR-616-003 through Week 32, including the Week 32 Visit assessments
- Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test prior to the first dose of KZR-616 in KZR-616-003E, and must agree to continue to use a highly effective method of birth control until completion of the study.
- Male patients must continue to use an effective contraception method for 1 week following their last dose of KZR-616 or be congenitally or surgically sterile.
Exclusion Criteria
- Has participated in any clinical study other than KZR-616-003 between the Week 32 Visit of Study KZR-616-003 and the first study visit of KZR-616-003E, if they are not on the same calendar day.
- Are females who are breastfeeding or who plan to become pregnant during the study, or who are actively trying to conceive at the time of signing of the informed consent form.
- Have hypersensitivity to KZR-616 or any of its excipients.
Data sourced from ClinicalTrials.gov (NCT04628936). 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.