Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.

Study Purpose

This is an open-label study to evaluate the long-term efficacy and safety of KZR-616 in patients with active PM or 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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:

  • - Have clinical evidence of significant unstable or uncontrolled diseases other than the disease under study, that in the opinion of the Investigator or Sponsor/designee, could confound the results of the study, put the patient at undue risk, or interfere with protocol adherence.
  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04628936
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Kezar Life Sciences, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kezar Study Director
Principal Investigator Affiliation Kezar Life Sciences, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Polymyositis, Dermatomyositis
Study Website: View Trial Website
Additional Details

This is an open-label study to evaluate the long-term efficacy and safety of KZR-616 in patients with active polymyositis or dermatomyositis 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. Patients will be evaluated for eligibility according to the entry criteria at, or within 8 weeks after, the Week 32 Visit (ie, the End of Treatment [EOT] Visit [Visit 34]) of Study KZR-616-003. All patients will receive a SC injection of 30 mg KZR-616 at Visit 1 (Day 1), followed by weekly SC injections of 45 mg KZR-616 through Week 48 (EOT Visit). The final follow-up visit will occur 12 weeks following the last dose of KZR-616 (End of Study [EOS] Visit), for a total length of participation of up to approximately 60 weeks.

Arms & Interventions

Arms

Experimental: KZR-616 45 mg + standard therapy (open-label)

All patients will receive a subcutaneous (SC) injection of 30 mg KZR-616 at Visit 1 (Day 1), followed by weekly SC injections of 45 mg KZR-616 through Week 48 (EOT Visit).

Interventions

Drug: - KZR-616

KZR-616 subcutaneous injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

KZR Research Site, Irvine, California

Status

Address

KZR Research Site

Irvine, California, 92698

KZR Research Site, Kansas City, Kansas

Status

Address

KZR Research Site

Kansas City, Kansas, 66160

KZR Research Site, Ann Arbor, Michigan

Status

Address

KZR Research Site

Ann Arbor, Michigan, 48109

KZR Research Site, Duncansville, Pennsylvania

Status

Address

KZR Research Site

Duncansville, Pennsylvania, 16635

KZR Research Site, Austin, Texas

Status

Address

KZR Research Site

Austin, Texas, 78756