Jump to Header Jump to Main Content Jump to Footer

KZR-616

Namita Goyal


A Study On:

  • Neurological/ Psychological
  • Neurology

Status:

  • Open

Eligibility

Polymyositis
Dermatomyositis
18 Years and older (Adult, Older Adult)

Interested in joining this trial?

Official Title

An Open-label Extension to the Phase 2 Randomized, Double-blind, Placebo-controlled, Crossover Multicenter Study to Evaluate the Safety and Efficacy of KZR-616 in the Treatment of Patients With Active Polymyositis or Dermatomyositis

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.


Eligibility

You can join if...

Inclusion Criteria:

  1. Must have successfully completed Study KZR-616-003 through Week 32, including the Week 32 Visit assessments
  2. 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.
  3. 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:

  1. 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.
  2. 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.
  3. 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.
  4. Have hypersensitivity to KZR-616 or any of its excipients.

Get in touch with our study team