A Phase 2 interventional study of KZR-616 in Polymyositis and Dermatomyositis, sponsored by Kezar Life Sciences, Inc.. Completed at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Kezar Life Sciences, Inc. · Phase 2, Interventional, and Treatment
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.
This was 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 (NCT04033926), up to and including the Week 32 Visit, prior to the first dose of open-label KZR-616.
Patients were 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 received a subcutaneous (SC) injection of 30 mg KZR-616 at Visit 1 (Day 1), followed by weekly SC injections of 45 mg KZR-616 up to a maximum of 96 weeks. Study drug administration ended for all patients in Study KZR-616-003E when the last patient enrolled completed 48 weeks of dosing. Patients had a final follow-up visit 12 weeks after their last dose of KZR-616 (End of Study [EOS] Visit), for a maximum potential length of participation of 108 weeks.
184 studies on the registry are indexed under Dermatomyositis; 63 are open to participants now.
This study's enrollment of 18 is below the median of 35 across 130 interventional studies indexed under Dermatomyositis.
Browse Dermatomyositis studies →Kezar Life Sciences, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Compared within Dermatomyositis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Polymyositis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients received a SC injection of 30 mg KZR-616 at Visit 1 (Day 1), followed by weekly SC injections of 45 mg KZR-616 up to a maximum of 96 weeks. Study drug administration ended for all patients in Study KZR-616-003E when the last patient enrolled completed 48 weeks of dosing.
Drug: KZR-616
Subcutaneous 30 mg for 1 week, then 45 mg weekly
Also known as: KZR-616 Lyophile, zetomipzomib
Mean Total Improvement Score (TIS) at OLE Week 48
The mean Total Improvement Score (TIS) at OLE Week 48, which ranges from 0 to 100 \[low of 0 to high of 100, where higher scores are better\]. The timeframe of 48 weeks was selected because it represented the maximum timeframe of dosing for the last patient enrolled as the study drug administration ended when the last patient enrolled completed 48 weeks of dosing.
Time frame: 48 weeks
| Milestone | KZR-616 45 mg + Standard Therapy (Open-label) |
|---|---|
| Started | 18 |
| Completed | 8 |
| Not completed | 10 |
The mean Total Improvement Score (TIS) at OLE Week 48, which ranges from 0 to 100 \[low of 0 to high of 100, where higher scores are better\]. The timeframe of 48 weeks was selected because it represented the maximum timeframe of dosing for the last patient enrolled as the study drug administration ended when the last patient enrolled completed 48 weeks of dosing.
| score on a scale | KZR-616 45 mg + Standard Therapy (Open-label) |
|---|---|
| Mean Total Improvement Score (TIS) at OLE Week 48 | 36.4 ± 23.2 |
Collected over Up to 108 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| KZR-616 45 mg + Standard Therapy (Open-label) | 0/18 (0%) | 1/18 (5.6%) | 17/18 (94.4%) |
| Event | KZR-616 45 mg + Standard Therapy (Open-label) |
|---|---|
| Wellens' syndromeCardiac disorders | 1/18 |
| Cholecystitis acuteHepatobiliary disorders | 1/18 |
| Event | KZR-616 45 mg + Standard Therapy (Open-label) |
|---|---|
| Injection site reactionGeneral disorders | 8/18 |
| NauseaGastrointestinal disorders | 6/18 |
| DiarrhoeaGastrointestinal disorders | 5/18 |
| PainGeneral disorders | 5/18 |
| PyrexiaGeneral disorders | 5/18 |
| HeadacheNervous system disorders | 5/18 |
| VomitingGastrointestinal disorders | 4/18 |
| ChillsGeneral disorders | 4/18 |
| Injection site erythemaGeneral disorders | 4/18 |
| FatigueGeneral disorders | 3/18 |
| Age, Continuous(years) | KZR-616 45 mg + Standard Therapy (Open-label) |
|---|---|
| Mean | 52.7 ± 14.3 |
| Sex: Female, Male(Participants) | KZR-616 45 mg + Standard Therapy (Open-label) |
|---|---|
| Female | 13 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | KZR-616 45 mg + Standard Therapy (Open-label) |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 13 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | KZR-616 45 mg + Standard Therapy (Open-label) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 12 |
| More than one race | 0 |
| Unknown or Not Reported | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2020 to primary completion in Mar 2023, 28 months.
Results were first posted in Jun 2024, 1 year 2 months after primary completion.
Of 19 phase 2 interventional studies under Dermatomyositis, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 52. This study's 28 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: KZR-616
Kezar Life Sciences, Inc.