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Experimental drug shows promise for rare muscle diseases

NCT ID NCT04628936

Disease control Sponsor: Kezar Life Sciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the long-term safety and effectiveness of a drug called KZR-616 in 18 adults with active polymyositis or dermatomyositis, rare diseases that cause muscle inflammation and weakness. Participants who completed an earlier study received weekly injections of KZR-616 for up to 48 weeks. The main goal was to see if the drug improved muscle function and disease activity over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KZR-616 (zetomipzomib), a drug given as a weekly injection under the skin
What this could lead to
If successful, this could point toward a new treatment option for people with polymyositis or dermatomyositis, helping to control disease activity.
What could go wrong
This is a small, early-phase study with only 18 participants and no placebo comparison, so results may not apply broadly. The drug may cause side effects and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

18 people

The number who actually took part.

Started

Nov 2020

Finished

Jun 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

dermatomyositis muscle tissue disorder musculoskeletal system disorder myositis disease polymyositis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dermatomyositis Polymyositis

Contacts and locations

Locations

  • KZR Research Site

    Beverly Hills, California, 90211, United States

  • KZR Research Site

    Orange, California, 92868, United States

  • KZR Research Site

    Miami, Florida, 33136, United States

  • KZR Research Site

    Kansas City, Kansas, 66160, United States

  • KZR Research Site

    Baltimore, Maryland, 21224, United States

  • KZR Research Site

    Ann Arbor, Michigan, 48109, United States

  • KZR Research Site

    Duncansville, Pennsylvania, 16635, United States

  • KZR Research Site

    Pittsburgh, Pennsylvania, 15213, United States

  • KZR Research Site

    Austin, Texas, 78756, United States

  • KZR Research Site

    Prague, Czechia

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