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New drug shows promise for rare muscle diseases

NCT ID NCT06698796

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Updated 2 times

Summary

This study tests the long-term safety and effectiveness of dazukibart in people with dermatomyositis or polymyositis, rare diseases that cause muscle weakness and rashes. Participants who completed a previous study can join. Some will receive the drug via IV every 4 weeks for about a year, while others will only have safety check-ups. The goal is to see if dazukibart can help control symptoms 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
dazukibart (a drug given as an IV infusion every 4 weeks)
What this could lead to
If successful, this could provide a long-term treatment option to control muscle inflammation and improve daily function for people with dermatomyositis or polymyositis.
What could go wrong
This is an extension study, so it builds on earlier results. However, it is still testing safety and efficacy, and not all participants will receive the drug. Side effects or lack of benefit are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 211 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jul 2031

An estimate. End dates often move.

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: * Participants that completed a qualifying study through Week 52. Exclusion Criteria: * Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation. * Previous administration with an investigational product (drug or vaccine) other than dazukibart in a qualifying study within 30 days (or as determined by the local requirement) or 5 half-lives preceding baseline in this study (whichever is longer). * Current use of any prohibited concomitant medication(s). * Active bacterial, viral, fungal, mycobacterial or other infections. * Ongoing adverse event in a qualifying study or the participant has met safety monitoring criteria in a qualifying study that have not resolved. * Investigator site staff or sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

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Conditions

The condition(s) this trial relates to.

acquired idiopathic inflammatory myopathy dermatomyositis polymyositis

As listed by the trial registrant

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

Dermatomyositis Polymyositis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

    RECRUITING

    Glendale, Arizona, 85306, United States

  • Anhui Provincial Hospital

    RECRUITING

    Hefei, Anhui, 230071, China

  • Arthritis & Rheumatology Research Institute, PLLC

    NOT_YET_RECRUITING

    Frisco, Texas, 75035, United States

  • CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)

    RECRUITING

    Ernākulam, Kerala, 682040, India

  • Centro de Investigaciones Médicas Tucuman

    RECRUITING

    SAN M. de Tucuman, Tucumán Province, T4000AXL, Argentina

  • Chi Mei Medical Center

    RECRUITING

    Tainan, 71004, Taiwan

  • Cryptex Investigación Clínica S.A. de C.V.

    RECRUITING

    Cuauhtémoc, Mexico City, 06100, Mexico

  • Debreceni Egyetem Klinikai Kozpont

    RECRUITING

    Debrecen, 4032, Hungary

  • First Affiliated Hospital of Kunming Medical University

    RECRUITING

    Kunming, Yunnan, 650032, China

  • Hacettepe Universite Hastaneleri

    RECRUITING

    Altindağ, Ankara, 06230, Turkey (Türkiye)

  • IR Medical Center SA - Instituto de Reumatologia

    RECRUITING

    Mendoza, Mendoza Province, T5500, Argentina

  • Institute of Science Tokyo Hospital

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8519, Japan

  • Medanta - The Medicity

    RECRUITING

    Gurugram, Haryana, 122001, India

  • Medical Center Artmed

    RECRUITING

    Plovdiv, 4000, Bulgaria

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-637, Poland

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10002, Taiwan

  • Nerve & Muscle Center of Texas

    RECRUITING

    Houston, Texas, 77030, United States

  • Nippon Medical School Hospital

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8603, Japan

  • Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty

    RECRUITING

    Bialystok, Podlaskie Voivodeship, 15-707, Poland

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, 100730, China

  • Renji Hospital Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200001, China

  • Renji Hospital Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200127, China

  • Rheumatology & Pulmonary Clinic

    ACTIVE_NOT_RECRUITING

    Beckley, West Virginia, 25801, United States

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, Central District, 5262100, Israel

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330036, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.