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New drug cizutamig tested for rare hardening skin disease

NCT ID NCT07158996

Disease control Sponsor: Ruijin Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This early-phase trial will test the safety and tolerability of a new drug called cizutamig in 10 adults with systemic sclerosis, a rare autoimmune disease that causes skin and organ hardening. Participants must have moderate to severe skin involvement and have not responded well to standard therapies. The study aims to see if cizutamig is safe enough to study further.

What this could mean

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

Active substance
cizutamig
What this could lead to
If it works, this could point toward a new treatment option for systemic sclerosis, a rare autoimmune disease that hardens the skin and organs.
What could go wrong
This is a very early, small trial with only 10 participants, so results may not apply to everyone. The main goal is safety, not proof of effectiveness, and side effects are unknown.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 10 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 75 years

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.

ICriteria: Inclusion Criteria: 1. 18 to 75 years old at the time of signing the informed consent form (ICF) 2. Diagnosis of SSc according to the 2013 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) classification criteria 3. Diffuse cutaneous SSc according to the LeRoy criteria 4. Positive for at least 1 SSc-specific parameter as specified in the protocol 5. Disease duration of ≤ 7 years 6. mRSS ≥ 15 7. Inadequate response to therapies defined in the protocol. Exclusion Criteria: 1. Inadequate clinical laboratory parameters at Screening 2. Receipt of or inability to discontinue any excluded therapies as specified in the protocol 3. Receipt of live vaccine within 4 weeks prior to Screening 4. Presence of any concomitant autoimmune disease other than the disease being studied 5. Receiving or anticipated to require total parenteral nutrition during the study 6. Active or history of intestinal pseudo-obstruction OR small intestinal bacteria overgrowth 7. Active or history of gastric antral vascular ectasia 8. Active digital ischemia with gangrene OR requiring antibiotics or amputation at Screening or during the study 9. Active or history of scleroderma renal crisis 10. History of progressive multifocal leukoencephalopathy 11. History of primary immunodeficiency or a hereditary deficiency of the complement system 12. Central nervous system (CNS) disease 13. Have presence of 1 or more significant concurrent medical conditions per investigator judgment 14. Have a diagnosis or history of malignant disease within 5 years prior to Screening 15. Inability to comply with contraception requirements as specified in the protocol

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Conditions

The condition(s) this trial relates to.

systemic sclerosis

As listed by the trial registrant

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

Systemic sclerosis (SSC)

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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