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New antibody drug aims to halt Scleroderma's grip

NCT ID NCT05726630

Disease control Sponsor: Biocad 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether the drug divozilimab can reduce skin thickening and protect lung function in people with systemic scleroderma, a rare autoimmune disease. About 152 adults and teens with active disease will receive either the drug or a placebo. The study is double-blind, meaning neither patients nor doctors know who gets what.

What this could mean

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

Active substance
Divozilimab (a lab-made antibody that targets certain immune cells)
What this could lead to
If it works, this could offer a new treatment option to slow skin hardening and preserve lung function in people with systemic scleroderma.
What could go wrong
This is a Phase 3 trial, but results are not yet known. The drug may not improve symptoms better than placebo, and side effects from immune suppression 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

152 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Feb 2027

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

16 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: * For subjects aged ≥16 years: a diagnosis of systemic scleroderma according to the ACR/EULAR 2013 criteria; a modified Rodnan skin score (mRSS) ≥10 and ≤20 * For subjects aged ≥14 and \<16 years: a diagnosis of systemic scleroderma according to the PRES/ACR/EULAR 2007 criteria. * FVC ≥ 40 % of the due value. Exclusion Criteria: * Induced scleroderma. * Silicone implants/protheses. * Digital ulcers with signs of infection or indications for any amputation. * Blood biochemistry or hematological abnormalities at screening. * FEV1/FVC \< 0.7 and FEV1\< 50 % at screening. * History of threatment with anti-CD20 monoclonal antibodies.

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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 scleroderma

Contacts and locations

Locations

  • Chelyabinsk Regional Clinical hospital

    Chelyabinsk, Russia

  • Clinical Rheumatology Hospital №25

    Saint Petersburg, Russia

  • North-Western state Medical University named after I.I. Mechnikov

    Saint Petersburg, Russia

More trials for these conditions

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