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New drug aims to soften skin and protect lungs in rare disease

NCT ID NCT07047690

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a drug called nemolizumab in 162 adults with systemic sclerosis, a disease that causes skin thickening and can harm internal organs. Participants receive either nemolizumab or a placebo as a shot under the skin for 52 weeks. The main goal is to see if the drug reduces skin hardness and to find the best dose.

What this could mean

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

Active substance
Nemolizumab (a drug given as a shot under the skin)
What this could lead to
If it works, this could point toward a new treatment to control skin hardening and possibly slow lung damage in systemic sclerosis.
What could go wrong
This is an early Phase 2 trial with only 162 people, so results may not apply to everyone. The drug may not work better than placebo, and side effects 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 2

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

Participants

About 162 people

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

Started

Feb 2026

Expected to finish

Jul 2028

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: 1. Participant must be 18 years of age or older, at the time of signing the Informed Consent Form. 2. Classification of systemic sclerosis (SSc) as defined by the 2013 American College of Rheumatology \[ACR\]/European League Against Rheumatism \[EULAR\] criteria. 3. Modified Rodnan Skin Score. 1. Diffuse cutaneous systemic sclerosis (DcSSc) participants and modified Rodnan Skin Score (mRSS) of greater than equal to (\>=)12 and less than (\<)30 at both screening and baseline 2. Limited cutaneous systemic sclerosis (LcSSc) participants with mRSS \>=8 at both screening and baseline. LcSSc participants with positive anti-centromere at screening are excluded. 4. Disease duration in DcSSc participants \<= 5 years from screening and LcSSc participants \<=2 years from screening is defined as the time from the first non-Raynaud's phenomenon manifestation of SSc. 5. Participants are permitted to receive the following background therapies stable for at least 3 months prior to baseline, including any combination of the following: 1. Nintedanib (\<150mg twice daily) and/or 2. One of the following: 1. Methotrexate (MTX) (\<25mg weekly) or 2. Mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or mycophenolic acid (MPA) (\<3000mg daily MMF, \<2160mg daily for MPS or MPA) NOTE: MTX should not be used in combination with MMF/MPS/MPA 6. Participants with evidence for active or progressive disease. 7. Men (whose female partner can become pregnant) and women of childbearing potential will be required to use effective means of contraception or commit to true abstinence, when this is in line with preferred and usual lifestyle of the participant, during the study and for at least 12 weeks after receiving the last study treatment. 8. Female participants of non-childbearing potential 9. Signed informed consent Exclusion Criteria: 1. Anti-centromere antibody positive at screening for participants with LcSSc. 2. Anti-RNA polymerase 3 antibody positive for participants with a disease duration \>18months. 3. Creatinine clearance \<30 milli liter per minute \[ml/min\] (calculated by Cockcroft-Gault formula). 4. Positive serology results (hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HbcAb\], hepatitis C \[HCV\] antibody with positive confirmatory test for hepatitis C virus \[HCV\] antibody with positive HCV RNA, or human immunodeficiency virus \[HIV\] antibody). 5. FVC \<50% of predicted normal value, and DLCO \<40% of predicted normal value (corrected for Hb) at screening and baseline. 6. Known diagnosis of clinically significant respiratory disorders other than ILD, including severe chronic obstructive pulmonary disease, severe asthma, recent (within 3 months) severe respiratory infections or history of recurrent respiratory infections, smoking, and any other respiratory condition that, in the opinion of the investigator, could interfere with the study or pose a risk to the participant. 7. Currently listed and/or anticipated to be listed for lung transplantation within the next 12 months. 8. Cardiovascular disease with clinically significant arrhythmia requiring therapy, congestive heart failure (New York Heart Association Class III-IV functional capacity), unstable angina, uncontrolled hypertension, Cor pulmonale, or symptomatic pericardial effusion. 9. History of myocardial infarction in the last 6 months prior to screening. 10. Pulmonary hypertension WHO Functional Class III or higher (as defined by WHO 2009) requiring treatment. 11. Clinical signs of severe malabsorption in the opinion of the investigator or needing parenteral nutrition. 12. History of scleroderma renal crisis (SRC) 6 months prior to screening. 13. Participants with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment). 14. Body weight of \<30.0 kilogram (Kg) at screening or BL 15. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed, or unwilling to use appropriate contraception measures during the study period 16. Previous treatment with nemolizumab 17. Participants with the primary diagnosis of a rheumatic autoimmune disease other than SSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis, systemic vasculitis, Sjogren's syndrome, anti-synthetase syndrome, or mixed CTD, as determined by the investigator with consultation of the medical monitors 18. Systemic sclerosis-like illness including but not limited to localized scleroderma (morphea), eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibro mucinous conditions (scleredema, scleromyxedema), scleroderma-like conditions that are associated with environmental chemical and drug exposure (e.g., toxic rapeseed oil, vinyl chloride, bleomycin, gadolinium-based contrast agents \[nephrogenic systemic fibrosis\], or due to metabolic disease) 19. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, e.g., monoclonal antibody) or to any of the study treatment excipient 20. Known active bacterial, viral, fungal, or any major episode of infection requiring hospitalization or treatment with IV antibiotics or antivirals within 4 weeks prior to screening, or oral antibiotics within 2 weeks prior to screening. Participants may be rescreened once the infection has resolved. 21. History of a primary immunodeficiency 22. History of Bone Morrow Transplantation. Chimeric Antigen Receptor (CAR)-T Cell Therapy or any other genetically engineering cells 23. History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for (1) basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have been treated and have no evidence of recurrence in the last 12 weeks before the BL visit, or (2) actinic keratoses that have been treated 24. History of alcohol or substance abuse dependence or any condition that, in the investigator's opinion makes the participant unreliable to following instructions and complete the study 25. In the opinion of the investigator, the participant has any medical condition, including clinically significant pulmonary abnormalities, or psychological condition,or clinically significant laboratory abnormalities that could pose undue risk to the participant, prevent study completion or adversely affect the validity or interpretability of the study measurements or interfere with the study assessments, or impede the participant's ability to complete the study. 26. Participant has not adhered to the restrictions in select treatments prior to screening or is not expected to be compliant with restrictions during the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Galderma Investigational Site # 6213

    RECRUITING

    Sankt Gallen, 9007, Switzerland

  • Galderma Investigational Site # 8743

    RECRUITING

    Ann Arbor, Michigan, 48109-5000, United States

  • Galderma Investigational Site#7096

    RECRUITING

    Arlington, Texas, 76012, United States

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