A study to find out if Nemolizumab works in participants with systemic sclerosis and how safe it is

Descrizione riassuntiva dello studio

The study investigates a new medication called Nemolizumab, which is already approved in the USA for the treatment of two other diseases. The aim is to find out whether it can improve the well-being of individuals with SSc. The main goal of this study is to determine how Nemolizumab affects skin thickness in participants with SSc. To do this, the investigators will conduct a test to assess how thick and hardened the skin of the participants is. This test is called the modified Rodnan Skin Score (mRSS). Another goal of the study is to find out whether Nemolizumab improves the lung condition of the participants. The investigators will also check how safe Nemolizumab is by monitoring the participants for the number and severity of their side effects. Participants will also complete questionnaires regarding the impact of the treatment on their quality of life and SSc symptoms. To understand how well Nemolizumab works, the effects of Nemolizumab will be compared with a placebo (a substance that looks like the investigational drug but contains no active ingredient). It is expected that a total of 162 adults will participate in this study at approximately 100 study centers worldwide.

(BASEC)

Intervento studiato

This study will be conducted in a double-blind manner, meaning that neither the investigators, the study staff, nor the participants will know which investigational drug is being administered to the participants. A computer will randomly decide which investigational drug the participants will receive. Participants will be randomly assigned to 3 groups, receiving either Nemolizumab in 2 different doses or the placebo. This is called randomization. This means that the probability of being assigned to a group is the same for each participant – like drawing names from a hat. The investigational drug will be administered every 4 weeks, and the dose will be adjusted according to the body weight of the respective participants. The investigational drug will be administered (as a subcutaneous injection) under the skin.

The study consists of the following 3 sections:

1. Pre-screening phase (8 weeks): The investigators will check whether participation in the study is appropriate for the participants.

2. Treatment period (52 weeks): Participants will receive the investigational drug on Day 1 and then every 4 weeks until Week 48. The main assessment of the effect of Nemolizumab will take place in Week 52 (4 weeks after the last administration).

3. Safety follow-up phase (8 weeks): The investigators will conduct some assessments after the last dose of the investigational drug and will monitor participants for side effects until Week 60 (12 weeks after the last administration).

Each participant will take part in the study for about 68 weeks. During the study, participants are expected to visit the clinic up to 16 times. The skin thickness of the participants will be checked, and they will be asked questions about their symptoms and their impact on their quality of life. Some participants may undergo a skin biopsy (a procedure in which a small skin sample is taken to check the effects of the treatment). Participants will also undergo high-resolution computed tomography scans to produce images of the lungs. Any new sores on the participants' fingers will be examined. Scans and other tests/examinations will be conducted to check for changes in lung function. Blood samples will be taken at each visit, and participants will be asked for urine samples. General health tests, physical examinations, and assessments to record heart activity will be conducted. Participants will be asked to inform the investigator or study staff about any changes in their health status.

(BASEC)

Malattie studiate

Systemic Sclerosis (SSc)

(BASEC)

Sponsor

Sponsor: Galderma Swiss Representative: PPD Switzerland GmbH

(BASEC)

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione etica Zurigo

(BASEC)

Data di approvazione del comitato etico

09.01.2026

(BASEC)

Risultati dello studio