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Study on Itacitinib for Adults with Diffuse Systemic Sclerosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Itacitinib in adults with a condition known as systemic sclerosis. Systemic sclerosis, also known as scleroderma, is a disease that causes the skin and connective tissues to harden and tighten. The study will compare the effects of Itacitinib to a placebo, which is a substance with no active medication, to see if Itacitinib can help reduce skin thickening in patients with this condition.

The purpose of the study is to determine if Itacitinib can decrease skin fibrosis, which is the thickening and scarring of connective tissue, in patients with diffuse systemic sclerosis. Participants in the study will take either Itacitinib or a placebo for a period of 360 days. The main goal is to observe changes in the skin's condition using a method called the modified Rodnan skin score, which measures the extent of skin thickening.

Throughout the study, researchers will also monitor the safety of Itacitinib, the activity of systemic sclerosis, and the overall quality of life and disability of the participants. This trial aims to provide valuable information on whether Itacitinib can be an effective treatment option for people living with systemic sclerosis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the itacitinib tablet, and the other group will receive a placebo tablet. This process ensures that the study results are unbiased.

  2. Step 2

    Medication administration

    If assigned to the itacitinib group, you will take a 100 mg tablet orally each day. If assigned to the placebo group, you will take a placebo tablet that looks identical to the itacitinib tablet. This will continue for a total of 360 days.

  3. Step 3

    Regular assessments

    Throughout the study, regular assessments will be conducted to monitor your health and the effects of the treatment. These assessments will include evaluations of skin condition using the modified Rodnan skin score, which measures skin thickness.

  4. Step 4

    Primary outcome evaluation

    The primary outcome of the study is to observe any changes in the modified Rodnan skin score after 360 days of treatment. This will help determine the effectiveness of itacitinib in reducing skin fibrosis.

  5. Step 5

    Secondary outcome evaluation

    Secondary outcomes will also be evaluated, including the safety profile of the treatment, the activity of systemic sclerosis, and the impact on quality of life and disability.

Who can join the trial?

9 criteria

  • Must be an adult, which means 18 years or older.
  • Must have a diagnosis of **Systemic Sclerosis (SSc)**, a condition affecting the skin and other organs, as defined by specific medical criteria.
  • Must have a type of SSc called **diffuse SSc**, according to a specific classification.
  • The disease duration should be less than 36 months, which means the time since the first symptoms appeared, or the disease should be active according to a specific activity score.
  • Must have a **modified Rodnan skin score (mRSS)** between 10 and 35 units. This score measures skin thickness.
  • Women who can have children must have a negative pregnancy test and use reliable birth control during the study.
  • Must be able to provide written consent, meaning you agree to participate in the study after understanding what it involves.
  • Must be affiliated with a social security scheme, meaning you have some form of health insurance or coverage.
  • If taking **mycophenolate** or **methotrexate** for SSc, the dose must be stable for at least 2 months before starting the study. These are medications used to treat SSc.

Who cannot join the trial?

1 criterion

  • Patients who do not have newly or active **diffuse Systemic sclerosis (SSc)** at the time of screening. **Diffuse Systemic sclerosis** is a condition that affects the skin and sometimes other organs, causing them to become thick and hard.
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Investigated drugs

Itacitinib is a medication being studied for its potential to reduce skin fibrosis in adults with systemic sclerosis. This trial aims to evaluate the safety and effectiveness of itacitinib over a period of 360 days. The goal is to see if itacitinib can improve the condition of the skin by decreasing the thickening and hardening that occurs in systemic sclerosis.

What is already known about the treatment

Itacitinib – Itacitinib is administered orally in tablet form. It is currently being studied in clinical trials for its potential use in treating systemic sclerosis, a condition characterized by skin fibrosis. The main therapeutic indication for itacitinib in this context is to reduce skin fibrosis in patients with diffuse systemic sclerosis. Itacitinib works by inhibiting specific enzymes known as Janus kinases (JAKs), which play a role in the inflammatory process and immune response. It belongs to the pharmacological class of JAK inhibitors.

Investigated diseases

Diffuse Systemic Sclerosis – Diffuse Systemic Sclerosis is a rare autoimmune disease characterized by the hardening and tightening of the skin and connective tissues. It primarily affects the skin but can also involve internal organs such as the heart, lungs, and kidneys. The disease progresses with the overproduction of collagen, leading to fibrosis and thickening of the skin. Patients may experience symptoms like skin stiffness, joint pain, and reduced mobility. As the condition advances, it can lead to complications in various organ systems. The severity and progression of symptoms can vary widely among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513648-27-00Protocol codeAPHP180613Estimated enrolment74 patientsSponsorAssistance Publique Hopitaux De Paris

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