Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study of anifrolumab effectiveness compared to placebo in adults aged 18-70 with systemic sclerosis

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial studies the effectiveness of anifrolumab in treating Systemic Sclerosis, also known as SSc, a rare autoimmune disease that causes hardening of the skin and can affect internal organs. The study includes patients who have either limited or diffuse forms of the disease, and some participants may also have Interstitial Lung Disease, a condition that affects the lungs.

The study compares anifrolumab (MEDI-546) to placebo in adults with Systemic Sclerosis. The medication is given as a subcutaneous injection, which means it is administered under the skin. Participants may continue using their standard treatments during the study, including medications such as hydroxychloroquine, methotrexate, azathioprine, or mycophenolate mofetil.

The main goal of this research is to determine if anifrolumab works better than placebo in improving the signs and symptoms of Systemic Sclerosis. The study will measure changes in skin thickness, breathing function, daily activities, and overall well-being. The treatment period lasts for up to 104 weeks, during which participants will receive regular evaluations to monitor their response to the treatment and any potential side effects.

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

    Initial screening and evaluation

    Your eligibility for the study will be evaluated based on specific criteria, including age (18-70 years), body weight (up to 145 kg), and confirmation of systemic sclerosis diagnosis

    A physical examination will be performed to assess your skin condition using the Modified Rodnan Skin Score and to ensure there are suitable areas for injection

    Various health assessments will be conducted, including a questionnaire about your daily activities and a chest CT scan if needed

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either anifrolumab or placebo

    The treatment will be administered through subcutaneous injection (under the skin)

    You may continue taking your current medications including hydroxychloroquine, methotrexate, azathioprine, or other approved therapies

  3. Step 3

    Treatment period

    Regular assessments will track changes in your condition, including:

    Monitoring of your lung function

    Skin thickness measurements

    Evaluation of your daily activities and overall well-being

    Regular safety assessments and monitoring for any side effects

  4. Step 4

    Follow-up evaluations

    Your progress will be measured using several factors:

    Changes in lung function tests

    Improvements in skin thickness

    Your ability to perform daily activities

    Overall assessment of your condition by both you and your doctor

  5. Step 5

    Study completion

    The study is expected to continue until December 2027

    Long-term monitoring will assess the safety and effectiveness of the treatment

    Final evaluations will measure the overall impact of the treatment on your condition

Who can join the trial?

11 criteria

  • Age between 18 and 70 years old
  • Must be able to take stable background medications, which may include: - Hydroxychloroquine (medicine for autoimmune conditions) - Methotrexate (medicine that reduces inflammation) - Azathioprine (medicine that suppresses immune system) - Mycophenolate medications (medicines that prevent organ rejection) - Oral steroids - Tacrolimus (medicine that reduces immune system activity)
  • Must have clear, unaffected skin at injection sites
  • Women who can become pregnant must have a negative pregnancy test
  • Body weight must be less than or equal to 145.0 kg (319.7 lb)
  • Must have confirmed Systemic Sclerosis (SSc) diagnosis according to 2013 medical criteria
  • Must have either limited or diffuse skin involvement
  • Disease duration must be 6 years or less from first non-Raynaud's symptom
  • Must have either: - A certain level of disability measured by specific questionnaire (HAQ-DI score ≥ 0.25) or - A certain level of disease severity (Patient Global Assessment score ≥ 3)
  • Must have either: - Modified Rodnan Skin Score greater than 10 with disease less than 18 months, or - Diagnosis of lung disease shown on chest CT scan
  • If above skin criteria not met, must have: - Skin score of 15 or higher with disease longer than 18 months and - Active disease shown by blood tests or new skin involvement or presence of tendon friction

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Pregnancy or breastfeeding
  • Other autoimmune conditions besides Systemic Sclerosis (SSc)
  • Previous treatment with anifrolumab or similar medications
  • Severe or uncontrolled lung disease not related to SSc
  • Active infections or history of severe infections in the past 3 months
  • History of cancer within the past 5 years (except for successfully treated non-melanoma skin cancer)
  • Significant heart problems or uncontrolled high blood pressure
  • Severe kidney or liver disease
  • Current drug or alcohol abuse
  • Mental health conditions that could interfere with study participation
  • Participation in another clinical trial within the past 30 days
  • Known allergic reactions to study medications or their components
  • Use of medications that could interact with the study drug
  • Unable to follow study procedures or attend scheduled visits
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Anifrolumab is a medication being studied for treating systemic sclerosis (SSc), a rare autoimmune disease that causes hardening and tightening of the skin and connective tissues. This medication works by targeting a protein involved in the immune system response. It is given to patients alongside their standard therapy to help manage the signs and symptoms of systemic sclerosis. Standard therapy refers to the usual treatments that patients with systemic sclerosis may already be receiving for their condition, which can continue during the trial. These treatments may include medications to help manage specific symptoms of the disease.

What is already known about the treatment

Anifrolumab – A monoclonal antibody medication administered through intravenous infusion, specifically designed to treat autoimmune conditions including Systemic Sclerosis (SSc) and related interstitial lung disease. The drug works by targeting and blocking type I interferon receptors, which play a crucial role in the immune system's inflammatory response, thereby helping to reduce inflammation and prevent tissue damage. Currently undergoing Phase III clinical trials, this medication represents a promising therapeutic approach for patients with SSc, particularly those presenting with limited or diffuse cutaneous manifestations, and is being evaluated for its ability to improve signs and symptoms associated with the disease when used alone or in combination with standard therapy.

Investigated diseases

  • Systemic Sclerosis (SSc)

    A chronic autoimmune disease that causes hardening and tightening of the skin and connective tissues. It occurs when the body produces too much collagen, leading to tissue thickening. The condition can affect multiple body systems, including skin, blood vessels, and internal organs. SSc commonly begins with skin changes in the hands and face, and may progress to affect larger areas of the body. The disease can present in two main forms: limited cutaneous, where skin involvement is mainly restricted to hands, arms, and face, or diffuse cutaneous, where skin involvement is more widespread.

  • Interstitial Lung Disease (ILD)

    A group of disorders that cause inflammation and scarring of the lung tissue. The condition affects the interstitium, which is the tissue and space around the air sacs of the lungs. Over time, the scarring causes the lung tissue to become stiff, making it increasingly difficult to breathe. The scarring process typically develops gradually, causing progressive shortening of breath and dry cough.

  • Autoimmune Disease

    A condition where the body's immune system mistakenly attacks its own healthy cells and tissues. The immune system fails to recognize the body's normal cells as "self" and creates antibodies to attack them. These disorders can affect any part of the body, causing inflammation and tissue damage. The symptoms vary depending on which body parts are targeted by the immune system.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505976-31-00Protocol codeD3460C00002Estimated enrolment306 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.