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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliera di Padova Padua Italy
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
Johannes Wesling Klinikum Minden Minden Germany
Malopolskie Badania Kliniczne Sp. z o.o. Cracow Poland
Assistance Publique Hopitaux De Paris Paris France
University Of Pecs Pecs Hungary
Hopitaux Universitaires Pitie Salpetriere Paris France
University Of Debrecen Debrecen Hungary
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Centre Hospitalier Universitaire De Toulouse Toulouse France
Universita’ Campus Bio-medico Di Roma Rome Italy
Semmelweis University Budapest Hungary
Universita’ Politecnica Delle Marche Ancona Italy
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Universitair Ziekenhuis Gent Gent Belgium
Saint Maria Hospital Bucharest Romania
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Universita Degli Studi Di Brescia Brescia Italy
Universita’ Degli Studi Di Ferrara Ferrara Italy
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto Milan Italy
Hospital Universitario Dr Peset Aleixandre Valencia Spain
University Of Szeged Szeged Hungary
Hôpital Pontchaillou-CHU Rennes Rennes France
Budai Egeszsegkoezpont Zrt. Budapest Hungary
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Med Lodz Poland
Mehsskwcd Ifbtulcshi Cwrbnkct Sdyzkbeb Sur z oofn Warsaw Poland
Swpxtghp Cbbnsr db Rsqghbiiqz Ieoz Iasi Romania
Bsillxrgrs Imozisedfplo Bnoum Igvzjdfimcdjw Kmlfdr Budapest Hungary
Syvdckov Curxqi &slgxdnhre Iq Caplfwdwtyhkkadvkb Bucharest Romania
Wmhhrvgwgc Sfyriab Sszgrlblwhkjsis nk 5 imp śwl Bxepxrw w Sgwiyjiq Sosnowiec Poland
Aecejmtqlw Pykytugy Hjqroghc Dj Prwog Paris France
Atbjfwydq Ugv Amsterdam The Netherlands
Utzycamutbvcfboiooqaz Mfyjokbf Avm Munster Germany
Hwytaxzi Dl Lp Sdxuy Cird I Ssou Pio Barcelona Spain
Csugfu Hjlfjoomqbc Udaspnzesxcvx Rxvtc Reims France
Uugkwpkihq Drvop Sesuq Ds Rqiw Lj Sflgzcnv Rome Italy
Ujdkerpbkozb Mnevosb Cqsvfdn Gjxadvjbt Groningen The Netherlands
Cbocjkzj Hnsyjghpinfk Ujtvqtxlqciwr Dc Vvno Vigo Spain
Hembkzyv Uhbukazgyevts dv A Cbclzk A Coruna Galicia Spain
Hisriwgd Uhlvrkyhqvpthp Sqkgamzkpe &xjjusp Hxzocnk dd Hzugpbxgtfv STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
29.06.2023
Belgium Belgium
Not recruiting
29.06.2023
France France
Not recruiting
29.06.2023
Germany Germany
Not recruiting
29.06.2023
Hungary Hungary
Not recruiting
29.06.2023
Italy Italy
Not recruiting
29.06.2023
Poland Poland
Not recruiting
29.06.2023
Romania Romania
Not recruiting
29.06.2023
Spain Spain
Not recruiting
29.06.2023
The Netherlands The Netherlands
Not recruiting
29.06.2023

Trial locations

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.

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 ID:
2023-505976-31-00
Protocol code:
D3460C00002
NCT ID:
NCT05925803
Trial Phase:
Therapeutic confirmatory (Phase III)

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