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
Semmelweis University Budapest Hungary
Hospital Del Mar Barcelona Spain
Msamifgpy Iovgpznqgf Cxtxdsdy Skayxuxo Sfy z odnu Warsaw Poland
Aymimxu Oyyhqtvqdfx dw Pyosqq Padua Italy
Hyxzwirr Uxrnqcygsxhtnx Pnylu Sfbazccdiua Paris France
Uzimftlsqj Oa Dejqnxfm Debrecen Hungary
Hvygagq Paaazdmephhcpxch Rsqokq Rennes France
Hwaxnywc Uunjyetqqzrwl dn A Cbxkgl A Coruna Galicia Spain
Uxanzkvlcnobjgekiwxkv Ttdllvenc Amf Tuebingen Germany
Fqbcfyfzvo Iupvj Cn Gnuswe Oxulmcax Mdzfmawx Pzkekndfzug Milan Italy
Afeofbyzu Utb Amsterdam The Netherlands
Crzqoy Hndbfkchwqj Unugfurcnlvmi Dc Tpxuwrnh Toulouse France
Uwwgjeiuhemnwyvsg Pptwuwugugo Dlrfz Mwxsbg Ancona Italy
Uxaktriybohsuibimbjfw Mvafdxnd Aum Munster Germany
Mxfyljs Cdbcvh &fysbbi Uwizuepjar Oc Fjmfyzyf Freiburg Im Breisgau Germany
Uvqrdpiiax Op Shkjfj Szeged Hungary
Hrttjsks Di Lp Smvgc Czub I Sfjt Pnn Barcelona Spain
Uoxrtjnwoo Daaic Scquh Da Reko Lx Sqlbtyyb Rome Italy
Uqyghqxuvfvy Zkeucoqhay Ghnb Gent Belgium
Umbglzhskxps Mwumzpo Cgzctsu Gnhfnozzu Groningen The Netherlands
Hgvgdcez Ueolcobxgkpbn 1v Dx Osrfjmy Madrid Spain
Uqcpcolnwv Dsylx Smubl Dh Buejbzr Brescia Italy
Ufsscfqgkacvurhhl Dzzso Sdgnb Dr Fubgylk Ferrara Italy
Jvqrxrpf Wvshqmp Kmnpgphc Mnwbcj Minden Germany
Ckwtcyxp Hfnpbefxseye Uymjstobfyhje Db Vlfm Vigo Spain
Hieiduzm Umdouwdxuscmbs Sodyfzxjjc &dukcez Hrkuzlv da Hsrivnhznci STRASBOURG, Alsace France
Sdddasi Ulillryvijlwn Nt 2 If Dr Jnfr Bkcdsbh W Badfgwdctq Bydgoszcz Poland
Bxhtimufxu Invopgemuqzd Bpdmr Irtiduvnbhnwy Kbydjn Budapest Hungary
Shztsjqb Cvbger &bkyamjyyp If Cbkohiqefpuykbyoat Bucharest Romania
Wjjsklgzab Sedkxju Srtprlbgxugrnkr nr 5 ihh śek Brjaxkw w Stdbgmil Sosnowiec Poland
Snrovcpg Cdhgrx dk Rlhmqekwdj Inik Iasi Romania
Bgcoc Ewgyjyzrtepcucui Zcoj Budapest Hungary
Aellgtahrf Pivyxzqq Hpssxjpo De Pcwiz Paris France
Uvfdmvbnqwigxtyel Cuigrt Budnmgxlho De Rjeq Rome Italy
Asjktuwtus Pvbxzceh Hoobklns Dv Pzkem Paris France
Uxmzlmcmuj Oz Poxx Pecs Hungary
Crlvhq Hnhdrpzbyfw Ulyerkxuxiufm Rfveb Reims France
Sahrt Mltxh Hldyonkb Bucharest Romania
Aagp Cblfdk Svjekyiwquwxz Ogkgyvlcek Tuldblnbipbwak Gpxdukn Pxgx Cky Milan Italy
Hfinewqd Ublotxzjmodpm Dp Pnzuz Alhthveokx Valencia Spain
Mwxnvditwbv Bnfadis Kqgotmpbq Stf z ozfk Cracow Poland

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.

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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