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Tulisokibart in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease

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What is this study about?

This clinical trial is studying Systemic Sclerosis Associated with Interstitial Lung Disease, a condition in which the immune system causes hardening of the skin and can also lead to scarring in the lungs. The treatment being tested is tulisokibart (also called MK-7240/PRA023), given by vein as an infusion. The purpose of the study is to see how safe this medicine is and whether it may help people with this lung disease. Some participants will receive tulisokibart and others will receive placebo.

The study is planned to last about 50 weeks for each person. During the study, treatment is given at regular times, and health checks are done over the course of the trial to watch for side effects and other changes in health. The study also looks at lung function, which means how well the lungs move air in and out.

Who Can Join the Study?

  • Be an adult aged 18 years or older.
  • Have systemic sclerosis according to the 2013 ACR/EULAR definition. This means the study doctor must confirm the diagnosis using set medical criteria.
  • Have had the first symptom of systemic sclerosis, other than Raynaud symptom (episodes where fingers or toes change color because of reduced blood flow), within the last 5 years before screening.
  • Have diffuse cutaneous scleroderma, meaning skin thickening in areas above the elbows or knees, but not just on the face and neck.
  • Have a total mRSS score between 10 and 35. The mRSS is a skin score used by doctors to measure how much the skin is thickened.
  • Have interstitial lung disease related to systemic sclerosis with fibrotic changes in the lungs, confirmed by a high-resolution CT scan (HRCT, a detailed lung scan), affecting at least 10% of the lungs.
  • Have forced vital capacity (FVC, the amount of air you can breathe out after taking a deep breath) of at least 45% of the expected normal value.
  • Have diffusing capacity of the lung for carbon monoxide (DLCO, a test that shows how well oxygen passes from the lungs into the blood) of at least 45% of the expected normal value, after correcting for hemoglobin, the oxygen-carrying part of blood.
  • Have at least one of the following signs of inflammation or disease activity: C-reactive protein (CRP, a blood test for inflammation) above the normal limit, erythrocyte sedimentation rate (ESR, another blood test for inflammation) above 28 mm/hr, or a positive anti-topoisomerase (anti-Scl-70) antibody test.
  • If using background treatment, meet the required stability rules: take only one of the allowed medicines, such as mycophenolate mofetil up to 3 g/day, methotrexate up to 25 mg/week, or azathioprine up to 150 mg/day, for at least 4 months before randomization and stay on a stable dose for the last 4 weeks before randomization.
  • If using nintedanib, have taken it for at least 6 months and been on a stable dose for at least 4 weeks before randomization, with no improvement in FVC after starting nintedanib.
  • If taking oral corticosteroids (steroid medicines by mouth), be on a stable dose of 10 mg/day or less of prednisone equivalent for at least 2 weeks before randomization. Inhaled and topical corticosteroids are allowed.
  • If female and able to become pregnant, not be pregnant or breastfeeding.
  • If female and able to become pregnant, use an acceptable contraceptive method or practice long-term and consistent abstinence from penile-vaginal sex from at least 4 weeks before the first study dose, during the study, and for at least 14 weeks after the last dose.
  • If female and able to become pregnant, have a negative pregnancy test before starting the study.
  • Have medical history, menstrual history, and recent sexual activity reviewed by the study doctor to lower the chance of an early pregnancy that was not yet detected.
  • Be able to give written informed consent, which means signing a form showing you understand the study and agree to take part.
  • Be able to understand and follow the study rules and requirements.

Who Cannot Join the Study?

  • Any history of cancer within the last 5 years, except for non-melanoma skin cancer that has been fully removed, or cervical carcinoma in situ / localized cervical cancer that was treated with surgery and fully removed.
  • Any non-melanoma skin cancer that is still present and has not been removed before joining the study.
  • Active tuberculosis (TB), which is a serious infection that usually affects the lungs, or meeting any study rules that exclude people with TB risk.
  • Long-lasting or repeated infections, such as chronic pyelonephritis (ongoing kidney infection), osteomyelitis (bone infection), or bronchiectasis (permanent widening of the airways that can lead to repeated lung infections).
  • Any active infection, except for fungal infection of the nail bed, including infections that need IV treatment, which means medicine given into a vein, or IM treatment, which means medicine given into a muscle, within 4 weeks before randomization.
  • Any active infection that needed oral antibiotics, which are medicines taken by mouth, within 2 weeks before randomization.
  • Known infection with HBV (hepatitis B virus, a virus that infects the liver).
  • Known infection with HCV (hepatitis C virus, a virus that infects the liver).
  • Known infection with HIV (human immunodeficiency virus, a virus that weakens the immune system).
  • Positive HBsAg test, which means there is evidence of current hepatitis B infection.
  • Negative HBsAg but positive HBcAb with HBV-DNA at or above the allowed level. HBcAb is a blood test that can show past hepatitis B infection, and HBV-DNA means the amount of hepatitis B virus genetic material in the blood.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Budai Irgalmasrendi Korhaz Nonprofit Kft. Budapest Hungary
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Centrum Medyczne Oporow Wroclaw Poland
Szpital Specjalistyczny Nr I W Bytomiu SPZOZ Bytom Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
University Of Debrecen Debrecen Hungary
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Kerckhoff-Klinik GmbH Bad Nauheim Germany
University Of Pecs Pecs Hungary
Hopital Beaujon Clichy France
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
Plrng Dbr mrit Gzkbcnn Nmxoc Mko Gubd Bad Doberan Germany
Nxfrgifk Iirlzyhg Gicyuzoyo Rrbrdldwhwzh I Rvpckoxshcmbg It Pfxch Dv Hupq Mawx Eeffjrzk Rxlakmk Warsaw Poland
Ucufwxlmyr Hpclohwx Cophqvb Cologne Germany
Ssbyvshsm Rgpilmt Uvhlewhknm Mudfriz Cmijqo Nijmegen The Netherlands
Ayladkx Onxjcrxgfry Ubfaqueiizmow Cxkmgbjpxelv Deodu Silqkv E Dkvrf Sgiyikx Do Thjyxo Turin Italy
Aeyvwal Ugf Idjmq Dl Rwzcgd Easskb Reggio Emilia Italy
Hurbvnlg Dw Lk Szpnh Cdzp I Siwd Pto Barcelona Spain
Uzlwgxdpdc Deqio Srtwa Dw Roaa Lb Spnpjfns Rome Italy
Hudinbgw Vovr dytikzre Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
20.09.2022
France France
Not recruiting
20.09.2022
Germany Germany
Not recruiting
20.09.2022
Hungary Hungary
Not recruiting
20.09.2022
Italy Italy
Not recruiting
20.09.2022
Poland Poland
Not recruiting
20.09.2022
Spain Spain
Not recruiting
20.09.2022
The Netherlands The Netherlands
Not recruiting
20.09.2022

Trial locations

Investigated drugs:

tulisokibart is the study medicine being tested in this trial. It is given through a vein as an infusion. The goal is to see whether it is safe and well tolerated, and whether it can help slow down the loss of lung function in people with systemic sclerosis-associated interstitial lung disease.

Systemic sclerosis associated with interstitial lung disease – A form of systemic sclerosis in which the lungs become involved with scarring and inflammation in the tissue around the air sacs. It usually begins as a gradual worsening of skin-related sclerosis along with slow damage to the lungs. Over time, the lung tissue becomes stiffer, which can reduce how well the lungs expand and exchange air. The condition may progress at different speeds, with periods of relative stability and periods of worsening.

Trial ID:
2023-509743-27-00
Protocol code:
PR200-104_MK-7240-00
NCT ID:
NCT05270668
Trial Phase:
Therapeutic exploratory (Phase II)

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