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Systemic SclerosisPhase 2SCLERITANCT04789850

Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis

A Phase 2 study testing Itacitinib in people with Systemic Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 46 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to determine whether itacitinib is safe and effective in the treatment of systemic sclerosis in adults. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Sclerosis
What is being tested?
Itacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
46 sitesFrance
Study dates
2 Feb 2023to Feb 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patient (≥18 years old)
  • Patient with a diagnosis of diffuse SSc, as defined by the American College of Rheumatology / EULAR 2013 criteria,
  • Patient with a diffuse SSc, according to Leroy and Medsger dichotomy
  • Patient with a SSc disease duration of less than 36 months (defined as time from first non-Raynaud phenomenon manifestation) or with an active SSc disease, as defined by EUSTAR disease activity score,
  • Patient with a modified Rodnan skin score (mRSS) ≥ 10 and ≤ 35 units at screening,
  • Negative pregnancy test for woman of childbearing potential, woman of childbearing potential should have reliable contraception for the 12 months' duration of the study,
Show all 11Show fewer
  • Patient able to give written informed consent prior to participation in the study,
  • Affiliation to a social security scheme (profit or being entitled)
  • If patients receive mycophenolate or methotrexate for SSc, these need to be on stable dose as follows:
  • Mycophenolate mofetil/sodium: stable dose for at least 2 months prior to randomisation
  • Methotrexate: stable dose and route of administration for at least 2 months prior to randomisation

Who cannot join

  • Previous treatment with itacitinib or a Janus kinase (JAK) inhibitor,
  • Contra-indications to itacitinib or Janus kinase inhibitor,
  • Failure to sign the informed consent or unable to consent
  • Patient participating in another investigational therapeutic study,
  • Acute or chronic active infections, including HBV, HCV, HIV,
  • Patient with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,
Show all 18Show fewer
  • Patient suspected not to be observant to the proposed treatments,
  • Patient who have white blood cell count ≤ 4,000/mm3,
  • Patient who have platelet count ≤ 100,000/mm3,
  • Patients who have ALT or AST level greater that 3 times the upper limit of normal,
  • Patient who have triglyceride level greater than 5g/L
  • Pregnant or breastfeeding woman,
  • Protected adults (including individual under guardianship by court order),
  • Patient receiving or having received cyclophosphamide or rituximab within the last three months (possible inclusion beyond 3 months),
  • Patient receiving or having received a biotherapy (anti-TNF, abatacept or tocilizumab) in the last 3 months (possible inclusion beyond 3 months)
  • Patient with Systemic Lupus, or Sjögren's syndrome with systemic manifestations justifying immunosuppressive therapy
  • Atherosclerotic cardiovascular disease as defined by a history of myocardial infarction, ischaemic stroke, or peripheral artery thrombosis
  • Anti-phospholipid syndrome

Trial locations and contacts

46 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Benjamin Chaigne, MD contact

+33 1 58 41 41 17

benjamin.chaigne@aphp.fr

Adèle BELLINO contact

+33 1 58 41 11 95

adele.bellino@aphp.fr

46 sites in 1 country

France46 sites, 46 recruiting

  • CH Amiens

    Amiens, 80000

    Catherine LOK, MD, PhD

    Recruiting

  • CHU Angers

    Angers, 49100

    Christian LAVIGNE, MD

    Recruiting

  • CHU Annecy

    Annecy, 74370

    Alice BEREZNE, MD

    Recruiting

  • CHU Besançon

    Besançon, 25030

    Nadine MAGY-BERTRAND, MD, PhD

    Recruiting

  • Avicenne Hospital

    Bobigny, 93022

    Yurdagul UZUNHAN, MD, PhD

    Recruiting

  • CHU Bordeaux

    Bordeaux, 33000

    Marie-Elise TRUCHETET, MD

    Recruiting

  • CHU Bordeaux

    Bordeaux, 33000

    Joel CONSTANS, MD, PhD

    Recruiting

  • Ambroise Paré hospital

    Boulogne-Billancourt, 92100

    Laetitia COUTTE, MD

    Recruiting

  • Hôpital de la Cavale Blanche

    Brest, 29200

    Claire DE MOREUIL, MD

    Recruiting

  • CHU Caen

    Caen, 14000

    Achille AOUBA, MD, PhD

    Recruiting

  • CHU Gabriel Montpied

    Clermont-Ferrand, 63000

    Marc ANDRE, MD, PhD

    Recruiting

  • Henry Mondor hospital

    Créteil, 94000

    Nicolas LIMAL, MD

    Recruiting

  • CH Dax-Côte d'ARgent

    Dax, 40100

    François LIFERMANN, MD

    Recruiting

  • CHU Dijon

    Dijon, 21000

    Martin NIVET, MD

    Recruiting

  • CHU Grenoble

    Grenoble, 38700

    Bernard IMBERT, MD

    Recruiting

  • CHU Grenoble

    Grenoble, 38700

    Laurence BOUILLET, MD, PhD

    Recruiting

  • CH Le Mans

    Le Mans, 72037

    Paul LEGENDRE, MD

    Recruiting

  • CHU Lille

    Lille, 59000

    Eric HACHULLA, MD, PhD

    Recruiting

  • CHU Limoges

    Limoges, 87000

    Sylvain PALAT, MD, PhD

    Recruiting

  • CHU Lyon sud

    Lyon, 69310

    Jean-christophe LEGA, MD, PhD

    Recruiting

  • Hôpital Nord

    Marseille, 13015

    Brigitte GRANEL, MD, PhD

    Recruiting

  • La Timone Hospital

    Marseille, 13385

    Marie-Aleth RICHARD, MD, PhD

    Recruiting

  • La Timone Hospital

    Marseille, 13385

    Nicolas SCHLEINITZ, MD, PhD

    Recruiting

  • Robert Schuman Hospital

    Metz, 57000

    Juilien CAMPAGNE, MD

    Recruiting

  • CHU Montpellier - rhumatology

    Montpellier, 34090

    Jacques MOREL, MD, PhD

    Recruiting

  • CHU Montpellier - St Eloi Hospital

    Montpellier, 34090

    Philippe GUILPAIN, MD, PhD

    Recruiting

  • CHU Nancy

    Nancy, 54035

    Denis WAHL, MD

    Recruiting

  • CHU Nantes

    Nantes, 44093

    Christian AGARD, MD, PhD

    Recruiting

  • Hopital L'Archet 1

    Nice, 06000

    Nihal MARTIS, MD

    Recruiting

  • Hospital Pasteur - CHU Nice

    Nice, 06000

    Viviane QUEYREL, MD

    Recruiting

  • Saint Antoine Hospital

    Paris, 75012

    Sébastien RIVIERE, MD

    Not yet recruiting

  • La Pitié-Salpêtrière

    Paris, 75013

    Patrice CACOUB, MD

    Recruiting

  • La Pitié-Salpêtrière

    Paris, 75013

    Zahir AMOURA, MD, PhD

    Recruiting

  • Cochin Hospital

    Paris, 75014

    Benjamin Chaigne, MD, +33 1 58 41 41 17, benjamin.chaigne@aphp.fr

    Yannick ALLANORE, MD

    Recruiting

  • Hospital Croix St Simon

    Paris, 75020

    Jonathan LONDON, MD

    Not yet recruiting

  • CHU Poitiers

    Poitiers, 86021

    Mickael MARTIN, MD, PhD

    Recruiting

  • CH de Cornouaille

    Quimper, 29000

    Jérémy KERAEN, MD

    Recruiting

  • Robert Debré Hospital

    Reims, 51100

    Amélie SERVETTAZ, MD

    Recruiting

  • Hôpital Sud

    Rennes, 35200

    Alain LESCOAT, MD, PhD

    Recruiting

  • CHU Rouen

    Rouen, 76000

    Ygal BENHAMOU, MD, PhD

    Not yet recruiting

  • CHU Saint Etienne

    Saint-Etienne, 42000

    Lucile GRANGE, MD

    Recruiting

  • Nouvel Hospital Civil

    Strasbourg, 67000

    Thierry MARTIN, MD, PhD

    Recruiting

  • Rangueil Hospital

    Toulouse, 31400

    Grégory PUGNET, MD

    Recruiting

  • CHU Tours

    Tours, 37000

    Marie-Charlotte BESSE, MD

    Recruiting

  • CH Valenciennes

    Valenciennes, 59300

    Thomas QUEMENEUR, MD

    Recruiting

  • Hôpitaux de Barbois

    Vandœuvre-lès-Nancy, 54500

    Paul DECKER, MD

    Recruiting

Other trials in France

About this study

Official title: Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis: a Phase II, Randomized, Controlled Trial

The purpose of this study is to determine whether itacitinib is safe and effective in the treatment of systemic sclerosis in adults.

Read the detailed description

Systemic sclerosis (SSc) is a rare systemic autoimmune connective tissue-disease characterized by fibrosis, inflammation, and vasculopathy. SSc is responsible for skin fibrosis that can either be limited or diffuse. The latter phenotype of the disease is commonly associated with visceral involvement and therefore similar to graft versus host disease (GvHD) reaction. It can be life threatening in case of pulmonary or cardiovascular involvement. Nonetheless SSc remains a severe disease responsible for important disability and a poor quality of life.

There is a growing body of evidence that supports the implication of the JAK-STAT tyrosine kinases pathway in the activation of fibroblasts of patients with SSc. A genetic polymorphism of STAT4 was found to be associated with the diffuse form of the disease and inhibition of STAT4 gene is associated with a decrease in TGF-ß and IL-6 cytokines activation, which are two major cytokines implicated in SSc pathogenesis. Recently, Pedroza et al. confirmed the implication of STAT3 in skin fibrosis mechanisms. Indeed, the authors showed an enhanced activation of STAT3 and demonstrated in vivo that the inhibition of STAT3 phosphorylation prevented skin fibrosis in a murine model of SSc. These data were confirmed by a work of Zhang et al. who showed that the inhibition of JAK1 was also needed to prevent skin and lung fibrosis. Altogether these works confirmed the implication of the JAK pathway in fibrosis mechanism.

Itacitinib is a Janus kinase inhibitor that specifically targets JAK1 and decreases STAT3 phosphorylation. Itacitinib was shown to efficiently treat patients with myelofibrosis, rheumatoid arthritis, and chronic plaque psoriasis. Very interestingly, itacitinib efficacy has also been reported in patients with acute GvHD. Altogether these data and studies reinforced the investigator's working hypothesis.

The efficacy and safety of this proposal must be tested.

Being tested
Itacitinib, Placebo
Keywords
Systemic sclerosis, Itacitinib
Medical subject headings
Scleroderma, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ItacitinibDrug

    200 mg oral for 360 days

  • PlaceboDrug

    200 mg oral for 360 days

Study groups in NCT04789850
Study groupRoleWhat they receive
ItacitinibExperimental200mg of oral Itacitinib everyday for 360 days.
Receives: Drug: Itacitinib
PlaceboPlacebo comparatorOral placebo everyday for 360 days.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in modified Rodnan skin score (mRSS) at 360 days

    performed by the same investigator at day 0 and day 360 and the change in mRSS will be calculated following the formula: ΔmRSS= mRSSd360 - mRSSd0.

    To measure mRSS, skin thickness of the patient is rated by palpation at each of 17 anatomic sites using a scale of 0-3 (0 = normal skin; 1= mild thickness; 2= moderate thickness; 3=severe thickness with an inability to pinch the skin into a fold). The scores at each site are summed with a minimum of 0 and a maximum of 51 (17 sites)

    Measured: 360 days

Secondary outcomes (11)

  1. Incidence of death

    Measured: at 180 and 360 days

  2. Incidence of Adverse Events

    according to the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading scale

    Measured: at 180 and 360 days

  3. Incidence of Severe Adverse Events

    according to the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading scale

    Measured: at 180 and 360 days

  4. Change in modified Rodnan skin score at 90, 180, 270 days

    Measured: at 90, 180 and 270 days

  5. Proportion of patients who improved mRSS at 90, 180, 270 and 360 days

    Measured: At 90, 180, 270 and 360 days

  6. Proportion of patients with an active disease according to the European scleroderma trials and research group (EUSTAR)SSc activity score at 90, 180, 270 and 360 days

    EUSTAR SSc activity index score from 0 to 10 - a cut-off ≥ 2.5 identifies patients with active disease

    Measured: At 90, 180, 270 and 360 days

  7. Change in the Combined Response Index in Diffuse Systemic Sclerosis (CRISS) score

    composite response index

    Measured: At 180 and 360 days

  8. SSc disease activity

    • Physicians visual analogue scale range from 0 (min) to 10 (max) - 0=no activity, 10=maximum activity
    • Patients visual analogue scale range from 0 (min) to 10 (max) - 0=no activity, 10=maximum activity

    Measured: At 90, 180, 270 and 360 days

  9. Short Form-36 (SF-36) health questionnaire

    self-administered questionnaire of 36 items assessing the following 8 domains : physical functioning, bodily pain, role limitations attributable to physical health problems, general health perceptions, mental health, role limitations to emotional problems, vitality and social functioning (scale from 0 to 100)

    Measured: At 0, 15, 90, 180, 270 and 360 days

  10. EurolQol-5Domain (EQ-5D) health questionnaire

    self reported measure of quality of life - (scale from 0 to 100)

    Measured: At 0, 15, 90, 180, 270 and 360 days

  11. Health Assessment Questionnaire Disability Index (HAQ-DI) scale

    self administered 20 questions- score range from 0 (no disability) to 3 (severe disability)

    Measured: At 0, 15, 90, 180, 270 and 360 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2021
  2. Study start2 Feb 2023
  3. Primary completionFeb 2026 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04789850
Sponsor's protocol ID
APHP180613
Other IDs
2019-003430-16, 2019
Acronym
SCLERITA
Status last verified
Oct 2025
First submitted
10 Feb 2021
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Almeida C, Almeida I, Vasconcelos C. Quality of life in systemic sclerosis. Autoimmun Rev. 2015 Dec;14(12):1087-96. doi: 10.1016/j.autrev.2015.07.012. Epub 2015 Jul 23.

    PubMed 26212726

  • Mouthon L. SSc in 2011: From mechanisms to medicines. Nat Rev Rheumatol. 2012 Jan 10;8(2):72-4. doi: 10.1038/nrrheum.2011.203.

    PubMed 22231235

  • Distler JH, Feghali-Bostwick C, Soare A, Asano Y, Distler O, Abraham DJ. Review: Frontiers of Antifibrotic Therapy in Systemic Sclerosis. Arthritis Rheumatol. 2017 Feb;69(2):257-267. doi: 10.1002/art.39865. No abstract available.

    PubMed 27636741

  • Wang Y, Fan PS, Kahaleh B. Association between enhanced type I collagen expression and epigenetic repression of the FLI1 gene in scleroderma fibroblasts. Arthritis Rheum. 2006 Jul;54(7):2271-9. doi: 10.1002/art.21948.

    PubMed 16802366

  • Landi C, Bargagli E, Bianchi L, Gagliardi A, Carleo A, Bennett D, Perari MG, Armini A, Prasse A, Rottoli P, Bini L. Towards a functional proteomics approach to the comprehension of idiopathic pulmonary fibrosis, sarcoidosis, systemic sclerosis and pulmonary Langerhans cell histiocytosis. J Proteomics. 2013 May 27;83:60-75. doi: 10.1016/j.jprot.2013.03.006. Epub 2013 Mar 23.

    PubMed 23528693

  • Kubo M, Ihn H, Yamane K, Tamaki K. Up-regulated expression of transforming growth factor beta receptors in dermal fibroblasts in skin sections from patients with localized scleroderma. Arthritis Rheum. 2001 Mar;44(3):731-4. doi: 10.1002/1529-0131(200103)44:33.0.CO;2-U. No abstract available.

    PubMed 11263790

  • Zhang Y, Liang R, Chen CW, Mallano T, Dees C, Distler A, Reich A, Bergmann C, Ramming A, Gelse K, Mielenz D, Distler O, Schett G, Distler JHW. JAK1-dependent transphosphorylation of JAK2 limits the antifibrotic effects of selective JAK2 inhibitors on long-term treatment. Ann Rheum Dis. 2017 Aug;76(8):1467-1475. doi: 10.1136/annrheumdis-2016-210911. Epub 2017 May 6.

    PubMed 28478401

  • Migita K, Izumi Y, Torigoshi T, Satomura K, Izumi M, Nishino Y, Jiuchi Y, Nakamura M, Kozuru H, Nonaka F, Eguchi K, Kawakami A, Motokawa S. Inhibition of Janus kinase/signal transducer and activator of transcription (JAK/STAT) signalling pathway in rheumatoid synovial fibroblasts using small molecule compounds. Clin Exp Immunol. 2013 Dec;174(3):356-63. doi: 10.1111/cei.12190.

    PubMed 23968543

  • Xu Y, Wang W, Tian Y, Liu J, Yang R. Polymorphisms in STAT4 and IRF5 increase the risk of systemic sclerosis: a meta-analysis. Int J Dermatol. 2016 Apr;55(4):408-16. doi: 10.1111/ijd.12839. Epub 2015 Dec 29.

    PubMed 26712637

  • Avouac J, Furnrohr BG, Tomcik M, Palumbo K, Zerr P, Horn A, Dees C, Akhmetshina A, Beyer C, Distler O, Schett G, Allanore Y, Distler JH. Inactivation of the transcription factor STAT-4 prevents inflammation-driven fibrosis in animal models of systemic sclerosis. Arthritis Rheum. 2011 Mar;63(3):800-9. doi: 10.1002/art.30171.

    PubMed 21360510

  • Kremer JM, Bloom BJ, Breedveld FC, Coombs JH, Fletcher MP, Gruben D, Krishnaswami S, Burgos-Vargas R, Wilkinson B, Zerbini CA, Zwillich SH. The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: Results of a double-blind, placebo-controlled phase IIa trial of three dosage levels of CP-690,550 versus placebo. Arthritis Rheum. 2009 Jul;60(7):1895-905. doi: 10.1002/art.24567.

    PubMed 19565475

  • Fridman JS, Scherle PA, Collins R, Burn T, Neilan CL, Hertel D, Contel N, Haley P, Thomas B, Shi J, Collier P, Rodgers JD, Shepard S, Metcalf B, Hollis G, Newton RC, Yeleswaram S, Friedman SM, Vaddi K. Preclinical evaluation of local JAK1 and JAK2 inhibition in cutaneous inflammation. J Invest Dermatol. 2011 Sep;131(9):1838-44. doi: 10.1038/jid.2011.140. Epub 2011 Jun 16.

    PubMed 21677670

  • Deverapalli SC, Rosmarin D. The use of JAK inhibitors in the treatment of progressive systemic sclerosis. J Eur Acad Dermatol Venereol. 2018 Aug;32(8):e328. doi: 10.1111/jdv.14876. Epub 2018 Mar 6. No abstract available.

    PubMed 29444362

  • Gordon JK, Martyanov V, Franks JM, Bernstein EJ, Szymonifka J, Magro C, Wildman HF, Wood TA, Whitfield ML, Spiera RF. Belimumab for the Treatment of Early Diffuse Systemic Sclerosis: Results of a Randomized, Double-Blind, Placebo-Controlled, Pilot Trial. Arthritis Rheumatol. 2018 Feb;70(2):308-316. doi: 10.1002/art.40358. Epub 2017 Dec 29.

    PubMed 29073351

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Itacitinib in people with Systemic Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 46 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Benjamin Chaigne, MD (+33 1 58 41 41 17, benjamin.chaigne@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in modified Rodnan skin score (mRSS) at 360 days (time frame: 360 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04789850, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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