Rituximab vs Placebo for Maintenance in Systemic Sclerosis - Interstitial Lung Disease

NCT07827742 | Not Yet Recruiting Phase 2

• 3 other identifiers: APHP2409092025-521331-36-002025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Rituximab is safe and effective as a maintenance strategy in individuals with stabilized systemic sclerosis in adults.

Conditions

Systemic Sclerosis in Adults

Keywords

Systemic sclerosis; Rituximab

Outcome Measures

Primary Outcomes (1)

• changes in forced vital capacity (FVC) from baseline to Month 18 of randomisation.

  PFTs: changes in forced vital capacity (FVC)

  18 months

Secondary Outcomes (35)

• Mortality up to 18 months

  18 months

• Occurrence of Adverse Events

  At 6, 12 and 18 months

• Occurrence of Adverse Events

  At 6, 12 and 18 months

• Occurrence of AE of specific interest previously mentioned at 6, 12 and 18 months

  At 6, 12 and 18 months

• Change in gammaglobulin, lymphocytes and CD19 levels at 6, 12 and 18 months

  At 6, 12 and 18 months

Study Arms (2)

Rituximab

EXPERIMENTAL

500mg of i.v rituximab at M0, M6 and M12

Drug: Rituximab

Placebo

PLACEBO COMPARATOR

500mg of i.v placebo at M0, M6 and M12

Drug: Placebo

Interventions

Rituximab DRUG

500mg i.v at M0, M6 and M12

Rituximab

Placebo DRUG

500mg i.v at M0, M6 and M12

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient (≥ 18 years old),
• Patient with a diagnosis of SSc, as defined by the ACR/EULAR 2013 criteria (cf. Table 2) (6)
• Patient with ILD identified on the basis of a HRCT, obtained within 12 months before screening, that showed fibrosis affecting at least 10% of the lungs,
• SSc-ILD induction with RTX, either twice 1000 mg two weeks apart, or 375 mg/m2 four times 4 weeks apart.
• The interval between the last induction dose and the first maintenance dose should be 6 months +/- 15 days.
• Patient with stabilized SSc-ILD following RTX induction treatment as defined by the absence of worsening respiratory symptoms, an absolute decline of FVC of \< 5% of the predicted value, an absence of absolute decline of DLCO (corrected for hemoglobin) of \< 10% related to SSc-ILD, and absence of radiological evidence of disease progression on HRCT(97)
• All required vaccinations must have been carried out at least 4 weeks before D0. According to recommendations, prophylaxis against pneumocystis is recommended for scleroderma, but not mandatory.
• Woman of childbearing potential should have reliable contraception\* for the 12 months' duration of the study's treatment and 12 months after last administration,
• Patient able to give written informed consent prior to participation in the study,
• Affiliation to a social security scheme (profit or being entitled). AME is not accepted.

You may not qualify if:

• Forced vital capacity \< 40% of the predicted value
• Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) \< 30% of the predicted value.
• Contra-indication or anaphylaxis toward RTX
• Contra-indication to auxiliary medicinal products
• Cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
• Any biologic therapy (including other anti-CD20, anti-CD19, or anti-plasma cell) such as, but not limited to, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept during the 2 months prior to screening or during screening
• Inhibitors of Janus-associated kinase (JAK), Bruton's tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2), including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib or any investigational agent during the 2 months prior to screening or during screening
• Any live vaccine during the 28 days prior to screening or during screening
• High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions during the 28 days prior the screening
• Active infection with SARS-CoV-2 or absence of COVID-19 vaccination within the last six months (this criteria will be updated at the time of submission to European Agency to be in adequation with national recommendation at the time of submission).
• Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation
• HIV infection : for participants with unknown HIV status (if the previous tests date more than 3 months), HIV testing will be performed locally at screening.
• Active infection of any kind, excluding fungal infection of the nail beds.
• History of serious recurrent or chronic infection
• History of progressive multifocal leukoencephalopathy (PML)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin Hospital

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Luc MOUTHON, MD, PhD

  AP-HP - Hôpital Cochin 27 Rue du Faubourg Saint Jacques 75014 France

  STUDY CHAIR

Central Study Contacts

Benjamin CHAIGNE, MD

CONTACT

01 58 41 41 17; benjamin.chaigne@aphp.fr

Adèle BELLINO, PHD

CONTACT

01 71 76 07 57; adele.bellino@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: September 18, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): March 1, 2031
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)