Obinutuzumab in Systemic Sclerosis

NCT07842523 | Not Yet Recruiting Phase 2

• 3 other identifiers: APHP2308262025-524003-682025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if obinutuzumab is effective in systemic sclerosis

Conditions

Systemic Sclerosis in Adults

Keywords

Systemic sclerosis; obinutuzumab

Outcome Measures

Primary Outcomes (1)

• the percentage of patients achieving a 20% CRISS improvement from baseline in at least 3 of the 5-core set second step leasures if the Revised CRISS at 360 days.

  360 days

Secondary Outcomes (25)

• Mortality up to 360 days

  360 days

• Occurrence of Adverse Events up to 360 days

  At 90, 180, 270 and 360 days

• Occurrence of Severe Adverse Events up to 360 days

  At 90, 180, 270 and 360 days

• Occurrence of AE of specific interest previously mentioned

  At 90, 180, 270 and 360 days

• Proportion of patients who achieved CRISS20 of the revised CRISS

  At days 180 and 270

Study Arms (2)

Obinutuzumab

EXPERIMENTAL

1000mg of i.v obinutuzumab at D1, D15 and D180

Drug: Obinutuzumab

Placebo

PLACEBO COMPARATOR

1000mg of i.v placebo at D1, D15 and D180

Drug: Placebo

Interventions

Obinutuzumab DRUG

1000mg of i.v obinutuzumab at D1, D15 and D180

Obinutuzumab

Placebo DRUG

1000mg of i.v placebo at D1, D15 and D180

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 American College of Rheumatology / EULAR 2013 criteria,
• Patient with a diffuse SSc, as defined according to Leroy et al.
• Patient with a SSc disease duration of less than 8 years (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 during the treatment period and up to 18 months after stopping it Women are considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient
• 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
• \- Anti-fibrotic drugs such as nintedanib is permitted

You may not qualify if:

• Any B-cell depleting (e.g., anti-CD20, anti-CD19) or anti-plasma cell therapy such as, but not limited to, obinutuzumab, rituximab, ocrelizumab, ofatumumab, or bortezomib less than 9 months prior to screening or during screening. If anti-CD20 or anti-CD19 therapy has been received between 9 and 12 months prior to screening, the peripheral CD19+ B-cell count must be over 25 cells/μL
• Cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
• Any biologic therapy (other than 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 patients not fully vaccinated following national recommendations against SARS-CoV-2
• Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation
• HIV infection: for participants with unknown HIV status, HIV testing will be performed locally at screening if required by local regulations.
• Active infection of any kind, excluding fungal infection of the nail beds. Any major episode of infection that also fulfills any of the following criteria:
• Requires hospitalization during the 8 weeks prior to screening or during screening
• Requires treatment with IV antibiotics (or anti-infectives) during the 8 weeks prior to screening or during screening
• Requires treatment with oral antibiotics (or anti-infectives) during the 2 weeks prior to screening or during screening
• 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)

Hôpital Cochin

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

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

obinutuzumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Luc MOUTHON, MD / PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Central Study Contacts

Benjamin CHAIGNE, MD

CONTACT

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

Adèle BELLINO

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: August 3, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)