Health TrialsbyHealthPanel

Obinutuzumab in Systemic Sclerosis

ConditionSystemic Sclerosis in Adults
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Obinutuzumab

    Drug

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

  • Placebo

    Drug

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: ObinutuzumabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
360 days

Secondary outcomes

1

Mortality up to 360 days

Time frame
360 days
2

Occurrence of Adverse Events up to 360 days

Time frame
At 90, 180, 270 and 360 days
3

Occurrence of Severe Adverse Events up to 360 days

Time frame
At 90, 180, 270 and 360 days
4

Occurrence of AE of specific interest previously mentioned

The number of adverse events, expressed according to the Common Terminology Criteria for Adverse Events (CTCAE): CTCAE toxicity grading system per patient-year at days 180 and 360 for the following adverse events combined: death (all causes), grade 2 or higher leukopenia or thrombocytopenia, grade 3 or higher infections, hospitalization resulting either from the disease or from a complication due to the study treatment. \- Gammaglobulin and CD19 levels at 90, 180, 270 and 360 days

Time frame
At 90, 180, 270 and 360 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: