A randomized, double-blind, parallel group, placebo-controlled multicenter study to evaluate efficacy, safety and tolerability of ianalumab in participants with diffuse cutaneous systemic sclerosis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511933-36-00

Acronym

CVAY736S12201

Enrollment

Registered

2024-10-21

Start date

2025-01-02

Completion date

Unknown

Last updated

2025-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse cutaneous systemic sclerosis (dcSSc)

Brief summary

3/5 rCRISS25 response at Week 52

Detailed description

Change from baseline in FVC% predicted at Week 52., Change from baseline in mRSS at Week 52., Change from baseline in HAQ-DI at Week 52., Ianalumab concentrations in serum during treatment and Follow-up Period, Incidence and titer of anti-drug (ianalumab) antibodies (ADAs) in serum over time, Safety evaluation includes adverse events, laboratory parameters, and vital signs

Interventions

DRUGTENOFOVIR ALAFENAMIDE

DRUGENTECAVIR

DRUG-

DRUGPlacebo to VAY736 150 mg/1 mL Solution for injection in pre-filled syringe

DRUGTENOFOVIR DISOPROXIL

DRUGVAY736

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
3/5 rCRISS25 response at Week 52	—

Secondary

Measure	Time frame
Change from baseline in FVC% predicted at Week 52., Change from baseline in mRSS at Week 52., Change from baseline in HAQ-DI at Week 52., Ianalumab concentrations in serum during treatment and Follow-up Period, Incidence and titer of anti-drug (ianalumab) antibodies (ADAs) in serum over time, Safety evaluation includes adverse events, laboratory parameters, and vital signs	—

Countries

Austria, Belgium, France, Germany, Greece, Hungary, Italy, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026