To find out if a new medicine called ianalumab is safe and works well for adults with a condition called diffuse cutaneous systemic sclerosis that involves the hardening and tightening of the skin

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 - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075411

Enrollment

200

Registered

2024-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: M349- Systemic sclerosis, unspecified

Interventions

Intervention1: Ianalumab: 300 mg Injections through veins Sub Cutaneous monthly 52 weeks Intervention2: Matching Placebo: Placebo injections through veins monthly for 52 weeks Control Intervention1: N

Eligibility

Inclusion criteria

Inclusion criteria: Adults diagnosed with dcSSc are allowed to participate in the study.

Exclusion criteria

Exclusion criteria: Participants must not have any chronic infections including hepatitis, tuberculosis, or HIV. To take part in the study, participants cannot be pregnant or breastfeeding.

Design outcomes

Primary

Measure	Time frame
Do participants that receive ianalumab have less dcSSc disease activity than those who receive placebo?Timepoint: The number of participants who can get better in 3 out of 5 dcSSc disease activity measures at Week 52 without worsening.	—

Secondary

Measure	Time frame
• Do participants who receive ianalumab show improvement in lung function, assessment of skin thickness and difficulty in performing daily activities compared to placebo at Week 52?Timepoint: By measuring the FVC%, mRSS and HAQ-DI at Week 52;Is it safe to use ianalumab as a treatment for a long time?Timepoint: every 4 week;Are any antibodies produced against ianalumab?Timepoint: every 12 week;How much ianalumab can be measured over time in the participant’s blood?Timepoint: week 4,8,12 week 36	—

Measure

Time frame

• Do participants who receive ianalumab show improvement in lung function, assessment of skin thickness and difficulty in performing daily activities compared to placebo at Week 52?Timepoint: By measuring the FVC%, mRSS and HAQ-DI at Week 52;Is it safe to use ianalumab as a treatment for a long time?Timepoint: every 4 week;Are any antibodies produced against ianalumab?Timepoint: every 12 week;How much ianalumab can be measured over time in the participant’s blood?Timepoint: week 4,8,12 week 36

—

Countries

Argentina, Australia, Belgium, Brazil, Colombia, France, Germany, Greece, Hungary, India, Italy, Mexico, Poland, Republic of Korea, South Africa, Spain, Thailand, Turkey, United Kingdom, United States of America, Viet Nam

Contacts

Public ContactMurugananthan K

Novartis Healthcare Private Limited

murugananthan.k@novartis.com912250243544

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026