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A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis

StatusRecruiting
PhasePhase 2
Started2024-10-09
View on ClinicalTrials.gov ↗

Amendment history

2026-09-07
Study Status, Contacts/Locations v16
Study sitesdetails revised at 8 of 128 sites
2026-08-18
Study Status, Contacts/Locations v15
Study sitesdetails revised at 19 of 128 sites
2026-07-09
Study Status, Contacts/Locations v14
Study sitesdetails revised at 42 of 128 sites
2026-06-04
Study Status, Contacts/Locations v13
Completion pushed: 2030-07-15 → 2034-07-31
Primary completion date2027-07-06→2027-07-30
Study sites127→128
2026-03-10
Study Status, Contacts/Locations v12
Study sites120→127
Show 11 earlier versions
2025-12-19
Study Status, Contacts/Locations v11
Primary completion date2028-07-10→2027-07-06
Study sites116→120
2025-11-28
Study Status, Contacts/Locations v10
Study sites109→116
2025-10-29
Study Status, Contacts/Locations v9
Study sites103→109
2025-09-29
Study Status, Contacts/Locations v8
Study sites96→103
2025-07-28
Study Status, Contacts/Locations v7
Study sites83→96
2025-07-03
Study Status, Eligibility, Contacts/Locations v6
Study sites37→83
Eligibility criteria+459 characters
[...] m/hr or high-sensitivity C-reactive protein (hsCRP) >= 6 mg/dLL) Presence of SSc-interstitial lung disease (ILD) and ATA autoantibody positivity Modified EUSTAR disease activity index (mDAI) >≥ 2.5 Participant must be positive for at least one of the fo [...] to receipt of B cell-depleting therapy (whichever is lower). Treatment with biologic agents, such as intravenous immunog [...] eline visit, unless explicitly allowed in inclusion criteria. Treatment with any investigational agent within ≤ 4 weeks ( [...] stigational drug, whichever is longer) of the baseline visit. Use of anti-fibrotic agents including colch [...] [...]
2025-01-24
Study Status, Contacts/Locations v5
Study sites26→37
2024-12-20
Study Status, Contacts/Locations v4
Study sites10→26
2024-11-18
Study Status v3
Re-verified, no change to tracked fields
2024-10-10
Study Status, Contacts/Locations v2
Start dateestimated 2024-07-31→confirmed 2024-10-09
Study sites1→10
2024-08-05
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2024-06-17
Original filing
Novartis
552 trials monitored
See 32 trials at risk
Scleroderma
302 trials monitored
See 9 trials at risk
The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo
Trial Details
NCT Number NCT06470048
Lead Sponsor Novartis Pharmaceuticals
Conditions Diffuse Cutaneous Systemic Sclerosis
Enrollment 200 participants
Start Date 2024-10-09
Primary Completion 2027-07-30 (estimated)
Study Completion 2034-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-28