A Phase 2 interventional study of Placebo and Ianalumab in Diffuse Cutaneous Systemic Sclerosis, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 96 sites in 25 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
Among 153 studies in Scleroderma, Diffuse with a site in United States — 29 open to participants now, 39 under way, 5 of them phase 3. Scleroderma, Diffuse · United States.
Among the 153 studies in Scleroderma, Diffuse with a site in United States, this one is the 12th largest by enrollment of the 120 interventional ones that give a count, is one of 11 that started in 2024, is one of 41 in phase 2, reaches primary completion later than 13 of the 38 other live ones, and was the 133rd registered.
310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.
Browse Scleroderma, Diffuse studies →29 of the 153 studies in Scleroderma, Diffuse with a site in United States are open now. Recruiting first, the newest first:
Miltenyi Biomedicine GmbH · Sites in United States
Ages 18+
Mediar Therapeutics · Sites in United States, Australia, France and 7 more countries
Ages 18+
Galderma R&D · Sites in United States, Switzerland
Ages 18+
Allogene Therapeutics · Sites in United States, Canada
Ages 18–74
Boston University · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 55 Scleroderma, Diffuse studies recruiting now, 28 (51%) set no upper age limit and 20 (36%) stop at 75 or younger; 10 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
153 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 38 · Phase 2 62 · Phase 3 18 · Phase 4 2
First in 1992; this study’s year is marked. 11 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 203 is above the median of 38 across 227 interventional studies indexed under Scleroderma, Diffuse.
Median enrollment 29 across the 120 interventional studies, 197 across the 32 observational. Of the 100 that completed or were terminated, 40 (40%) have results posted.
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61 of 153 have an industry lead sponsor. The 10 most frequent:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Novartis Pharmaceuticals has 3 studies filed under Scleroderma, Diffuse — fewer than ten, so there is no comparison to draw.
8 of the studies in Scleroderma, Diffuse with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925803Phase 3AstraZenecaDetermine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) | 2027-01-06 |
| NCT06195072Scleroderma Research Foundation, Inc.Platform Clinical Study for Conquering Scleroderma | 2026-11 |
| NCT03276923Duke UniversityMaternal Autoimmune Disease Research Alliance (MADRA) Registry | 2027-01-01 |
| NCT06152172David PorterCARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101 | 2027-02 |
| NCT06843239Zura Bio IncTibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE) | 2027-05 |
Among the 153 studies in Scleroderma, Diffuse with a site in United States, from their registry updates:
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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
The study consists of the following periods:
Key Inclusion Criteria:
Active disease that meets at least one of the following criteria at screening:
Participant must be positive for at least one of the following autoantibodies:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment Period 1: Ianalumab subcutaneous (s.c.) injection as defined in the protocol Treatment Period 2: Open-label (OL) Ianalumab subcutaneous (s.c.) injection as defined in the protocol
Drug: Ianalumab
Treatment Period 1: Placebo to Ianalumab subcutaneous (s.c.) injection as defined in the protocol Treatment Period 2: Open-label (OL) Ianalumab subcutaneous (s.c.) injection as defined in the protocol
Drug: Placebo · Drug: Ianalumab
Ianalumab matching placebo subcutaneous (s.c.) injection as defined in the protocol
subcutaneous (s.c.) injection as defined in the protocol
Also known as: VAY736
3/5 rCRISS25 response
To demonstrate the superiority of ianalumab, compared to placebo, in achieving 3/5 Revised Composite Response Index in Systemic Sclerosis 25 (rCRISS25) response at Week 52
Time frame: Week 52
Change from baseline in FVC% predicted at Week 52
To demonstrate the superiority of ianalumab, compared to placebo, on change from baseline in percent-predicted forced vital capacity (FVC%) at Week 52
Time frame: Week 52
Change from baseline in mRSS at Week 52
To demonstrate the superiority of ianalumab, compared to placebo, on change from baseline in modified Rodnan Skin Score (mRSS) at Week 52
Time frame: Week 52
Change from baseline in HAQ-DI at Week 52
To demonstrate the superiority of ianalumab, compared to placebo, on change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52
Time frame: Week 52
Ianalumab concentrations in serum during treatment and Follow-up Period
To assess the pharmacokinetics of ianalumab
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, Week 64, Week 76, Week 88, Week 104, Week 108, Week 112, Week 116, Week 120, Week 124 and Week 208
Incidence and titer of anti-drug (ianalumab) antibodies (ADAs) in serum over time
To evaluate the immunogenicity of ianalumab
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, Week 64, Week 76, Week 88, Week 104, Week 124, Week 208
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
The distribution of adverse events for ianalumab will be done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs) through the monitoring of relevant clinical and laboratory safety parameters.
Time frame: Up to Week 208
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Started Oct 2024 (actual). Primary completion is estimated for Jul 2027, 33 months after the start.
Of 24 phase 2 interventional studies under Scleroderma, Diffuse, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 108. This study's planned 33 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ianalumab