Health Trials

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

ConditionDiffuse Cutaneous Systemic Sclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNovartis Pharmaceuticals

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female participants >= 18 and =< 70 years (at the time of the screening visit).

Diagnosis of systemic sclerosis, as defined by the 2013 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) classification criteria for SSc (van den Hoogen et al 2013) and meet the dcSSc subset classification according to LeRoy (LeRoy 1988)

Disease duration of =< 60 months (defined as time from the first non-Raynaud phenomenon manifestation, e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea)

mRSS units of >= 15 and =< 45 at the time of the screening visit

Disqualifiers

Rheumatic disease other than dcSSc, including limited cutaneous disease (lcSSc) or sine scleroderma at the screening visit. Secondary Sjogren's disease and scleroderma myopathy are not exclusionary.

Positive anti-centromere antibody (ACA+) without positive ATA or anti-RNAP3 autoantibody result at the screening visit

Previous improvement (decrease) in mRSS > 10 units

Pulmonary disease with FVC ≤ 50% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO, corrected for hemoglobin) ≤ 40% of predicted at the screening visit

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Drug

    Ianalumab matching placebo subcutaneous (s.c.) injection as defined in the protocol

  • Ianalumab

    Drug

    subcutaneous (s.c.) injection as defined in the protocol

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: VAY736 (Ianalumab)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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