A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis (NCT06470048) | Clinical Trial Compass
RecruitingPhase 2
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
United States200 participantsStarted 2024-10-09
Plain-language summary
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
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* 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
* Active disease that meets at least one of the following criteria at screening:
* Disease duration of =\< 18 months defined as time from the first non-Raynaud phenomenon manifestation
* Increase in mRSS of \>= 3 units compared with the most recent assessment performed within the previous 6 months
* Involvement of one new body area and an increase in mRSS of \>= 2 units compared with the most recent assessment performed within the previous 6 months
* Involvement of two new body areas within the previous 6 months
* Elevated acute phase reactants (ESR) \>= 30 mm/hr or high-sensitivity C-reactive protein (hsCRP) \>= 6 mg/L)
* 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 following autoantibodies:
* …