Ucla Listing Details Phase 2 Ianalumab Study In DcSSc

Key Takeaways:

• The listing describes an actively recruiting phase 2 placebo-controlled study of subcutaneous ianalumab in diffuse cutaneous systemic sclerosis.
• Enrollment is limited by protocol-defined diagnosis, age, disease-duration, and baseline skin-score thresholds.
• Screening also depends on the listed activity, serologic, and exclusion criteria, and the page does not show additional endpoint detail.

The trial is an evaluation of efficacy, safety, and tolerability for s.c. ianalumab versus placebo. It also identifies a treatment-focused interventional design and an active recruitment status. Together, these elements outline the protocol’s stated aim and registry-level study structure.

Enrollment is limited to adults aged 18 to 70 years who meet 2013 ACR/EULAR classification criteria for systemic sclerosis. Participants must also satisfy the protocol’s diffuse cutaneous subset classification. The study lists a disease-duration limit of 60 months or less from the first non-Raynaud manifestation, and it specifies a baseline modified Rodnan skin score of 15 to 45 at screening. Overall, the listing focuses entry on a defined early-disease diffuse cutaneous systemic sclerosis population.

The protocol describes active disease at screening using at least one qualifying feature rather than a single mandatory marker. Eligibility pathways include disease duration of 18 months or less, recent worsening in skin score, one or two newly involved body areas, elevated ESR or high-sensitivity C-reactive protein, and systemic sclerosis interstitial lung disease with ATA positivity. The page also includes a modified EUSTAR disease activity index of 2.5 or higher. Serologic eligibility requires at least one listed autoantibody, including anti-topoisomerase I, anti-RNA polymerase III, or ANA at 1:80 or higher. ANA positivity alone is capped at 30% of the randomized population, further narrowing screening to protocol-defined activity and serologic features beyond the diagnosis criteria.

The ianalumab study excludes rheumatic disease outside diffuse cutaneous systemic sclerosis, ACA positivity without ATA or anti-RNAP3, and prior skin-score improvement greater than 10 units. It also lists pulmonary limits, including forced vital capacity at or below 50% predicted, DLCO at or below 40% predicted, and more advanced pulmonary arterial hypertension. Disallowed treatment exposures include cyclophosphamide within 12 weeks, biologics within 12 weeks or five half-lives, investigational agents within four weeks or five half-lives, and recent anti-fibrotic therapy. Women of childbearing potential must use highly effective contraception during study treatment and for six months after stopping treatment. Collectively, these criteria set boundaries around prior treatment exposure and other screening exclusions.