Trial to test scleroderma treatments at earliest stages of disease

A clinical trial will study investigational therapies in people at the earliest stages of systemic sclerosis (SSc), before irreversible organ damage has occurred.

Contract research organization Indero and the World Scleroderma Foundation (WSF) are partnering on the trial, called WSF SHIELD. It will test multiple investigational therapies in people with SSc who meet the Very Early Diagnosis of Systemic Sclerosis (VEDOSS) criteria, which identify those in the very early stages of the disease.

“Very early intervention in systemic sclerosis is the best chance we have for a future without the pain and disability that scleroderma brings to our patients,” Francesco Del Galdo, MD, a professor at the University of Leeds and co-leader of WSF SHIELD, said in a press release from Indero. “By intervening in the very early stages with the right drugs, we can transform the field and make scleroderma as we know it today, a memory from the past. The knowledge on the early biology and the infrastructure are now there, this is the right time.”

In SSc, also called scleroderma, the immune system mistakenly attacks the body’s own tissues, causing fibrosis (scarring), hardening of the skin and internal organs, and damage to blood vessels. It can affect the lungs, heart, kidneys, and digestive tract.

Indero said the new collaboration is an opportunity for pharmaceutical and biotech companies to participate in a research platform that aims to be both scientifically sound and operationally efficient. Early-stage trials in VEDOSS patients can offer advantages such as lower patient variability, a higher proportion of patients likely to respond to treatment, and reduced screening failure rates, or the number of patients screened who are ultimately deemed ineligible to participate.

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Early intervention

Dinesh Khanna, MD, a professor at the University of Michigan and the trial’s other co-lead, said the alliance offers pharmaceutical partners “access to a highly engaged ecosystem that actively supports industry-academia collaboration, encourages early-phase innovation, and increases visibility within the broader field of autoimmune research.”

The trial protocol brings together several types of measurements, including capillaroscopy, a microscopic examination of small blood vessels, particularly in the nailfold, which shows characteristic changes in scleroderma. Other assessments include lung and imaging readouts and biomarkers measured repeatedly over time to track disease progression.

“WSF SHIELD is purpose-built to enable early intervention in VEDOSS,” said Juan Ovalles, MD, PhD, senior director of rheumatology at Indero. “By harmonizing capillaroscopy, pulmonary and imaging readouts, and longitudinal biomarkers, we aim to generate decision-grade evidence while keeping patient needs at the center.”

WSF representatives on the steering committee are foundation chair Marco Matucci, MD, PhD, a professor at the University Vita Salute San Raffaele in Italy, and Yannick Allanore, MD, PhD, a professor at Paris-City University in France.

Matucci said the collaboration “represents a critical step forward in our mission to improve the lives of people living with systemic sclerosis.” Allanore added that combining the WSF’s scientific leadership with Indero’s operational capabilities is “creating new opportunities for early intervention, patient-centered research, and industry engagement that can truly change the trajectory of this disease.”