Anti-CD38 immunotherapy for severe hidradenitis suppurativa
Official title: Anti-CD38 isatuximab Immunotherapy in Hidradenitis Suppurativa: a randomized, double-blinded, placebo-controlled, seamless phase 2a/2b trial
Funded at Henry Ford Health + Michigan State University Health Sciences · NIH-11526578 · Data updated 2026-11-12
A new treatment using anti-CD38 therapy is being tested for people with severe hidradenitis suppurativa who have not responded to prior therapies.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Henry Ford Health + Michigan State University Health Sciences NIH-funded |
| Lab location | 1 site (East Lansing, United States) |
| Project start | August 1, 2025 |
| Project end | August 31, 2031 |
| Funding year | 2026 |
| Award (this year) | $2,071,075 |
| NIH project number | 4UH3AR085895-02 |
| Project ID | NIH-11526578 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with severe hidradenitis suppurativa (Hurley stage III) who have failed adalimumab and have high CD38 expression in blood or skin.
✕Less likely to help
Patients without high CD38 expression or not meeting stage III criteria may not benefit from the therapy being tested.
What this research studies
This trial tests whether the anti-CD38 drug isatuximab can help people with severe hidradenitis suppurativa (Hurley stage III) who have high CD38 levels. It is a randomized, double-blind, placebo-controlled study designed to measure safety and how well the treatment works. Participants will either receive isatuximab or a placebo in a seamless phase 2a/2b format, with careful monitoring for inflammatory markers and adverse effects. The study builds on ex-vivo findings and focuses on patients with CD38-bearing immune cells, aiming to provide a new option for HS patients who have exhausted other treatments.
Why it matters
Potential benefit: If successful, patients could gain improved skin symptoms and reduced inflammation from a targeted immune therapy.
How similar studies have gone: Preliminary ex-vivo results and prior uses of anti-CD38 in other diseases suggest potential benefit, but direct HS clinical data are emerging.
Where this research is happening
-
Henry Ford Health + Michigan State University Health Sciences
East Lansing, United States Active
Researchers
- Principal investigator: Mi, Qing-Sheng — Henry Ford Health + Michigan State University Health Sciences
- Study coordinator: Mi, Qing-Sheng
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.