NCT06028230: ZEN

A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Terminated Phase 2 Last updated 11 December 2025

What this trial tests

Phase 2 trial testing SAR444656 (KT-474) in Hidradenitis Suppurativa in 70 participants. Terminated before completion.

Timeline

29 September 2023

Primary endpoint
9 October 2025

12 November 2025

Quick facts

Lead sponsor	Sanofi
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	70
Start date	29 September 2023
Primary completion	9 October 2025
Estimated completion	12 November 2025
Sites	52 locations across Greece, Chile, Germany, Poland, South Korea, Canada, United States, Spain

Drugs / interventions tested

• SAR444656 (KT-474) — full drug profile →
• Placebo

Conditions studied

• Hidradenitis Suppurativa — all drugs for Hidradenitis Suppurativa →

Sponsor

Sanofi — full company profile →

Who can join

Adults 18 to 70, any sex, with Hidradenitis Suppurativa. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a parallel, Phase 2, 3-arm study to evaluate the efficacy, safety, PK, and biological effects of SAR444656 compared with placebo in adult participants with moderate to severe HS aged ≥18 to 70 years.

Study details include:

* Screening period: up to 4 weeks (30 days)
* Treatment duration: up to 16 weeks
* Follow-up period: up to 4 weeks
* Total study duration: up to 24 weeks
* Number of visits: 14

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Discovery of KT-474─a Potent, Selective, and Orally Bioavailable IRAK4 Degrader for the Treatment of Autoimmune Diseases.
   Zheng X, Ji N, Campbell V, Slavin A, et al · · 2024 · cited 44× · PMID 39151120 · DOI 10.1021/acs.jmedchem.4c01305
2. NDA Submission of Vepdegestrant (ARV-471) to U.S. FDA: The Beginning of a New Era of PROTAC Degraders.
   Ma Z, Zhou J. · · 2025 · cited 28× · PMID 40702893 · DOI 10.1021/acs.jmedchem.5c01818
3. Discovery of IRAK4 Inhibitors <b>BAY1834845</b> (Zabedosertib) and <b>BAY1830839</b>.
   Bothe U, Günther J, Nubbemeyer R, Siebeneicher H, et al · · 2024 · cited 20× · PMID 38228402 · DOI 10.1021/acs.jmedchem.3c01714
4. Breaking Bad Proteins-Discovery Approaches and the Road to Clinic for Degraders.
   Bouvier C, Lawrence R, Cavallo F, Xolalpa W, et al · · 2024 · cited 14× · PMID 38607017 · DOI 10.3390/cells13070578
5. Therapeutic Potential of IL-1 Antagonism in Hidradenitis Suppurativa.
   Calabrese L, Malvaso D, Coscarella G, Antonelli F, et al · · 2024 · cited 13× · PMID 38397412 · DOI 10.3390/biom14020175
6. Targeting TLR Signaling Cascades in Systemic Lupus Erythematosus and Rheumatoid Arthritis: An Update.
   Kalliolias GD, Basdra EK, Papavassiliou AG. · · 2024 · cited 13× · PMID 38255243 · DOI 10.3390/biomedicines12010138
7. Emerging interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitors or degraders as therapeutic agents for autoimmune diseases and cancer.
   Feng Y, Chen C, Shao A, Wu L, et al · · 2024 · cited 11× · PMID 39807338 · DOI 10.1016/j.apsb.2024.09.008
8. Proteolysis-Targeting Chimera (PROTAC): Current Applications and Future Directions.
   Fan G, Chen S, Zhang Q, Yu N, et al · · 2025 · cited 6× · PMID 41049269 · DOI 10.1002/mco2.70401