New Therapeutic Target for Toxic Epidermal Necrolysis (TEN) Using Anti-CD38+ Monoclonal Antibodies.

Launched by HOSPICES CIVILS DE LYON · Jul 30, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for Toxic Epidermal Necrolysis (TEN), a rare but serious skin condition where large areas of skin peel off, often caused by a reaction to medication. TEN can be life-threatening and may cause long-term problems, especially with the eyes. Right now, there is no effective treatment. This study is testing whether a drug called DARATUMUMAB, which is already used for certain cancers, can help by targeting and removing the harmful immune cells that cause the skin damage. The hope is that giving this drug soon after hospital admission will slow down the disease, reduce skin damage, and improve outcomes.

Adults over 18 years old who have been diagnosed with TEN caused by a drug and whose symptoms have started within the past week may be eligible to join. Participants need to be able to understand the trial and agree to take part. Women who can become pregnant will need to have a negative pregnancy test and agree to use birth control during and for three months after treatment. People with certain other health issues, like severe lung disease or infections, or who are pregnant or breastfeeding, cannot join. If accepted, participants will receive a single infusion (a medicine given through a vein) of DARATUMUMAB shortly after hospital admission and will be carefully monitored. This study is currently not yet recruiting patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult, over 18 years old, with drug-induced SJS/NET, proven or very strongly suspected (indirect argument of certainty) and confirmed by the evaluator.
• • SJS or NET or overlap syndrome evolving for less than 7 days prior to inclusion and with a progression of the detachment or rash observed within 48 hours prior to DARATUMUMAB treatment.
• • Negative hepatitis B screening (HBs, anti HBs and HBc).
• • The patient (or a trusted support person, family member, or close relative in case of emergency) must be capable of understanding the objectives of the trial and must have given free, informed, and express consent.
• • Patient affiliated to the Social Security system or benefiting from a similar system.
• • Negative beta HCG pregnancy test for women of childbearing potential and agreement to use effective contraception during the study and up to 3 months after stopping DARATUMUMAB treatment.
• Exclusion Criteria:
• • Patient with Lyell syndrome induced by immunotherapy.
• • Known hypersensitivity to the active substance (DARZALEX) or to one of the excipients (L-histidine, L-histidine hydrochloride monohydrate, L-methionine, Polysorbate 20 Sorbitol -E420).
• • Patient with known hereditary fructose intolerance (HFI).
• • Patient with known history of chronic obstructive pulmonary disease (COPD).
• • Patient admitted with septic shock.
• • PMNs \< 1,500 /mm3 on CBC at inclusion visit.
• • Pregnant or breast-feeding women.
• • Patient under protective measures (safeguard, curatorship, guardianship) or deprived of liberty.