Hoth Therapeutics reported interim Phase IIa results for HT-001 in cancer patients experiencing EGFR inhibitor-associated dermatologic toxicities, according to a May 5, 2026 press release, which also announced regulatory authorization in Spain to expand the ongoing CLEER trial. The New York-based company said patients achieved the primary efficacy endpoint, with rash severity reduced to clinically manageable levels, defined as an ARIGA score of 1 or below, by Week 6.
The CLEER trial is a randomized, placebo-controlled, parallel, dose-ranging Phase IIa study evaluating HT-001 in patients with EGFR inhibitor-related dermatologic toxicities. According to interim data reported by the company, more than 65% of patients reported reductions in pain and itching, and no patients required dose reduction or discontinuation of their underlying EGFR inhibitor cancer therapy. Hoth also stated that no treatment-limiting adverse events were observed. The number of patients included in this interim analysis was not disclosed, nor were dosing details or Data Safety Monitoring Board oversight information.
The trial, registered under CTIS2025-523058-16-00, is enrolling patients across the United States, Hungary, and Spain, with the Spanish authorization announced concurrently with the interim readout. The data are interim and drawn from an unspecified subset of enrolled patients; full enrollment figures and unblinded comparative data between active and placebo arms were not reported. The interim nature of the dataset and the absence of patient-level or statistical detail limit interpretation of the findings at this stage.