Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 2 Infection

Summary

This is a randomized, double-blind, double-dummy study of single dose HDIT101 versus Standard of Care Valaciclovir. HSV-2-positive patients with at least 4 anogenital herpes lesions in the last 12 months (or at least 2 herpes lesions with previous valaciclovir long-term therapy) can be included. If a patients develops a anogenital Herpes lesion within 4 months after the screening visit, the patients will be randomized in a 2:1 ratio to HDIT i.v. infusion + episodic treatment with 500 mg Valaciclovir-placebo OR to a single HDIT placebo infusion + episodic treatment with 500 mg Valaciclovir orally bid for 3 days. Study duration per patient will be 180 days starting with the randomization visit. In addition to the randomization visit, 4 visits at the site and 2 phone calls are scheduled. At every occurence of a herpetic lesion during the study, patients are treated with Valaciclovir/ Valaciclovir-placebo and need to present at the site twice to document start and end date of the lesion (unscheduled visits).

Timeline

Start

2019-11-15

Primary completion

2021-08-25

Completion

2021-11-01

Publications

• Stellbrink HJ, Schaller T, Sturm K, Brockmeyer NH, Potthoff A, Bickel M, Scholten S, Postel N, Jessen A, Muller M, Jager D, Muller C, Seyfizadeh N, Schoffel S, Ullrich B, Brosi L, Kunz C, Thomas D, Laage R, Hanakam F, Schwab M, Schonborn-Kellenberger O, Mangold M, Och K, Lehr T, Arndt MA, Krauss J. Safety and efficacy of monoclonal antibody therapy in patients with chronic herpes simplex virus-2 genital infections: MATCH-2, a randomized double-blinded, parallel-group phase 2 multi-center trial. Pharmacol Res. 2025 Nov;221:107999. doi: 10.1016/j.phrs.2025.107999. Epub 2025 Oct 16.

Drugs

Indications