Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 2 Infection

NCT04165122 | Completed Phase 2 DMC

• 1 other identifier: HTX101-02G
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 8

Brief 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).

Conditions

Herpes Genitalis

Keywords

Herpes Genitalis

Outcome Measures

Primary Outcomes (1)

• Percentage of days with lesion(s) per treatment group

  Primary objective is calculated as the number of days with lesion (except the lesion episode at randomization) divided by the number of study days after IMP infusion.

  180 days

Secondary Outcomes (6)

• Time to first recurrence of lesion

  180 days

• Recurrence rate of lesions

  180 days

• Duration of recurrent lesions

  180 days

• Disease-specific symptoms

  180 days

• Herpes outbreak impact

  180 days

Study Arms (2)

HDIT101 + Valaciclovir placebo

EXPERIMENTAL

Group A: Patients treated with a single i.v. infusion of 2 g HDIT101 for 60 min at the randomization visit and with an episodic Valaciclovir placebo bid for 3 days.

Biological: HDIT101; Drug: Valaciclovir placebo

HDIT101 placebo + Valaciclovir

ACTIVE COMPARATOR

Group B: Patients treated with a single i.v. infusion of HDIT101 placebo for 60 min at the randomization visit and with episodic Valaciclovir 500 mg twice daily for 3 days.

Drug: Valaciclovir; Biological: HDIT101 placebo

Interventions

HDIT101 BIOLOGICAL

i.v. Infusion

HDIT101 + Valaciclovir placebo

Valaciclovir DRUG

oral application of encapsulated Valaciclovir tablets

Also known as: Valtrex

HDIT101 placebo + Valaciclovir

HDIT101 placebo BIOLOGICAL

i.v. Infusion

HDIT101 placebo + Valaciclovir

Valaciclovir placebo DRUG

oral application of encapsulated Valaciclovir placebo tablets

HDIT101 + Valaciclovir placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at the time of signing informed consent.
• Signed informed consent for participation in the study.
• Understanding, ability, and willingness to fully comply with study interventions and restrictions.
• Seropositive for HSV-2.
• History of chronic recurrent anogenital HSV-2 infection with ≥ 4 outbreaks (≥ 2 under standard suppressive antiviral therapy) in the last year with no active lesion at time of enrolment. Patients with acute lesion(s) can be enrolled when the previous lesion is healed off.
• No use of any HSV-suppressant therapy (both approved drugs and non-approved drugs including OTC drugs) including topical applications at least 7 days prior to enrolment.
• Willingness to not use any topical or systemic anti-HSV therapy (both approved drugs and non-approved drugs including OTC) during the study apart from the study medication.
• Willingness to not use any topical HSV treatment upon lesion development as well as avoid any manipulation or physical impact, e.g., cooling of the lesion particularly in the prodromal stage.
• Medical assessment with no clinically significant morbidities or abnormalities as per judgement of the investigator.
• Women of child-bearing potential (WCBP) must have a negative beta-human chorionic gonadotropin (β-HCG) urine and/or blood test at screening and within 72 hours before receiving study treatment.
• Willingness to use two independent effective contraceptive methods for 3 months after Visit 1. Male participants and partners of female participants have to use a condom during sexual intercourse or intimacy to reduce the probability of sexually transmitted infection.

You may not qualify if:

• Patients who do not develop a lesion during the 28-day swabbing period and 3 months (90 days) afterwards (i.e., within 4 months after screening).
• Medical history or current physical illnesses/medical conditions that constitute an unacceptable risk for study participation in the judgment of the investigator (e.g., clinically significant autoimmune disorder, active infection, uncontrolled medical conditions or organ system dysfunction that, in the investigator's opinion, could compromise the patient's safety or put the study outcomes at risk, such as uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled coronary heart disease, uncontrolled psychiatric condition).
• Patients with herpes keratitis.
• Immunomodulatory therapy including topical (e.g., rectal, vaginal, cutaneous, etc.) and/or oral and/or parenteral and/or inhaling steroids within 28 days before start of study treatment.
• Any condition that precludes the sampling of up to 200 mL (additional 150 mL in case of optional participation for exploratory objective (T-cell response)) blood over the duration of the study.
• Known resistance to or intolerance of valaciclovir or active substance or excipients of the study medication.
• Positive HIV antibody screen, hepatitis B virus (HBV) infection screen, or hepatitis C virus (HCV) antibody screen.
• Any known history of severe allergic or anaphylactic reactions.
• Participation in any clinical study within the last 30 days prior to enrolment.
• Prior participation in this or other clinical study with HDIT101.
• Pregnant or breast-feeding women.
• Prior malignant disease except basal cell carcinoma or carcinoma in situ which has been successfully cured more than 5 years before enrolment.
• Hemoglobin (Hb) \< 10 g/dL.
• Creatinine (Crea) clearance (Cl) \< 40 mL/min (Cockcroft-Gault equation will be used)
• Bilirubin \> upper limit of normal (ULN) x 2, except patients with known Morbus Meulengracht.

Sponsors & Collaborators

• Heidelberg ImmunoTherapeutics GmbH: lead

Study Sites (8)

emovis GmbH

Berlin, 10629, Germany

Location

Praxis Jessen2+Kollegen

Berlin, 10777, Germany

Location

WIR "Walk In Ruhr" im St. Elisabeth Hospital

Bochum, 44787, Germany

Location

Dr. Scholten und Schneeweiß GbR

Cologne, 50674, Germany

Location

Infektio Research GmbH & Co. KG

Frankfurt, 60596, Germany

Location

Universitätsklinikum Freiburg, Medizin II, Infektiologie

Freiburg im Breisgau, 79106, Germany

Location

ICH Grindel

Hamburg, 20146, Germany

Location

Prinzmed

München, 80336, Germany

Location

Related Publications (1)

• 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.

  PMID: 41109488 DERIVED

MeSH Terms

Conditions

Herpes Genitalis

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Stefan Schoeffel

  Heidelberg ImmunoTherapeutics GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Block randomisation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Double-Dummy

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 15, 2019
• Study Start: November 15, 2019
• Primary Completion: August 25, 2021
• Study Completion: November 1, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

DE (8)