(S)-2-(2',5'-DIFLUORO-[1,1'-BIPHENYL]-4-YL)-N-METHYL-N-(4-METHYL-5-(S-METHYLSULFONIMIDOYL)THIAZOL-2-YL)ACETAMIDE for Genital herpes (HSV-2) | Genital herpes simplex

Inclusion criteria

• {"criterion_text":"- 1.\tAge 18-65 years inclusive at the time of consent.\n- 2.\tMen or women who agree to comply with any applicable contraceptive requirements of the protocol.\n- 3.\tPrior history of genital HSV-2, acquired at least 12 months prior to screening according to patient’s report. The laboratory confirmation of HSV-2 infection by positive PCR, or cell culture test, or antibody test. There is no timing requirement for the laboratory confirmation, i.e. it can be performed also at screening.\n- 4.\tFor patients currently on suppressive therapy, medical history of 3-9 recurrences within the 12 months prior to initiation of suppressive therapy as reported by the patient during screening interview. Suppressive therapy must be discontinued upon screening and at least 14 days prior to the study medication administration.\n- 5.\tFor patients not on suppressive therapy, medical history of 3-9 episodes (with genital lesion) within the last 12 months before screening as reported by the patient during screening interview.\n- 6.\tIf applicable, willingness to discontinue systemic or topical antiviral treatment at screening at least 14 days prior study medication administration.\n- 7.\tAn understanding, ability, and willingness to fully comply with study interventions and restrictions.\n- 8.\tAbility to provide written, personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related interventions."}

Exclusion criteria

• {"criterion_text":"- 1.\tGenital herpes episode presence on Day 1 (applies only at randomization).\n- 10.\tClinically relevant abnormality in the ECG, defined as one or more of the following or other finding based on a medical evaluation of the recording: a)\tProlonged QTcF > 450 ms in males and > 470 ms in females; b)\tFamily history of long QT syndrome; c)\tPR (PQ) interval shortening < 120 ms (PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre-excitation); d)\tPR (PQ) interval prolongation (> 240 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third-degree AV block, or AV dissociation; e)\te)\tPersistent or intermittent complete BBB, IBBB, or IVCD with QRS > 110 ms. Patients with QRS > 110 ms but < 115 ms are acceptable if there is no evidence of e.g., ventricular hypertrophy or pre-excitation.\n- 11.\tClinically relevant abnormality in vital signs, defined as one or more of the following or other relevant medical evaluation of the measurements: a)\tSystolic BP < 90 mmHg or > 150 mmHg; b)\tDiastolic BP < 50 mmHg or > 100 mmHg; c)\tBody temperature of > 37.7°C (on admission day). Note: Vital signs are measured after 5 minutes rest. Abnormal values may be repeated once at the discretion of Investigator.\n- 12.\tHistory of severe allergic or anaphylactic reactions to medications or vaccines.\n- 13.\tKnown allergy / hypersensitivity to additives used in the study drug.\n- 14.\tUse of another study medication within 30 days prior to receiving the first dose of study medication or enrolment in another drug or vaccine clinical trial.\n- 15. A positive antibody screen for human immunodeficiency virus (HIV), or hepatitis C virus (HCV), or a positive hepatitis B virus surface antigen (HBsAg) test.\n- 16.\tHistory of vaccination within 14 days prior to dosing.\n- 17.\tPregnancy or lactation.\n- 18.\tPrior participation in this trial (randomization).\n- 19.\tPhase 1b part: A positive result in testing for illegal drugs at screening.\n- 2.\tMedical 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, cancer, 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).\n- 20.\tPrior to randomization: 20.\tAny relevant intercurrent illness since screening.\n- 3.\tReceipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).\n- 4.\tHistory of any form of ocular HSV infection or HSV- related erythema multiforme.\n- 5.\tHistory of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the patient's ability to comply with the requirements of the study.\n- 6.\tAny abnormal laboratory value (hematology, biochemistry, serology, urine analysis) of Grade 2 or higher, which is considered as clinically significant by Investigator at screening.\n- 7.\tValue for ALT and/or AST: ≥ 3 times the upper limit of normal at screening.\n- 8.\tValue for total bilirubin > upper limit of normal (ULN) x 1.2 at screening, where in case of suspected Gilbert´s disease: total bilirubin ≤ ULN x 3 is acceptable.\n- 9.\tValue of creatinine clearance: < 60 ml/min (Cockcroft-Gault equation) at screening."}

Primary endpoints

• {"endpoint_text":"- •\tRate of HSV shedding, defined as number of days on which genital swab HSV PCR test was positive divided by the total number of days on which genital swabs were obtained in patients receiving different doses of IM-250 or placebo.","definition_or_measurement_approach":"Defined as number of days on which genital swab HSV PCR test was positive divided by the total number of days on which genital swabs were obtained in patients receiving different doses of IM-250 or placebo."}

Secondary endpoints

• {"endpoint_text":"- •\tRate of genital lesions, defined as number of days with genital lesions in all patients of a group during 28 days after the first administration of IM-250 or placebo divided by 28.","definition_or_measurement_approach":"Defined as number of days with genital lesions in all patients of a group during 28 days after the first administration of IM-250 or placebo divided by 28."}
• {"endpoint_text":"- •\tRate of genital lesions, defined as number of days with genital lesions in all patients of a group during 56 days after the first administration of IM-250 or placebo divided by 56.","definition_or_measurement_approach":"Defined as number of days with genital lesions in all patients of a group during 56 days after the first administration of IM-250 or placebo divided by 56."}
• {"endpoint_text":"- •\tHSV quantity, defined as comparison of mean log10 HSV DNA copies in patients receiving different doses of IM-250 or placebo on days that shedding is detected.","definition_or_measurement_approach":"Comparison of mean log10 HSV DNA copies in patients receiving different doses of IM-250 or placebo on days that shedding is detected."}
• {"endpoint_text":"- •\tThe rate of subclinical shedding, defined as number of days on which genital swab HSV PCR test was positive in absence of a genital lesion divided by the total number of days without lesions on which genital swabs were obtained in patients receiving different doses of IM-250 or placebo.","definition_or_measurement_approach":"Defined as number of days on which genital swab HSV PCR test was positive in absence of a genital lesion divided by the total number of days without lesions on which genital swabs were obtained."}
• {"endpoint_text":"- Determining the exposure by different doses of IM-250 as defined by: •\tthe area under the curve from 0 to infinity (AUC0-ꚙ), •\tmaximum concentration (Cmax), •\tplasma concentration at 24 hours (C24h) and 8 d (C8d), •\tthe area under the curve from 0 to 24 hours (AUC0-24), •\ttime to reach Cmax (Tmax), •\thalf-life (t1/2), •\tapparent clearance (Cl / F), •\tmean residence time (MRT), •\tvolume of distribution (Vd), •\tthe time above the specified lower target concentration (T>Ctarget).","definition_or_measurement_approach":"PK measurements including AUC0-∞, Cmax, C24h, C8d, AUC0-24, Tmax, t1/2, Cl/F, MRT, Vd, and time above specified lower target concentration (T>Ctarget)."}

Methods

• Advertisement poster - documents present: K2_Recruitment material_Advertisement Poster_ENG and K2_Recruitment material_Advertisement Poster_BUL (recruitment channel: poster; languages: English and Bulgarian).
• Digital pop-up text - documents present: K2_Recruitment material_ PopUp_Text _BUL and K2_Recruitment material_PopUp_Text_ENG (recruitment channel: digital pop-up; languages: English and Bulgarian).
• Recruitment arrangements document - K1_Recruitment arrangements (document describing recruitment arrangements; language and country-specific versions available).

Bulgaria

Earliest CTIS Part Ii Submission Date

29-11-2024

Latest Decision Or Authorization Date

24-07-2025

Processing Time Days

237

Number Of Sites

1

Number Of Participants

192

Primary sponsor

Full Name

Innovative Molecules GmbH

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

Metronomia Clinical Research GmbH

Responsibilities

sponsorDuties codes: 10, 3, 6, 7

Third parties

• {"country":"Bulgaria","full_name":"Medical Diagnostic Laboratory Bodimed 99 OOD","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Germany","full_name":"Metronomia Clinical Research GmbH","duties_or_roles":"sponsorDuties codes: 10, 3, 6, 7","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"German Capital Pharma GmbH","duties_or_roles":"sponsorDuties code: 15 (value: IMP storage)","organisation_type":"Pharmaceutical company"}
• {"country":"Bulgaria","full_name":"Convex 1991 Ltd.","duties_or_roles":"sponsorDuties codes: 1, 12, 2, 5","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Stragen Services S.A.S.","duties_or_roles":"sponsorDuties codes: 15 (value: Pharmacovigilance), 8","organisation_type":"Pharmaceutical company"}