NCT05454462

KM-001 Cream for Treatment of Pruritus in Adult Patients With Lichen Simplex Chronicus (LSC)

Double-blind, Vehicle-controlled, Phase I Study to Evaluate Safety and Efficacy of a 0.3% and 1% Topical Formulation of KM-001 for Management of Moderate to Severe Pruritus in Adult Patients With Lichen Simplex Chronicus (LSC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Kamari Pharma Ltd · Network
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, multi-center, randomized, vehicle-controlled, double-blinded, parallel-group study. Approximately 6 sites will conduct the study at Germany. Approximately 61 patients (male and female) planned to be screened. 51 patient planned to be randomized. Patients will be randomized to 1 of 3 treatment arms (KM-001 0.3%, KM-001 1%, or vehicle cream) iina a ration of 1:1:1 Patient's duration of participation will be up to 7 weeks, * a screening period with 1 visit (Visit 1) within up to 14 days (Days -14 to -1), * a 4-week treatment period with 3 visits (Visit 2 on Day 0, Visit 3 on Day 7, Visit 4 at Day 28 and 2 phone calls on Days 14 and 21, and * a 1-week follow-up period with 1 visit (Visit 5 on Day 35), as well as unscheduled visits as needed Since KM-001 is tested in humans for the first time, the safety of KM-001 will be evaluated in a subgroup of 6 patients (sentinel group) at selected sites prior to screening of the remaining sites. Efficacy assessments will include subjective assessments of itch and investigator assessment of the treatment effect on LSC target lesion using scoring systems. Safety parameter (including physical examination, vital signs, ECG, standard laboratory test, and PK analysis) will be monitored from the signing of the informed consent form (ICF) until the last follow-up visit. Recording of AEs and serious AEs (SAEs) will be done throughout the study with special attention to local AEs in the treatment area (LSC target lesion, dermal safety).

Detailed description

This phase I study will be performed in patients with LSC instead of healthy subjects as in these patients, the significant histological changes (acanthosis and parakeratosis) result in heavily altered physiology and anatomy of the skin and any data including tolerability generated by administering the IMP on healthy skin can hardly be extrapolated to patients with LSC. The setting can be compared with early studies in Psoriasis patients where it is established to include patients from the beginning. Based on preclinical experiments, no pharmacological relevant systemic absorption is expected. PK sampling will be done for confirmation. Parallel group comparison is a common method and provides optimal conditions for examining efficacy. Comparisons to a vehicle is a common procedure. Randomization provides the most reliable and impartial method of determining differences between treatments as in this case active versus vehicle. Double-blind conditions minimize any possible observer bias regarding treatment effects. A vehicle control is included to evaluate the efficacy, safety, and tolerability of the cream without the active ingredient and to differentiate whether the drug substance or the drug product might cause any effects. A duration of a 4-week treatment period is assumed to be appropriate to assess efficacy, safety, and tolerability based on preclinical data

Conditions

• Lichen Simplex Chronicus

Interventions

Type	Name	Description
DRUG	IMP Application KM-001	KM-001 will be supplied in glass jars (30 ml) and will be provided to patients with spatulas and polyethylene gloves on all the clinical visits. the patient will use IMP twice a day for 28 days.
DIAGNOSTIC_TEST	Chemistry	patients will provide a blood sample for a chemistry blood test on days -14 (screening visit), Day 7(visit 3), day 28 (end of treatment) or at ET visit.
DIAGNOSTIC_TEST	Hematology	patients will provide a blood sample for a hematology blood test on days -14 (screening visit), Day 7(visit 3), day 28 (end of treatment) or at ET visit.
DIAGNOSTIC_TEST	Urinalysis	Patients will provide a blood sample for a urine test on days -14 (screening visit), Day 7(visit 3), day 28 (end of treatment) or at ET visit.
DIAGNOSTIC_TEST	Serelogy	Patients will provide a blood sample for serelogy test at day -14 (screening visit)
DIAGNOSTIC_TEST	12-Lead ECG	patients will undergo an ECG examination on days -14 (screening visit), and day 28 (end of treatment visit).
DIAGNOSTIC_TEST	Pregnancy test	Women of child-bearing potential only will provide at all the on-site visits b-hCG concentration will be tested
DIAGNOSTIC_TEST	Blood PK sampling	PK test will be performed on day 1, 7, 28, 35 and on ET visit
PROCEDURE	Physical Examination	patients will undergo a physical examination on all the clinical visits
PROCEDURE	Vital signa	patient's vital signs will be measured on all the clinical visits
DIAGNOSTIC_TEST	Investigator's Global Assessment	patient's disease evaluations will be evaluated on all the clinical visits
DIAGNOSTIC_TEST	Itch Assessment via PP-NRSj	patient's disease evaluations will be evaluated on all the clinical visits
OTHER	E-diary data	The patient will record IMP adminidsration and AE events in a diary every day throughout the all study period

Timeline

• Start date: 2022-05-24
• Primary completion: 2023-04-04
• Completion: 2023-04-04
• First posted: 2022-07-12
• Last updated: 2024-04-02

Locations

2 sites across 1 country: Germany