Ignite Creation Date:
2024-05-06 @ 5:50 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05454462
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2022-06-29
Brief Title:
KM-001 Cream for Treatment of Pruritus in Adult Patients With Lichen Simplex Chronicus LSC
Sponsor:
Kamari Pharma Ltd
Organization:
Kamari Pharma Ltd
Study Overview
Official Title:
Double-blind Vehicle-controlled Phase I Study to Evaluate Safety and Efficacy of a 03 and 1 Topical Formulation of KM-001 for Management of Moderate to Severe Pruritus in Adult Patients With Lichen Simplex Chronicus LSC
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 03 KM-001 1 or vehicle cream iina a ration of 111
Patients 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
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 03 KM-001 1 or vehicle cream iina a ration of 111
Patients 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None