A Phase 1 interventional study of IMP Application KM-001 and Chemistry in Lichen Simplex Chronicus, sponsored by Kamari Pharma Ltd. Completed at 2 sites in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Kamari Pharma Ltd · Phase 1, Interventional, and Treatment
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,
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).
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
22 studies on the registry are indexed under Neurodermatitis; 3 are open to participants now.
This study's enrollment of 55 is above the median of 44 across 22 interventional studies indexed under Neurodermatitis.
Browse Neurodermatitis studies →Kamari Pharma Ltd is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Chronic moderate to severe pruritus defined as:
Clinical diagnosis of LSC for at least 8 weeks prior to screening:
In addition to the hormonal contraception, female patients must agree to use a supplemental barrier method during intercourse with a male partner (i.e., male condom) throughout the study and for at least 4 weeks after last application of IMP.
Female patients must be having regular menstrual periods (interval of 21-35 days, duration of 2-7 days for several months) at the baseline visit (as reported by the patient); exception: patients using hormonal contraceptives that preclude regular menstrual periods, menopausal or hysterectomized patients. A male patient with a pregnant or non-pregnant female partner of childbearing potentialmust use adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice; as a minimum, the male patient must agree to use condom during treatment and until the end of relevant systemic exposure in the male subject (7 days post-treatment).
Male patients must refrain from sperm donation throughout the study and for 7 days after the last study drug administration.
Documented hysterectomy or bilateral oophorectomy at least 3 months before the study.
Exclusion Criteria:
Patients with the following medical conditions:
History of lymphoproliferative disease or history of of any organ system within the last 5 years, except for:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
KM-001 0.3% cream will be applied to the affected area twice daily for 4 consecutive weeks.
Drug: IMP Application KM-001 · Diagnostic Test: Chemistry · Diagnostic Test: Hematology · Diagnostic Test: Urinalysis · Diagnostic Test: Serelogy · Diagnostic Test: 12-Lead ECG · Diagnostic Test: Pregnancy test · Diagnostic Test: Blood PK sampling · Procedure: Physical Examination · Procedure: Vital signa · Diagnostic Test: Investigator's Global Assessment · Diagnostic Test: Itch Assessment via PP-NRSj · Other: E-diary data
KM-001 0.3% cream will be applied to the affected area twice daily for 4 consecutive weeks.
Drug: IMP Application KM-001 · Diagnostic Test: Chemistry · Diagnostic Test: Hematology · Diagnostic Test: Urinalysis · Diagnostic Test: Serelogy · Diagnostic Test: 12-Lead ECG · Diagnostic Test: Pregnancy test · Diagnostic Test: Blood PK sampling · Procedure: Physical Examination · Procedure: Vital signa · Diagnostic Test: Investigator's Global Assessment · Diagnostic Test: Itch Assessment via PP-NRSj · Other: E-diary data
Vehicle cream will be applied to the affected area twice daily for 4 consecutive weeks.
Drug: IMP Application KM-001 · Diagnostic Test: Chemistry · Diagnostic Test: Hematology · Diagnostic Test: Urinalysis · Diagnostic Test: Serelogy · Diagnostic Test: 12-Lead ECG · Diagnostic Test: Pregnancy test · Diagnostic Test: Blood PK sampling · Procedure: Physical Examination · Procedure: Vital signa · Diagnostic Test: Investigator's Global Assessment · Diagnostic Test: Itch Assessment via PP-NRSj · Other: E-diary data
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.
Also known as: Experimental drug administration
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.
Also known as: Blood test
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.
Also known as: Blood test
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.
Also known as: Urine test
Patients will provide a blood sample for serelogy test at day -14 (screening visit)
Also known as: Blood test
patients will undergo an ECG examination on days -14 (screening visit), and day 28 (end of treatment visit).
Women of child-bearing potential only will provide at all the on-site visits b-hCG concentration will be tested
Also known as: Blood test
PK test will be performed on day 1, 7, 28, 35 and on ET visit
patients will undergo a physical examination on all the clinical visits
patient's vital signs will be measured on all the clinical visits
patient's disease evaluations will be evaluated on all the clinical visits
Also known as: score
patient's disease evaluations will be evaluated on all the clinical visits
Also known as: score
The patient will record IMP adminidsration and AE events in a diary every day throughout the all study period
Safety endpoint - Will be assessed through collection and analysis of adverse events
Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Time frame: up to 7 weeks
Safety endpoint-Hematology blood test
RBC, WBC and platelets count, absolute neutrophils, lymphocytes, monocytes, eosinophil and basophil counts, reticulocyte count, hemoglobin, hematocrit, MCV and MCH will be tested and assess. The assessment will be compared thr baseline results. Exceptional values above the normal or below the normal will indicate an aggravation of the participant's condition
Time frame: up to 7 weeks
Safety endpoint- Serology blood test - HBV
HBsAb,HBsAg, HBcAb will be prformed at screening visit. laboratory measurements will be assessed and listed.
Time frame: up to 14 days
Safety endpoint- Serology blood test- Hepatits C
Hepatits C virus antibody will be prformed at screening visit. laboratory measurements will be assessed and listed.
Time frame: up to 14 days
Safety endpoint- Serology blood test- HIV
HIV will be prformed at screening visit. laboratory measurements will be assessed and listed.
Time frame: up to 14 days
Safety endpoint-Chemistry
Chemistry measurements will be presented descriptively by visit including changes from baseline for quantitative outcomes. Shift tables showing changes with respect to the normal range between baseline and each post-baseline visit will be shown. Incidence of any laboratory outcome of clinical significance will be shown for scheduled and unscheduled measures, including a presentation for each laboratory parameter.
Time frame: up to 7 weeks
Safety endpoin-Urine tests
Specific gravity, pH, glucose, protein, blood and ketones by will perform by dipstick. assessment will be compared to the normal range. Change from baseline (Day -14 to -1 \[screening/Visit 1\]) in safety laboratory parameters at Day 7 (Visit 3 or ETV) and Day 28 (Visit 4 or ETV)
Time frame: up to 7 weeks
Safety endpoin-Pregnancy test
In women of child-bearing potential only. At all the on-site visits serum beta-human chorionic gonadotropin (b-hCG) concentration will be tested.
Time frame: up to 7 weeks
Safety endpoin-Vital signs- Pulse
units: BPM (beats per minute) Data management team will assess and review the vital signs. The category of the assessments will be compared to the normal ranges. Exceptional values above the norm or below the norm indicate an aggravation of the participant's condition
Time frame: up to 7 weeks
Safety endpoin-Vital signs- Blood pressure
units: blood pressure \[mm Hg\]. Data management team will assess and review the vital signs. The category of the assessments will be compared to the normal ranges. Exceptional values above the norm or below the norm indicate an aggravation of the participant's condition
Time frame: up to 7 weeks
Safety endpoin-Vital signs- Body temperature
body temperature will be assesed and the changes from the baseline. units:Celsius degrees. Data management team will assess and review the vital signs. The category of the assessments will be compared to the normal ranges.
Time frame: up to 7 weeks
Safety endpoin-Electrocardiogram
A 12-lead, resting, digital ECG will be taken for each participant at Screening and on Day 28 or at ETV. the following ECG parameters will be recorded: heart rate (HR), PR, QT and QRS intervals and QTC. Resting ECG parameter and changes from baseline will be assesed
Time frame: up to 7 weeks
Safety endpoin-Physical examination
A complete examination will be performed at screening and baseline: As a minimum, the following body systems will be examined and listed: basic status of the main organ systems (ear nose throat, heart, lungs, abdomen, neurological status) as well as physical examination of the skin. An abbreviated examination including a comprehensive skin examination will be performed at other indicated visits. Height and weight measurement will be performed at screening only.
Time frame: up to 4 weeks
KM-001 plasma levels (PK) - Cmax
CMAX measurement (mg/ml)
Time frame: Up to 5 weeks
KM-001 plasma levels (PK) - Tmax
Tmax measurement (h)
Time frame: Up to 5 weeks
KM-001 plasma levels (PK) - AUC 0-t
AUC measurement (mg\*h/L)
Time frame: Up to 5 weeks
Efficacy endpoint will be assessed through collection and analysis of lesion Assessment-IGA
Effect of the treatment on LSC-target lesion, as assessed by location shift in IGA score Effect of the treatment will be assessed using the Investigator's Global Assessment (IGA) scale, which is a 5-point scale (from 0 ="no disease" to 4="severe disease").
Time frame: up to 7 weeks
Efficacy endpoint will be assessed through collection and analysis of lesion Assessment- (PP-NRS)
Change and percent change from baseline in the PP-NRS. The measument will perform via using the peak pruritus-numerical rating scale (PP-NRS) , an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). The PP-NRS was designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours
Time frame: up to 7 weeks
Efficacy endpoint will be assessed through collection and analysis of lesion Assessment- (PP-NRS)- responders
Percent responders in PP-NRS. The measument will perform via using the peak pruritus-numerical rating scale (PP-NRS) , an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). A responder is defined to have an improvement of at least 4 points on the 11-point PP-NRS scale
Time frame: up to 7 weeks
Plan to share: No
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Ran from May 2022 to primary completion in Apr 2023, 10 months.
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Kamari Pharma Ltd