Lichen Simplex ChronicusPhase 1NCT05454462
KM-001 Cream for Treatment of Pruritus in Adult Patients With Lichen Simplex Chronicus (LSC)
A Phase 1 study testing IMP Application KM-001, Chemistry and Hematology in people with Lichen Simplex Chronicus, run by Orvida Pharma (formerly Kamari Pharma) at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lichen Simplex Chronicus
- What is being tested?
- IMP Application KM-001, Chemistry and Hematology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 2 sitesGermany
- Study dates
- 24 May 2022to 4 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Read, understood, and signed an ICF before any investigational procedure(s) are performed.
- Male or female and aged ≥18 to 75 years at the time of screening.
- Chronic moderate to severe pruritus defined as:
- Itching that has been present for 6 weeks or more prior to the screening AND
- At the screening visit (Visit 1) and enrollment visit (Visit 2): peak pruritus-numerical rating scale (PP-NRS)24h is ≥7.
- Clinical diagnosis of LSC for at least 8 weeks prior to screening:
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- LSC lesions defined as dry, scaly, thickened plaques of skin (lichenification) caused by repeated rubbing or scratching, on upper limbs, trunk, and/or lower limbs.
- To have no more than 3 lesions, total size not exceeding 5% of BSA from which one (target lesion) will be selected for treatment (minimum area of lesion selected for treatment: 0.5% BSA).
- Female patients of childbearing potential1 must use a highly effective birth control method(failure rate ˂1% per year when used consistently and correctly) (17) throughout the study and for at least 4 weeks after last application of IMP.
- 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.
- 7. Female patients of non-childbearing potential must meet one of the following criteria:
- Absence of menstrual bleeding for 1 year prior to screening without any other medical reason.
- Documented hysterectomy or bilateral oophorectomy at least 3 months before the study.
- 8. Patient is willing and able to comply with all of the time commitments and procedural requirements of this CTP, including daily e-diary recordings by the patient using an electronic handheld device and an internet connection during the study.
Who cannot join
- Known hypersensitivity or any suspected cross-allergy to the active pharmaceutical ingredient (API) and/or excipients.
- Chronic pruritus resulting from another active condition other than LSC such as, but not limited to, psoriasis, atopic dermatitis, lichen planus contact dermatitis, folliculitis, habitual picking, bullous autoimmune disease, neuropathy.
- Genital, anal or scalp LSC.
- History of or current confounding skin condition (psoriasis, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], chronic actinic dermatitis with [present or previous] skin cancer on the site of LSC, bullous disorders, dermatitis herpetiformis).
- Cutaneous infection within 1 week before the screening visit or any infection requiring treatment with oral, parenteral antibiotics, antivirals, antiparasitics or antifungals or any topical within 1 week before the screening visit. Patients may be rescreened once the infection has resolved.
- Positive hepatitis B surface antigen [HBsAg], hepatitis B core antibody [HBcAb], hepatitis C antibody, or human immunodeficiency virus antibody serology results at the screening visit.
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- Patients with active atopic dermatitis.
- Neuropathic and psychogenic pruritus, such as, but not limited to, notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis.
- Patients with the following medical conditions:
- High blood pressure (BP), defined as resting systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg (according to 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice [18]).
- Patients with poorly controlled and/or complicated (retinopathy/nephropathy/neuropathy) diabetes glycosylated hemoglobin (HbA1c) of >7%, fasting serum glucose >130 mg/dl.
- Patients with history of angina pectoris and/or myocardial infarction.
- Systemic autoimmune conditions (including, but NOT limited to: systemic lupus erythematosus, rheumatoid arthritis etc.).
- Small fiber neuropathy.
- Any other condition that could, in the investigator's opinion, affect patient safety, his ability to participate in the study or ability of the investigator to assess the skin.
- Having received any of the prohiboted treatments in Table 1 within the specified timeframe before the baseline visit.
- Pregnant women (positive serum pregnancy test result at the screening and baseline visits), breastfeeding women, or women planning a pregnancy during the clinical trial.
- History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for:
- Basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that had been treated and with no evidence of recurrence in the last 52 weeks before the baseline visit, or;
- Actinic keratoses that had been treated and with no evidence of recurrence in the last 8 weeks.
- Any known or suspected state of immunodeficiency due to primary or secondary immunodeficiency syndromes, organ transplants (except corneal transplant), previous opportunistic infection, or any other state of immunodeficiency as judged by the investigator.
- Any clinically relevant disorder or abnormal finding which could affect the safety of the patient throughout the study and/or impede the patient's ability to complete the study, as assessed by the investigator.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or bilirubin exceeding the upper limit of normal (ULN), or any other laboratory abnormalities considered clinically relevant by the investigator, at the screening/baseline visit.
- Any condition that may put the patient at significant risk according to the investigator's judgment.
- Any disorder which may interfere with study assessments (e.g., poor venous access or needle-phobia).
- Major surgical procedure planned or expected during the clinical trial.
- Patient is unwilling to refrain from using prohibited medications during the clinical trial.
- Currently participating or participated in any other study of a drug or device, within the past 2 months before the screening visit, or is in an exclusion period (if verifiable) from a previous study.
- Close affiliation with the investigator (e.g., a close relative) or persons working at bioskin GmbH or the study sites or patient is an employee of sponsor.
- Patient is institutionalized because of legal or regulatory order.
- Patients who have been administered any vaccine for COVID-19 within 30 days prior to first treatment.
- Tattoos and scars in the areas to be treated.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Fachklinik Bad Bentheim - Dermatologische Studienambulanz
Bensheim, 48455
Rothhaar Studien GmbH
Berlin, 10783
About this study
Official title: 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)
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.
Read more
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).
Read the 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
- Being tested
- IMP Application KM-001, Chemistry, Hematology, Urinalysis, Serelogy
- Medical subject headings
- Neurodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMP Application KM-001Drug
Also called Experimental drug administration
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.
ChemistryDiagnostic test
Also called Blood test
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.
HematologyDiagnostic test
Also called 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.
UrinalysisDiagnostic test
Also called Urine 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.
SerelogyDiagnostic test
Also called Blood test
Patients will provide a blood sample for serelogy test at day -14 (screening visit)
12-Lead ECGDiagnostic test
patients will undergo an ECG examination on days -14 (screening visit), and day 28 (end of treatment visit).
Pregnancy testDiagnostic test
Also called Blood test
Women of child-bearing potential only will provide at all the on-site visits b-hCG concentration will be tested
Blood PK samplingDiagnostic test
PK test will be performed on day 1, 7, 28, 35 and on ET visit
Physical ExaminationProcedure or surgery
patients will undergo a physical examination on all the clinical visits
Vital signaProcedure or surgery
patient's vital signs will be measured on all the clinical visits
Investigator's Global AssessmentDiagnostic test
Also called score
patient's disease evaluations will be evaluated on all the clinical visits
Itch Assessment via PP-NRSjDiagnostic test
Also called score
patient's disease evaluations will be evaluated on all the clinical visits
E-diary dataOther
The patient will record IMP adminidsration and AE events in a diary every day throughout the all study period
| Study group | Role | What they receive |
|---|---|---|
| KM-001 0.3% | Experimental | KM-001 0.3% cream will be applied to the affected area twice daily for 4 consecutive weeks. Receives: 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 1% | Experimental | KM-001 0.3% cream will be applied to the affected area twice daily for 4 consecutive weeks. Receives: 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 arm | Placebo comparator | Vehicle cream will be applied to the affected area twice daily for 4 consecutive weeks. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoint - Will be assessed through collection and analysis of adverse events
Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Measured: 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
Measured: 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.
Measured: 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.
Measured: up to 14 days
Safety endpoint- Serology blood test- HIV
HIV will be prformed at screening visit. laboratory measurements will be assessed and listed.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: up to 4 weeks
KM-001 plasma levels (PK) - Cmax
CMAX measurement (mg/ml)
Measured: Up to 5 weeks
KM-001 plasma levels (PK) - Tmax
Tmax measurement (h)
Measured: Up to 5 weeks
KM-001 plasma levels (PK) - AUC 0-t
AUC measurement (mg*h/L)
Measured: Up to 5 weeks
Secondary outcomes (3)
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").
Measured: 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
Measured: 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
Measured: up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start24 May 2022
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen Simplex ChronicusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Topical application of approximately 1 g cream per defined treatment area (2% body surface area \[BSA\] including target lesion \[minimum 0.5% to maximum 2% BSA\]) twice daily during a 4-week treatment period (on Days 0 to 27 and one additional application in the morning of Day 28, i.e., 57 treatments)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orvida Pharma (formerly Kamari Pharma)
- Sponsor type
- Research network
- Collaborators
- Bioskin GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454462
- Sponsor's protocol ID
- KM-001AB1
- Status last verified
- Mar 2024
- First submitted
- 29 Jun 2022
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05454462
- Acronym / sponsor ID
- KM-001AB1
- Conditions
- Lichen Simplex Chronicus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Orvida Pharma (formerly Kamari Pharma)Research network
- Collaborators
- Bioskin GmbH
- Study start
- 24 May 2022 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Topical application of approximately 1 g cream per defined treatment area (2% body surface area [BSA] including target lesion [minimum 0.5% to maximum 2% BSA]) twice daily during a 4-week treatment period (on Days 0 to 27 and one additional application in the morning of Day 28, i.e., 57 treatments)
| Arm | Type | Receives |
|---|---|---|
| KM-001 0.3% | Experimental | 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 dataKM-001 0.3% cream will be applied to the affected area twice daily for 4 consecutive weeks. |
| KM-001 1% | Experimental | 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 dataKM-001 0.3% cream will be applied to the affected area twice daily for 4 consecutive weeks. |
| Vehicle arm | Placebo comparator | 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 dataVehicle cream will be applied to the affected area twice daily for 4 consecutive weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Read, understood, and signed an ICF before any investigational procedure(s) are performed.
- Male or female and aged ≥18 to 75 years at the time of screening.
- Chronic moderate to severe pruritus defined as:
- Clinical diagnosis of LSC for at least 8 weeks prior to screening:
- Female patients of childbearing potential1 must use a highly effective birth control method(failure rate ˂1% per year when used consistently and correctly) (17) throughout the study and for at least 4 weeks after last application of IMP.
Key exclusion criteria (32 listed)
- Known hypersensitivity or any suspected cross-allergy to the active pharmaceutical ingredient (API) and/or excipients.
- Chronic pruritus resulting from another active condition other than LSC such as, but not limited to, psoriasis, atopic dermatitis, lichen planus contact dermatitis, folliculitis, habitual picking, bullous autoimmune disease, neuropathy.
- Genital, anal or scalp LSC.
- History of or current confounding skin condition (psoriasis, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], chronic actinic dermatitis with [present or previous] skin cancer on the site of LSC, bullous disorders, dermatitis herpetiformis).
- Cutaneous infection within 1 week before the screening visit or any infection requiring treatment with oral, parenteral antibiotics, antivirals, antiparasitics or antifungals or any topical within 1 week before the screening visit. Patients may be rescreened once the infection has resolved.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMP Application KM-001Also: Experimental drug administrationKM-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. | Drug | KM-001 0.3%, KM-001 1%, Vehicle arm |
| ChemistryAlso: Blood testpatients 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 | KM-001 0.3%, KM-001 1%, Vehicle arm |
| HematologyAlso: Blood testpatients 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 | KM-001 0.3%, KM-001 1%, Vehicle arm |
| UrinalysisAlso: Urine testPatients 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 | KM-001 0.3%, KM-001 1%, Vehicle arm |
| SerelogyAlso: Blood testPatients will provide a blood sample for serelogy test at day -14 (screening visit) | Diagnostic test | KM-001 0.3%, KM-001 1%, Vehicle arm |
| 12-Lead ECGpatients will undergo an ECG examination on days -14 (screening visit), and day 28 (end of treatment visit). | Diagnostic test | KM-001 0.3%, KM-001 1%, Vehicle arm |
| Pregnancy testAlso: Blood testWomen of child-bearing potential only will provide at all the on-site visits b-hCG concentration will be tested | Diagnostic test | KM-001 0.3%, KM-001 1%, Vehicle arm |
| Blood PK samplingPK test will be performed on day 1, 7, 28, 35 and on ET visit | Diagnostic test | KM-001 0.3%, KM-001 1%, Vehicle arm |
| Physical Examinationpatients will undergo a physical examination on all the clinical visits | Procedure or surgery | KM-001 0.3%, KM-001 1%, Vehicle arm |
| Vital signapatient's vital signs will be measured on all the clinical visits | Procedure or surgery | KM-001 0.3%, KM-001 1%, Vehicle arm |
| Investigator's Global AssessmentAlso: scorepatient's disease evaluations will be evaluated on all the clinical visits | Diagnostic test | KM-001 0.3%, KM-001 1%, Vehicle arm |
| Itch Assessment via PP-NRSjAlso: scorepatient's disease evaluations will be evaluated on all the clinical visits | Diagnostic test | KM-001 0.3%, KM-001 1%, Vehicle arm |
| E-diary dataThe patient will record IMP adminidsration and AE events in a diary every day throughout the all study period | Other | KM-001 0.3%, KM-001 1%, Vehicle arm |
Primary outcome
Safety endpoint - Will be assessed through collection and analysis of adverse events
Time frame: up to 7 weeks
Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Safety endpoint-Hematology blood test
Time frame: up to 7 weeks
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
Safety endpoint- Serology blood test - HBV
Time frame: up to 14 days
HBsAb,HBsAg, HBcAb will be prformed at screening visit. laboratory measurements will be assessed and listed.
Safety endpoint- Serology blood test- Hepatits C
Time frame: up to 14 days
Hepatits C virus antibody will be prformed at screening visit. laboratory measurements will be assessed and listed.
Safety endpoint- Serology blood test- HIV
Time frame: up to 14 days
HIV will be prformed at screening visit. laboratory measurements will be assessed and listed.
Safety endpoint-Chemistry
Time frame: up to 7 weeks
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.
Safety endpoin-Urine tests
Time frame: up to 7 weeks
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)
Safety endpoin-Pregnancy test
Time frame: up to 7 weeks
In women of child-bearing potential only. At all the on-site visits serum beta-human chorionic gonadotropin (b-hCG) concentration will be tested.
Safety endpoin-Vital signs- Pulse
Time frame: up to 7 weeks
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
Safety endpoin-Vital signs- Blood pressure
Time frame: up to 7 weeks
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
Safety endpoin-Vital signs- Body temperature
Time frame: up to 7 weeks
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.
Safety endpoin-Electrocardiogram
Time frame: up to 7 weeks
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
Safety endpoin-Physical examination
Time frame: up to 4 weeks
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.
KM-001 plasma levels (PK) - Cmax
Time frame: Up to 5 weeks
CMAX measurement (mg/ml)
KM-001 plasma levels (PK) - Tmax
Time frame: Up to 5 weeks
Tmax measurement (h)
KM-001 plasma levels (PK) - AUC 0-t
Time frame: Up to 5 weeks
AUC measurement (mg*h/L)
3 secondary outcomes
Efficacy endpoint will be assessed through collection and analysis of lesion Assessment-IGA
Time frame: up to 7 weeks
Efficacy endpoint will be assessed through collection and analysis of lesion Assessment- (PP-NRS)
Time frame: up to 7 weeks
Efficacy endpoint will be assessed through collection and analysis of lesion Assessment- (PP-NRS)- responders
Time frame: up to 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMP Application KM-001, Chemistry and Hematology in people with Lichen Simplex Chronicus, run by Orvida Pharma (formerly Kamari Pharma) at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety endpoint - Will be assessed through collection and analysis of adverse events (time frame: up to 7 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.