Dermatitis, AtopicPhase 1/2NCT04220411
A Study for AR100DP1 in Mild to Moderate Atopic Dermatitis (AD)
A Phase 1/2 study testing AR100DP1 in people with Dermatitis, Atopic, run by Arjil Pharmaceuticals LLC at 1 site in Taiwan.
Trial summary
This is a Phase I/IIa Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of AR100DP1 in Health Subjects, and Subjects with Mild to Moderate Atopic Dermatitis. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- AR100DP1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Dec 2020to 13 Jun 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase I:
- Dated and signed informed consent
- Either gender, ≥ 20 years old (the legal age of consent majority is 20 years old in Taiwan)
- Healthy subjects, who have no clinically relevant abnormalities, identified by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
- Healthy skin on which reddening can be easily recognized in the area of the test fields, evaluated by the investigator
Show all 23Show fewer
- Subject of childbearing potential must agree to use abstinence to intercourse, or highly effective contraceptives from signing informed consent to 14 days after the last dose of study drug administration
- At least two forms of effective birth control must be adopted for contraception, and one of which must be a barrier method. Acceptable forms include:
- Established use of oral, injected or implanted hormonal methods of contraception
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: condom (highly recommended with spermicide), or occlusive cap (diaphragm or cervical/vault caps)
- Phase IIa:
- Dated and signed informed consent
- Either gender, ≥ 20 years old (the legal age of consent majority is 20 years old in Taiwan)
- Confirmed clinical diagnosis of atopic dermatitis (based on the criteria of Hanifin and Rajka for AD)
- With at least 0.5% body surface area (BSA) as target lesion area(s)
- Clinical diagnosis of AD that has been clinically stable, which means the IGA score stays as 2 or 3 when evaluated for ≥ 4 weeks at the investigator's discretion prior to Screening Visit
- With Investigator's Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at screening
- Subject of childbearing potential must agree to use abstinence to intercourse, or highly effective contraceptives from signing informed consent to 14 days after the last dose of study drug administration
- At least two forms of effective birth control must be adopted for contraception, and one of which must be a barrier method. Acceptable forms include:
- Established use of oral, injected or implanted hormonal methods of contraception
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: condom (highly recommended with spermicide), or occlusive cap (diaphragm or cervical/vault caps)
Who cannot join
- Phase I:
- Subjects who have any visible skin disease at the application site which, in the opinion of the investigator, will interfere with the evaluation of the test site reaction
- Subjects who have a history of AD, psoriasis and/or active AD/eczema
- Subjects who have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing)
- Phase IIa:
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- Unstable or actively infected AD judged by the investigator.
- Active or potentially recurrent dermatologic condition other than atopic dermatitis that may confound evaluation (e.g. fungal infection), judged by the investigator.
- Received systemic medication including corticosteroid, immunosuppressant, anti-histamine, phototherapy, or other therapy, which could affect AD within 4 weeks before Screening. However, subjects are allowed to enter the study if subjects have been taking at least 2 weeks of fixed dose anti-histamine prior to Screening and this application does not affect the study judged by the investigator
- Received topical medication including corticosteroid, immunosuppressant, anti-histamine, phototherapy, calcineurin inhibitors, or other therapy for AD on the target lesion area(s) within 1 week before Screening
- The following exclusion criteria are applied for all subjects in Phase I/IIa study:
- Plan to receive immunosuppressive agents (including azathioprine, mycophenolate, cyclophosphamide, chlorambucil, methotrexate, cyclosporine), or systemic steroid with equivalent dosage higher than prednisolone 30 mg/day for more than 14 days at Screening
- Unwilling or unable to comply with the criteria in Life Style Guidelines during the study
- History of use of biologic therapy (including intravenous immunoglobulin) within 12 weeks or 5 half-lives (whichever is longer) prior to Screening
- Received any other investigational drug within 4 weeks prior to Screening
- Required or received systemic CYP3A4 inhibitors with strong potency within 1 week prior to screening, including but not limited to clarithromycin, itraconazole, nefazodone and atazanavir, evaluated by the investigator
- Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within 5 years before screening
- Had surgery within 4 weeks prior to Screening Visit, or plan to have surgery during the study
- Allergies requiring acute or chronic treatment at the investigator's discretion
- Known hypersensitivity to any of the components of the study drug
- Active clinically serious infection or history of human immunodeficiency virus (HIV) infection
- Any of the following serum test abnormalities:
- Total bilirubin > 1.5 × ULN
- AST or ALT > 3.0 × ULN
- Serum albumin < 2.5 g/dL
- Creatinine > 1.5 × ULN
- Any other ≥ Grade 2 (grading of vaccine clinical trials for Phase I and NCI-CTCAE v5.0 for Phase IIa) laboratory abnormality at baseline (other than those listed above)
- With ongoing acute diseases or within the past 2 years serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association (NYHA) grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject
- Female subject who is lactating or has positive urine pregnancy test at screening
- Other conditions not suitable for participating in this study judged by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/IIa Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of AR100DP1 in Healthy Subjects, and Subjects With Mild to Moderate Atopic Dermatitis
This is a Phase I/IIa Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of AR100DP1 in Health Subjects, and Subjects with Mild to Moderate Atopic Dermatitis.
Read the detailed description
This phase I/IIa study will be composed of a Phase I study, which includes 14 days of treatment with AR100DP1 followed by 2 weeks of follow-up period to find the maximum tolerated dose (MTD) of AR100DP1 and a following single-arm Phase IIa study with 28 days of treatment followed by 2 weeks of follow-up period to evaluate the efficacy of AR100DP1 with the recommended Phase II dose (RP2D) in treating atopic dermatitis on target lesion. Target lesion area(s) is defined as one or multiple patches of lesion areas selected by the investigator for topical administration of AR100DP1. The size of target lesion area(s) is 0.5-5% body surface area (BSA) and the maximum is 750 cm2 (maximal treated area, inclusive) in this study. Eligible healthy subjects in Phase I will have the test skin area(s) of 750 cm2 from chest and abdomen. Eligible subjects with mild to moderate AD in Phase IIa will have target lesion area(s) selected by the investigator. The skin area treated with AR100DP1 will be recorded for AR100DP1 topical administration before dosing. AR100DP1 should be topically administered twice daily on the test skin area(s) of 750 cm2 of eligible healthy subjects for 14 days in Phase I study. The administration of AR100DP1 should be topically applied twice daily on target lesion area(s) (0.5-5% BSA, maximum as 750 cm2, inclusive) of eligible subjects with mild to moderate AD for 28 days in Phase IIa study.
- Conditions
- Dermatitis, Atopic
- Being tested
- AR100DP1
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR100DP1Drug
topical ointment
| Study group | Role | What they receive |
|---|---|---|
| AR100DP1 (1.25%)_Phase I | Experimental | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25). Receives: Drug: AR100DP1 |
| AR100DP1 (2.5%)_Phase I | Experimental | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5). Receives: Drug: AR100DP1 |
| AR100DP1 (5%)_Phase I | Experimental | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125). Receives: Drug: AR100DP1 |
| AR100DP1 (5%)_Phase IIa | Experimental | Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125). Receives: Drug: AR100DP1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With DLTs
Phase I study included 14 days of treatment with AR100DP1, followed by 2 weeks of follow-up period to find the maximum tolerated dose (MTD) of AR100DP1.
DLTs were defined as any adverse event (AE) ≥ Grade 2 (Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, issued by United States Food and Drug Administration in September 2007), that was considered to be causally related (possibly, probably, or definitely related) to AR100DP1 as judged by the investigator up to Day 29. The definition of Grade 5 (death related to AE) was added to this grading system as it was not defined in the guidance. (reported in the subsequent Primary Outcome Measure). MTD is defined as the highest dose level at which < 2 of 6 subjects experienced a dose-limiting toxicity (DLT).
Measured: up to Day 29 for each cohort in phase I
Maximum Tolerated Dose (MTD) of AR100DP1
Per protocol, MTD is defined as the highest dose level at which < 2 of 6 subjects experienced a dose-limiting toxicity (DLT).
MTD was determined by testing increasing doses up to 125 mg/day via topical administration on AR100DP1_1.25%, 2.5%, and 5% groups with 3 to 6 subjects each.
DLTs were defined as any adverse event (AE) ≥ Grade 2 (Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, issued by United States Food and Drug Administration in September 2007), that was considered to be causally related (possibly, probably, or definitely related) to AR100DP1 as judged by the investigator up to Day 29. The definition of Grade 5 (death related to AE) was added to this grading system as it was not defined in the guidance. (reported in the previous Primary Outcome Measure).
Measured: up to Day 29 for each cohort in phase I
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 or 1 on Day 29 (Phase IIa)
The IGA is a 5-point scale that provides a global clinical assessment of AD severity based on an ordinal scale, scored by the investigator. The scores of IGA are 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (Severe).
Measured: Day 29 (Phase IIa)
Secondary outcomes (18)
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
The IGA is a 5-point scale that provides a global clinical assessment of AD severity based on an ordinal scale, scored by the investigator. The scores of IGA are 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (Severe).
Measured: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)
Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions
The pruritus NRS is comprised itch level grading from the numbers 0 ("no itch") to 10 ("worst imaginable itch"). Subjects are asked to rate the intensity of their itch by visits.
Measured: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)
Change of IgE Compared to Baseline (Day 1)
Measured: Day 15 and 29 (Phase IIa)
Fold Change of IL-4 Compared to Baseline (Day 1 )
Measured: Day 15 and 29 (Phase IIa)
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
4 symptoms of atopic dermatitis (erythema, edema, excoriation and lichenification) will be evaluated on all target lesions and graded from 0 to 3 (none, mild, moderate and severe, respectively), with half points allowed
Measured: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)
Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM)
POEM is a validated, patient-derived assessment measure for monitoring atopic eczema severity , available at the HOME (Harmonising Outcome Measures for Eczema) group. It contains seven symptoms of AD on 5-point (0 to 4) scale with total score 0 to 28 during the study.
A higher score means a worse outcome, whereas a lower score is a better outcome.
Measured: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)
Number of Subjects With AE and SAE
Measured: Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature.
Measured: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)
Number of Subjects With Physical Examination Abnormalities
Physical examination will include the following items: general appearance, skin, eyes, ears, nose, throat, head and neck, heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological and others.
Measured: Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
Number of Subjects With 12-lead ECG Abnormalities
ECG will be evaluated by the investigators and noted as "Normal", "Abnormal, non-clinical significant (NCS)" or "Abnormal, clinical significant (CS)"
Measured: Day 1, Day 8, Day 15, Day 22, Day 29 (Phase I); Day 1, Day 8, Day 15, Day 22, Day 29, Day 43 (Phase IIa)
Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology)
Laboratory tests include hematology (hemoglobin, hematocrit, RBC, platelet, WBC with different counts), biochemistry (total bilirubin, AST, ALT, serum creatinine and albumin)
Measured: Day 8 to Day 29 (Phase I); Day 8 to Day 43 (Phase IIa)
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature.
Measured: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)
Change From Baseline in Vital Signs (Pulse Rate)
Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature.
Measured: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)
Change From Baseline in Vital Signs (Respiration Rate)
Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature.
Measured: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)
Change From Baseline in Vital Signs (Body Temperature)
Vital signs measurement will consist of systolic/diastolic blood pressure, respiratory rate, pulse rate or heart rate, and body temperature.
Measured: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)
Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry)
Laboratory tests include hematology (hemoglobin, hematocrit, RBC, platelet, WBC with different counts), biochemistry (total bilirubin, AST, ALT, serum creatinine and albumin)
Measured: Day 8 to Day 29 (Phase I); Day 8 to Day 43 (Phase IIa)
Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
The IGA is a 5-point scale that provides a global clinical assessment of AD severity based on an ordinal scale, scored by the investigator. The scores of IGA are 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (Severe).
Measured: Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa)
Measured: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start8 Dec 2020
- Primary completion29 Dec 2021
- Study completion13 Jun 2022
Why it stopped: Due to the two AEs in Phase IIa study, recruiting was stopped for safety sake. The study was currently terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dermatitis, AtopicStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase I: conventional 3+3 design of dose escalation Phase IIa: single-arm
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arjil Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220411
- Sponsor's protocol ID
- AR100DP1-01
- Status last verified
- Dec 2023
- First submitted
- 3 Jan 2020
- Last updated
- 11 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of AR100DP1 in Healthy Subjects, and Subjects With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04220411
- Acronym / sponsor ID
- AR100DP1-01
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the two AEs in Phase IIa study, recruiting was stopped for safety sake. The study was currently terminated.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Arjil Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Posted 11 Dec 2023
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 I/IIa Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of AR100DP1 in Health Subjects, and Subjects with Mild to Moderate Atopic Dermatitis.
Detailed description
This phase I/IIa study will be composed of a Phase I study, which includes 14 days of treatment with AR100DP1 followed by 2 weeks of follow-up period to find the maximum tolerated dose (MTD) of AR100DP1 and a following single-arm Phase IIa study with 28 days of treatment followed by 2 weeks of follow-up period to evaluate the efficacy of AR100DP1 with the recommended Phase II dose (RP2D) in treating atopic dermatitis on target lesion. Target lesion area(s) is defined as one or multiple patches of lesion areas selected by the investigator for topical administration of AR100DP1. The size of target lesion area(s) is 0.5-5% body surface area (BSA) and the maximum is 750 cm2 (maximal treated area, inclusive) in this study. Eligible healthy subjects in Phase I will have the test skin area(s) of 750 cm2 from chest and abdomen. Eligible subjects with mild to moderate AD in Phase IIa will have target lesion area(s) selected by the investigator. The skin area treated with AR100DP1 will be recorded for AR100DP1 topical administration before dosing. AR100DP1 should be topically administered twice daily on the test skin area(s) of 750 cm2 of eligible healthy subjects for 14 days in Phase I study. The administration of AR100DP1 should be topically applied twice daily on target lesion area(s) (0.5-5% BSA, maximum as 750 cm2, inclusive) of eligible subjects with mild to moderate AD for 28 days in Phase IIa study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Phase I: conventional 3+3 design of dose escalation Phase IIa: single-arm
| Arm | Type | Receives |
|---|---|---|
| AR100DP1 (1.25%)_Phase I | Experimental | Drug: AR100DP1Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 1.25% AR100DP1 topical administration is 31.25 mg/day (1.25% × 1,250 × 2 = 31.25). |
| AR100DP1 (2.5%)_Phase I | Experimental | Drug: AR100DP1Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5). |
| AR100DP1 (5%)_Phase I | Experimental | Drug: AR100DP1Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125). |
| AR100DP1 (5%)_Phase IIa | Experimental | Drug: AR100DP1Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 5% AR100DP1 topical administration is 125 mg/day (5% × 1,250 × 2 = 125). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Dated and signed informed consent
- Either gender, ≥ 20 years old (the legal age of consent majority is 20 years old in Taiwan)
- Healthy subjects, who have no clinically relevant abnormalities, identified by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
- Healthy skin on which reddening can be easily recognized in the area of the test fields, evaluated by the investigator
Key exclusion criteria (30 listed)
- Subjects who have any visible skin disease at the application site which, in the opinion of the investigator, will interfere with the evaluation of the test site reaction
- Subjects who have a history of AD, psoriasis and/or active AD/eczema
- Subjects who have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing)
- Unstable or actively infected AD judged by the investigator.
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 |
|---|---|---|
| AR100DP1topical ointment | Drug | AR100DP1 (1.25%)_Phase I, AR100DP1 (2.5%)_Phase I, AR100DP1 (5%)_Phase I, AR100DP1 (5%)_Phase IIa |
Primary outcome
Number of Subjects With DLTs
Time frame: up to Day 29 for each cohort in phase I
Phase I study included 14 days of treatment with AR100DP1, followed by 2 weeks of follow-up period to find the maximum tolerated dose (MTD) of AR100DP1. DLTs were defined as any adverse event (AE) ≥ Grade 2 (Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, issued by United States Food and Drug Administration in September 2007), that was considered to be causally related (possibly, probably, or definitely related) to AR100DP1 as judged by the investigator up to Day 29. The definition of Grade 5 (death related to AE) was added to this grading system as it was not defined in the guidance. (reported in the subsequent Primary Outcome Measure). MTD is defined as the highest dose level at which < 2 of 6 subjects experienced a dose-limiting toxicity (DLT).
Maximum Tolerated Dose (MTD) of AR100DP1
Time frame: up to Day 29 for each cohort in phase I
Per protocol, MTD is defined as the highest dose level at which < 2 of 6 subjects experienced a dose-limiting toxicity (DLT). MTD was determined by testing increasing doses up to 125 mg/day via topical administration on AR100DP1_1.25%, 2.5%, and 5% groups with 3 to 6 subjects each. DLTs were defined as any adverse event (AE) ≥ Grade 2 (Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, issued by United States Food and Drug Administration in September 2007), that was considered to be causally related (possibly, probably, or definitely related) to AR100DP1 as judged by the investigator up to Day 29. The definition of Grade 5 (death related to AE) was added to this grading system as it was not defined in the guidance. (reported in the previous Primary Outcome Measure).
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 or 1 on Day 29 (Phase IIa)
Time frame: Day 29 (Phase IIa)
The IGA is a 5-point scale that provides a global clinical assessment of AD severity based on an ordinal scale, scored by the investigator. The scores of IGA are 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (Severe).
18 secondary outcomes
Percentage of Subjects With the Investigator's Global Assessment (IGA) Score of 0 ~ 4 (Phase IIa)
Time frame: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)
Change From Baseline in Pruritus Numerical Rating Scale (NRS) of Itch Level on Target Lesions
Time frame: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)
Change of IgE Compared to Baseline (Day 1)
Time frame: Day 15 and 29 (Phase IIa)
Fold Change of IL-4 Compared to Baseline (Day 1 )
Time frame: Day 15 and 29 (Phase IIa)
Change From Baseline in Signs of Atopic Dermatitis (Erythema, Edema, Excoriation and Lichenification) on Target Lesions
Time frame: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)
Change From Baseline in the Total Score of Patient-Oriented Eczema Measure (POEM)
Time frame: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)
Number of Subjects With AE and SAE
Time frame: Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
Change From Baseline in Vital Signs (Systolic Blood Pressure)
Time frame: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)
Number of Subjects With Physical Examination Abnormalities
Time frame: Day -14 to 29 (Phase I); Day -14 to 43 (Phase IIa)
Number of Subjects With 12-lead ECG Abnormalities
Time frame: Day 1, Day 8, Day 15, Day 22, Day 29 (Phase I); Day 1, Day 8, Day 15, Day 22, Day 29, Day 43 (Phase IIa)
Number of Subjects With Clinically Significant Laboratory Abnormalities (Hematology)
Time frame: Day 8 to Day 29 (Phase I); Day 8 to Day 43 (Phase IIa)
Change From Baseline in Vital Signs (Diastolic Blood Pressure)
Time frame: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)
Change From Baseline in Vital Signs (Pulse Rate)
Time frame: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)
Change From Baseline in Vital Signs (Respiration Rate)
Time frame: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)
Change From Baseline in Vital Signs (Body Temperature)
Time frame: Day 1 to 29 (Phase I); Day 1 to 43 (Phase IIa)
Number of Subjects With Clinically Significant Laboratory Abnormalities (Biochemistry)
Time frame: Day 8 to Day 29 (Phase I); Day 8 to Day 43 (Phase IIa)
Percentage of Subjects Achieving the Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) on Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Time frame: Day 8, Day 15, Day 22, Day 36 and Day 43 (Phase IIa)
Change From Baseline of Target Lesion Area(s) on Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 (Phase IIa)
Time frame: Day 8, Day 15, Day 22, Day 29, Day 36 and Day 43 (Phase IIa)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AR100DP1 in people with Dermatitis, Atopic, run by Arjil Pharmaceuticals LLC at 1 site in Taiwan.
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 23 inclusion and 30 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: stopped early, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With DLTs (time frame: up to Day 29 for each cohort in phase I). The study lists 3 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 11 Dec 2023.