Atopic DermatitisPhase 2NCT03394677
Study of RVT-501 Topical Ointment in Pediatric Patients With Atopic Dermatitis
A Phase 2 study testing RVT-501 0.5% ointment in people with Atopic Dermatitis, run by Dermavant Sciences GmbH at 7 sites in 2 countries.
Trial summary
This is a multi-center, randomized, vehicle controlled, double-blind Phase 2 study in pediatric patients age 2-17 years old with mild to moderate atopic dermatitis. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- RVT-501 0.5% ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 25 Jan 2018to 2 Jul 2018
- Phase
- Phase 2
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female pediatric patients ages 2-17 years of age with confirmed diagnosis of atopic dermatitis by Hanifin and Rajka criteria [Hanifin, 1980].
- Patients with atopic dermatitis covering 5% to 40% of the body surface area (BSA) and with an Investigator Global Assessment (IGA) of 2 or 3 (mild or moderate atopic dermatitis) at Baseline. Scalp, palms, and soles should be excluded from the BSA calculation to determine eligibility at Baseline.
- Note: Patients with mild disease (IGA = 2) will be limited to approximately 25% of total enrollment.
- Females of childbearing potential and male patients who are engaging in sexual activity that could lead to pregnancy must use the following adequate birth control methods while on study and for 2 weeks after stopping the study drug. Acceptable contraception methods are:
- Male or male partner with vasectomy, OR
- Male condom AND partner use of one of the contraceptive options below:
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- Spermicide;
- Contraceptive subdermal implant that meets effectiveness criteria including a <1% rate of failure per year, as stated in the product label;
- Intrauterine device or intrauterine system that meets effectiveness criteria including <1% rate of failure per year, as stated in the product label;
- Oral contraceptive, either combined or progestogen alone;
- Injectable progestogen;
- Contraceptive vaginal ring;
- Percutaneous contraceptive patches.
- These allowed methods of contraception are only effective when used consistently, correctly, and in accordance with the product label. The Investigator is responsible for ensuring that patients understand how to properly use these methods of contraception.
- Non-child-bearing potential is defined as pre-menarchal or pre-menopausal females with a documented bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries) or hysterectomy, or hysteroscopic sterilization. Documented verbal history from the patient is acceptable.
- Patients who are abstinent are eligible, but they must agree to use of one of the birth control methods listed above if they start engaging in sexual activity that could lead to pregnancy during the study.
- Female subjects of childbearing potential must have a negative pregnancy test at Screening and Baseline (Day 0).
- History of atopic dermatitis and stable disease for at least 1 month according to the patient/caregiver.
- Patient, patient's parent(s), or legal representative must be capable of giving written informed consent or verbal assent, as applicable, which includes compliance with the requirements and restrictions listed in the consent/assent form; written informed consent must be obtained prior to any study related procedures.
Who cannot join
- A positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis C antibody result, or positive human immunodeficiency virus (HIV) antibody at Screening.
- Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5x the upper limit of normal (ULN).
- Screening total bilirubin > 1.5x ULN; total bilirubin > ULN and ≤ 1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%.
- Patients with a skin condition such as Kaposi's varicelliform eruption, scabies, molluscum contagiosum, impetigo, psoriasis, severe acne, connective tissue disorder, or Netherton's syndrome, or any other disease that could impact study evaluations.
- Use of any prohibited medication.
- Prohibited concomitant medications, therapy, etc. during the defined period are as listed in the bullets below. If a patient requires any of these medications throughout the study period, he/she may be excluded from or discontinued from the study, at the discretion of the Investigator and medical monitor.
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- From 6 months prior to the first application of study drugs to the completion of the
- Follow-up visit or discontinuation:
- Biological products that might have significantly affected the evaluation of atopic dermatitis condition (e.g., tumor necrosis factor [TNF] inhibitors, anti- immunoglobulin [Ig]E antibodies, anti-CD20 antibodies, anti-interleukin [IL]-4 receptor).
- From 28 days prior to the first application of study drug until the completion of the Follow- up visit or discontinuation:
- Corticosteroid preparations (oral, injection, and suppository preparations) and topical corticosteroids that were classified as super-high potency (clobetasol propionate). Eye drop and nasal preparations are allowed. Inhaled preparations are allowed if used for a stable condition and at a stable dose for > 28 days before Screening, and are continued at the same dose throughout the study.
- Oral preparations and injections of immunosuppressants (cyclosporine, methotrexate, azathioprine, tacrolimus, etc.);
- Excessive sun exposure, tanning booth, other ultraviolet (UV) light source and phototherapy including psoralen and ultraviolet A (PUVA) therapy.
- From 14 days prior to the first application of the study drug to the completion of the
- Follow-up visit or discontinuation:
- Herbal medicines for atopic dermatitis (topical and oral preparations), unless specifically approved by the sponsor;
- Eucrisa™ (crisaborole) and any other topical phosphodiesterase 4 (PDE4) inhibitor;
- Tacrolimus and pimecrolimus cream and/or ointment;
- Topical corticosteroids that were classified as low, medium, or high potency (fluocinonide, triamcinolone acetonide, desonide, hydrocortisone). Eye drops and nasal preparations are allowed.
- From 7 days prior to the first application of the study drug to the completion of the
- Follow-up visit or discontinuation:
- Oral or intravenous antibiotics, antifungal or antivirus medications
- Antihistamines/anti-allergics (oral, topical and injections): diphenhydramine, chlorpheniramine maleate, hydroxyzine).
- NOTE: The following antihistamines are allowed:
- Loratadine, fexofenadine hydrochloride, cetirizine hydrochloride
- Pregnant or lactating females.
- History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or medical monitor, contraindicates their participation.
- The patient has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
- Current or a history of cancer within 5 years.
- Patients with active infection in atopic dermatitis areas requiring antibiotics, antifungals, or antiviral agents within 7 days of Baseline (Day 0).
- Patients with pruritus due to conditions other than atopic dermatitis that, in the opinion of the Investigator, would either interfere with study evaluations or affect the safety of the patient.
- Patients with advanced disease or recent abnormal laboratory test values that could affect the safety of the patient or the implementation of this study, as determined by medical records.
- History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to PDE4 inhibitors.
- Prior exposure to RVT-501.
- Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities or laboratory abnormalities that will affect the health of the patient or interfere with interpretation of the results.
- The patient has excessive sun exposure, is planning a trip to a sunny climate that would involve excessive sun exposure, or used tanning booths within 28 days prior to Baseline (Day 0) or is not willing to minimize natural and artificial sunlight exposure during the study.
- Other Eligibility Criteria Considerations:
- To assess any potential impact on patient eligibility with regard to safety, the Investigator must refer to the following document for detailed information regarding warnings, precaustions, contraindications, adverse events, and other significant data pertaining to the investigational product being used in the study:
- The current version of the RVT-501 Investigator's Brochure.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Dermavant Investigational Site
Dallas, Texas, 75230
Dermavant Investigational Site
Los Angeles, California, 90045
Dermavant Investigational Site
Oklahoma City, Oklahoma, 73118
Dermavant Investigational Site
Portland, Oregon, 97223
Dermavant Investigational Site
San Antonio, Texas, 78213
Canada2 sites
Dermavant Investigational Site
Montreal, Quebec, H2K 4L5
Dermavant Investigational Site
Surrey, British Columbia, V3R 6A7
About this study
Official title: Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerabililty of RVT-501 Topical Ointment in Pediatric Patients With Mild to Moderate Atopic Dermatitis
This is a multi-center, randomized, vehicle controlled, double-blind Phase 2 study in pediatric patients age 2-17 years old with mild to moderate atopic dermatitis.
Read the detailed description
The purpose of this study is to evaluate the safety, efficacy, and tolerability of a 0.5% BID concentration of RVT-501 in pediatric patients 2-17 years of age with mild to moderate atopic dermatitis. The pharmacokinetics of RVT-501 will also be evaluated in patients 2-11 years of age.
- Conditions
- Atopic Dermatitis
- Being tested
- RVT-501 0.5% ointment, Vehicle ointment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVT-501 0.5% ointmentDrug
Patients will receive RVT-501 0.5% ointment twice daily (BID) for 4 weeks.
Vehicle ointmentDrug
Placebo comparator - ointment twice daily (BID) for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| RVT-501 0.5% ointment | Experimental | Subjects will receive RVT-501 0.5% ointment twice daily (BID) for 4 weeks. Receives: Drug: RVT-501 0.5% ointment |
| RVT-501 vehicle ointment | Placebo comparator | Subjects will receive RVT-501 vehicle ointment twice daily (BID) for 4 weeks. Receives: Drug: Vehicle ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Investigator Global Assessment (IGA) score
Efficacy will be assessed by determining the proportion of patients who achieve an Investigator Global Assessment (IGA) score of 0 or 1 and at least a 2-point improvement in IGA at Week 4. The IGA will be assessed at every study visit. The IGA is a 5-point morphological assessment of overall disease severity and will be determined according to the following categories: 0-clear; 1-almost clear; 2-mild disease; 3-moderate disease; 4-severe disease.
Measured: 28 days
Efficacy - Eczema Area Severity Index (EASI) score
Efficacy will be assessed by determining the proportion of patients who achieve a 50% reduction in Eczema Area Severity Index score (EASI-50) at Week 4.The EASI will be assessed at every study visit. It quantifies the severity of a patient's atopic dermatitis based on both lesion severity and the percent of body surface area affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region relative to the whole body.
Measured: 28 days
Efficacy - Peak Pruritus Numeric Rating Scale (NRS)
Efficacy will be assessed as change from Baseline to Week 4 in peak pruritus as measured with the 24-hour Peak Pruritus Numeric Rating Scale (NRS). Peak Pruitus NRS will be measured at each visit. The assessment consists of a patient-rated scale of 0-10, where 0 is "No itch" and 10 is the "Worst itch possible."
Measured: 28 days
Efficacy - Whole body surface area (BSA) affected
This exploratory endpoint will be evaluated as the change in total score from Baseline at all visits in whole body BSA (body surface area) affected. Whole body BSA affected will be assessed at every visit.
Measured: 28 days
Secondary outcomes (3)
Frequency and severity of adverse events (local and systemic)
Adverse events will be coded using the most current release of MedDRA® (Medical Dictionary for Regulatory Activities). The number and proportion of subjects with adverse events will be summarized by treatment, system organ class, and preferred term for all adverse events, all adverse events considered by the investigator to be related to study drug, all serious adverse events, and all adverse events leading to study drug discontinuation
Measured: 28 days
Plasma concentrations of RVT-501
PK samples will be collected only at the Week 1 visit in 2-11 year old patients. RVT-501 will be measured in plasma by validated assay to confirm exposure.These plasma concentrations will be listed by metabolite, subject, treatment, and time; and will be summarized by analyte and time.
Measured: 7 days
Plasma concentrations of M11 metabolite
PK samples will be collected only at the Week 1 visit in 2-11 year old patients. The M11 metabolite will be measured in plasma by validated assay to confirm exposure. These plasma concentrations will be listed by metabolite, subject, treatment, and time; and will be summarized by metabolite, treatment and time.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start25 Jan 2018
- Primary completion2 Jul 2018
- Study completion2 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermavant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Lee, MD, PhD, Study chair, Dermavant Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394677
- Sponsor's protocol ID
- RVT-501-2004
- Status last verified
- Jul 2018
- First submitted
- 21 Dec 2017
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerabililty of RVT-501 Topical Ointment in Pediatric Patients With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03394677
- Acronym / sponsor ID
- RVT-501-2004
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Dermavant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 9 Jan 2018 (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 multi-center, randomized, vehicle controlled, double-blind Phase 2 study in pediatric patients age 2-17 years old with mild to moderate atopic dermatitis.
Detailed description
The purpose of this study is to evaluate the safety, efficacy, and tolerability of a 0.5% BID concentration of RVT-501 in pediatric patients 2-17 years of age with mild to moderate atopic dermatitis. The pharmacokinetics of RVT-501 will also be evaluated in patients 2-11 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RVT-501 0.5% ointment | Experimental | Drug: RVT-501 0.5% ointmentSubjects will receive RVT-501 0.5% ointment twice daily (BID) for 4 weeks. |
| RVT-501 vehicle ointment | Placebo comparator | Drug: Vehicle ointmentSubjects will receive RVT-501 vehicle ointment twice daily (BID) for 4 weeks. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- Male and female pediatric patients ages 2-17 years of age with confirmed diagnosis of atopic dermatitis by Hanifin and Rajka criteria [Hanifin, 1980].
- Patients with atopic dermatitis covering 5% to 40% of the body surface area (BSA) and with an Investigator Global Assessment (IGA) of 2 or 3 (mild or moderate atopic dermatitis) at Baseline. Scalp, palms, and soles should be excluded from the BSA calculation to determine eligibility at Baseline.
- Note: Patients with mild disease (IGA = 2) will be limited to approximately 25% of total enrollment.
- Females of childbearing potential and male patients who are engaging in sexual activity that could lead to pregnancy must use the following adequate birth control methods while on study and for 2 weeks after stopping the study drug. Acceptable contraception methods are:
- These allowed methods of contraception are only effective when used consistently, correctly, and in accordance with the product label. The Investigator is responsible for ensuring that patients understand how to properly use these methods of contraception.
Key exclusion criteria (39 listed)
- A positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis C antibody result, or positive human immunodeficiency virus (HIV) antibody at Screening.
- Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5x the upper limit of normal (ULN).
- Screening total bilirubin > 1.5x ULN; total bilirubin > ULN and ≤ 1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%.
- Patients with a skin condition such as Kaposi's varicelliform eruption, scabies, molluscum contagiosum, impetigo, psoriasis, severe acne, connective tissue disorder, or Netherton's syndrome, or any other disease that could impact study evaluations.
- Use of any prohibited medication.
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 |
|---|---|---|
| RVT-501 0.5% ointmentPatients will receive RVT-501 0.5% ointment twice daily (BID) for 4 weeks. | Drug | RVT-501 0.5% ointment |
| Vehicle ointmentPlacebo comparator - ointment twice daily (BID) for 4 weeks. | Drug | RVT-501 vehicle ointment |
Primary outcome
Efficacy - Investigator Global Assessment (IGA) score
Time frame: 28 days
Efficacy will be assessed by determining the proportion of patients who achieve an Investigator Global Assessment (IGA) score of 0 or 1 and at least a 2-point improvement in IGA at Week 4. The IGA will be assessed at every study visit. The IGA is a 5-point morphological assessment of overall disease severity and will be determined according to the following categories: 0-clear; 1-almost clear; 2-mild disease; 3-moderate disease; 4-severe disease.
Efficacy - Eczema Area Severity Index (EASI) score
Time frame: 28 days
Efficacy will be assessed by determining the proportion of patients who achieve a 50% reduction in Eczema Area Severity Index score (EASI-50) at Week 4.The EASI will be assessed at every study visit. It quantifies the severity of a patient's atopic dermatitis based on both lesion severity and the percent of body surface area affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region relative to the whole body.
Efficacy - Peak Pruritus Numeric Rating Scale (NRS)
Time frame: 28 days
Efficacy will be assessed as change from Baseline to Week 4 in peak pruritus as measured with the 24-hour Peak Pruritus Numeric Rating Scale (NRS). Peak Pruitus NRS will be measured at each visit. The assessment consists of a patient-rated scale of 0-10, where 0 is "No itch" and 10 is the "Worst itch possible."
Efficacy - Whole body surface area (BSA) affected
Time frame: 28 days
This exploratory endpoint will be evaluated as the change in total score from Baseline at all visits in whole body BSA (body surface area) affected. Whole body BSA affected will be assessed at every visit.
3 secondary outcomes
Frequency and severity of adverse events (local and systemic)
Time frame: 28 days
Plasma concentrations of RVT-501
Time frame: 7 days
Plasma concentrations of M11 metabolite
Time frame: 7 days
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 19 Jul 2018.
- Dermavant Sciences Official WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
James Lee, MD, PhD study chair
Dermavant Sciences, Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RVT-501 0.5% ointment in people with Atopic Dermatitis, run by Dermavant Sciences GmbH at 7 sites in 2 countries.
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 19 inclusion and 39 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 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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 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?
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?
Efficacy - Investigator Global Assessment (IGA) score (time frame: 28 days). The study lists 4 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 19 Jul 2018.