Atopic DermatitisPhase 2NCT02950922
Study of RVT-501 in Adult and Adolescent Subjects With Atopic Dermatitis
A Phase 2 study testing RVT-501 0.2% ointment and RVT-501 0.5% ointment in people with Atopic Dermatitis, run by Dermavant Sciences GmbH at 20 sites in 2 countries.
Trial summary
This is a multi-center, randomized, vehicle-controlled, double-blind Phase 2 study in adults and adolescent subjects with mild to moderate atopic dermatitis. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- RVT-501 0.2% ointment and RVT-501 0.5% ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Nov 2016to 3 Jul 2017
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Males and females with confirmed diagnosis of atopic dermatitis by Hanifin and Rajka criteria (Appendix 4: Criteria for Atopic Dermatitis Diagnosis).
- For adult subjects, the age range is 18 to 70 years. For adolescent subjects, the age range is 12 to 17 years.
- Subjects with atopic dermatitis covering ≥ 3% and < 40% of the body surface area and with an Investigator Global Assessment (IGA) of 2 or 3 (mild to moderate) at baseline. Scalp, palms and soles should be excluded from the BSA calculation to determine eligibility at baseline.
- NOTE: Subjects with mild disease (IGA =2) will be limited to approximately 25% of total enrollment.
- Minimum EASI score of 7 at baseline.
Show all 19Show fewer
- Females of childbearing potential and male subjects and 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 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:
- 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 a <1% rate of failure per year, as stated in the product label [Hatcher, 2007a]
- Oral Contraceptive, either combined or progestogen alone [Hatcher, 2007a] Injectable progestogen [Hatcher, 2007a]
- Contraceptive vaginal ring [Hatcher, 2007a]
- Percutaneous contraceptive patches [Hatcher, 2007a]
- 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 subjects understand how to properly use these methods of contraception.
- Non-child-bearing potential is defined as pre-menopausal females with a documented bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries) or hysterectomy; hysteroscopic sterilization; or postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40mlU is confirmatory. Documented verbal history from the subject is acceptable.
- Atopic Dermatitis present for at least 12 months according to the patient/care giver and stable disease for at least 1 month according to the patient/care giver.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- -
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- A positive Hepatitis B surface antigen or positive Hepatitis C antibody result at screening.
- A positive test for human immunodeficiency virus (HIV) antibody at screening.
- Screening alanine aminotransferase (ALT) ≥ 3x the upper limit of normal (ULN).
- Total bilirubin > 1.5x the upper limit of normal (ULN); total bilirubin > ULN and ≤ 1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%.
Show all 35Show fewer
- Corrected QT (QTc) interval >475 msec or >525 msec in the presence of bundle branch block.
- Subjects with a present illness of Kaposi's varicelliform eruption, scabies, molluscum contagiosum, impetigo, psoriasis, connective tissue disorder, or Netherton's syndrome, or any other disease which could have an effect on the pathological evaluation of atopic dermatitis.
- Use of any prohibited medication.
- Prohibited concomitant medications, therapy, etc. during the defined period are as follows. If a subject 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.
- From 6 months prior to the first application of study drugs to the completion of the follow-up examination or discontinuation:
- Biological products that might have significantly affected the evaluation of atopic dermatitis condition (e.g., TNF inhibitors, anti-IgE antibodies, anti-CD20 antibodies, anti-IL4 receptor)
- From 28 days prior to the first application of study drug until the completion of the Treatment Phase 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.)
- Over the counter or herbal medicines for atopic dermatitis (topical and oral preparations)
- Excessive sun exposure, tanning booth, other UV light source and phototherapy including PUVA therapy
- From 7 days prior to the first application of the study drugs to the completion of the Treatment Phase or discontinuation:
- Topical corticosteroids that were classified as low, medium, or high potency (fluocinonide, triamcinolone acetonide, desonide, hydrocortisone). Eye drop and nasal preparation are allowed.
- Tacrolimus and pimecrolimus cream and/or ointment
- Antihistamines/anti-allergics (oral, topical and injections): diphenhydramine, chlorpheniramine maleate, hydroxyzine).
- NOTE: The following antihistamines are allowed:
- Loratadine, fexofenadine hydrochloride, cetirizine hydrochloride
- From baseline throughout the treatment period
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive serum (screening) or urine (baseline) human chorionic gonadotropin test at screening or prior to dosing.
- 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 subject 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 with the exception of fully excised skin basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix.
- Subjects with active infection that required oral or intravenous administration of antibiotics, antifungal or antiviral agents within 7 days of Baseline/Day 0.
- Concurrent skin lesions in the treatment area or 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 subject.
- Subjects with advanced disease or abnormal laboratory test values that could affect the safety of the subject or the implementation of this study.
- Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities or laboratory abnormality that will affect the health of the subject or interfere with interpretation of the results.
- The subject has excessive sun exposure, is planning a trip to a sunny climate which 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.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States16 sites
Dermavant Investigator Site
Berlin, New Jersey, 08009
Dermavant Investigational Site
Dallas, Texas, 75230
Dermavant Investigator Site
Fremont, California, 94538
Dermavant Investigator Site
Hershey, Pennsylvania, 17022
Dermavant Investigator Site
Houston, Texas, 77004
Dermavant Investigator Site
Houston, Texas, 77030
Dermavant Investigator Site
Johnston, Rhode Island, 02919
Dermavant Investigator Site
Los Angeles, California, 90045
Dermavant Investigator Site
Louisville, Kentucky, 40202
Dermavant Investigator Site
Louisville, Kentucky, 40217
Dermavant Investigator Site
Norfolk, Virginia, 23502
Dermavant Investigator Site
Portland, Oregon, 97223
Dermavant Investigator Site
Portland, Oregon, 97239
Dermavant Investigator Site
San Antonio, Texas, 78213
Dermavant Investigator Site
San Diego, California, 92123
Dermavant Investigator Site
San Luis Obispo, California, 93405
Canada4 sites
Dermavant Investigational Site
Montreal, Quebec
Dermavant Investigator Site
Richmond, Ontario
Study site
Surrey, British Columbia
Dermavant Investigator Site
Waterloo, Ontario
About this study
This is a multi-center, randomized, vehicle-controlled, double-blind Phase 2 study in adults and adolescent subjects with mild to moderate atopic dermatitis.
Read the detailed description
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of the 0.2% BID and 0.5% concentrations of RVT-501 in patients with atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- RVT-501 0.2% ointment, 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 0.2% ointmentDrug
RVT-501 0.5% ointmentDrug
Vehicle ointmentOther
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| RVT-501 0.2% ointment | Experimental | RVT-501 0.2% ointment BID x 28 days (30 adults, 20 adolescents) Receives: Drug: RVT-501 0.2% ointment |
| RVT-501 0.5% ointment | Experimental | RVT-501 0.5% ointment BID x 28 days (30 adults, 20 adolescents) Receives: Drug: RVT-501 0.5% ointment |
| Vehicle ointment | Placebo comparator | Vehicle ointment BID x 28 days (30 adults, 20 adolescents) Receives: Other: Vehicle ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Laboratory values
Selected laboratory data will be summarized by the observed data and by the change from baseline (as appropriate) across time. Incidence of treatment emergent laboratory values that are considered clinically significantly abnormal will be summarized by treatment group.
Measured: 28 days
Vital signs
Vital signs will be measured in supine or semi-supine position after a 5 minute rest and will include systolic and diastolic blood pressure and pulse rate. Vital sign data will be listed by subject and summarized by treatment.
Measured: 28 days
ECGs
Single 12-lead ECGs will be obtained at Screening, Day 0, Day 7, Day 28 and during follow up 7-10 days-post-dose using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. ECG data will be listed by subject and summarized by treatment.
Measured: 28 Days
Plasma concentrations of RVT-501
PK samples will be collected pre-dose at week 1 for all subjects. At week 4, PK samples will be collected pre-dose and within 2-4 hours post-dose. RVT-501 will be measured in plasma by validated assay in all subjects to confirm exposure. These plasma concentrations will be listed separately for adults and adolescents by metabolite, subject, treatment, and time; and will be summarized by metabolite, treatment and time. The number of percent of subjects with measurable concentration at each time point and any time during the study will be provided.
Measured: 28 Days
Plasma concentrations of M11 metabolite
PK samples will be collected pre-dose at week 1 for all subjects. At week 4, PK samples will be collected pre-dose and within 2-4 hours post-dose. The M11 metabolite will be measured in plasma by validated assay in all subjects to confirm exposure. These plasma concentrations will be listed separately for adults and adolescents by metabolite, subject, treatment, and time; and will be summarized by metabolite, treatment and time. The number of percent of subjects with measurable concentration at each time point and any time during the study will be provided.
Measured: 28 Days
Secondary outcomes (3)
Efficacy - Investigators Global Assessment (IGA)
The Investigator's Global Assessment (IGA) of Disease Severity will be assessed at every on-site study visit. The IGA is a global assessment of the current state of the disease. It is a 5-point morphological assessment of overall disease severity All efficacy analyses will be performed based on the ITT population by treatment and age group. The total IGA scores, changes and percent changes from baseline will be summarized by treatment group and visit. The between treatment comparisons will be performed using an ANCOVA model similar to the model used for the EASI score
Measured: 28 days
Efficacy - Eczema Area and Severity Index (EASI)
The Eczema Area and Severity Index (EASI) will be assessed at every study visit. It quantifies the severity of a subject's atopic dermatitis based on both lesion severity and the percent of BSA affected. The total and regional EASI scores will be summarized for the actual, change from baseline and percent change from baseline. The between treatment comparisons of change and percent change from baseline will be performed by visit using an analysis of covariance model (ANCOVA)
Measured: 28 Days
Efficacy - Numeric Rating Scale (NRS) for Pruritus
NRS for Pruritus (Numerical Rating Scale) is a validated scale used to quickly assess pruritus severity. The total affected BSA and NRS for Pruritus will be analyzed similar to the EASI score. The patient reported symptoms and outcomes will be listed and summarized
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion3 Jul 2017
- Study completion3 Jul 2017
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
- 157 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, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950922
- Sponsor's protocol ID
- RVT-501-2001
- Status last verified
- Feb 2018
- First submitted
- 11 Oct 2016
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of RVT-501 in Adult and Adolescent Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02950922
- Acronym / sponsor ID
- RVT-501-2001
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Dermavant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- 3 Jul 2017 (actual)
- Study completion
- 3 Jul 2017 (actual)
- First posted
- 1 Nov 2016 (estimated)
- 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 adults and adolescent subjects with mild to moderate atopic dermatitis.
Detailed description
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of the 0.2% BID and 0.5% concentrations of RVT-501 in patients with atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RVT-501 0.2% ointment | Experimental | Drug: RVT-501 0.2% ointmentRVT-501 0.2% ointment BID x 28 days (30 adults, 20 adolescents) |
| RVT-501 0.5% ointment | Experimental | Drug: RVT-501 0.5% ointmentRVT-501 0.5% ointment BID x 28 days (30 adults, 20 adolescents) |
| Vehicle ointment | Placebo comparator | Other: Vehicle ointmentVehicle ointment BID x 28 days (30 adults, 20 adolescents) |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Males and females with confirmed diagnosis of atopic dermatitis by Hanifin and Rajka criteria (Appendix 4: Criteria for Atopic Dermatitis Diagnosis).
- For adult subjects, the age range is 18 to 70 years. For adolescent subjects, the age range is 12 to 17 years.
- Subjects with atopic dermatitis covering ≥ 3% and < 40% of the body surface area and with an Investigator Global Assessment (IGA) of 2 or 3 (mild to moderate) at baseline. Scalp, palms and soles should be excluded from the BSA calculation to determine eligibility at baseline.
- NOTE: Subjects with mild disease (IGA =2) will be limited to approximately 25% of total enrollment.
Key exclusion criteria (35 listed)
- -
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- A positive Hepatitis B surface antigen or positive Hepatitis C antibody result at screening.
- A positive test for human immunodeficiency virus (HIV) antibody at screening.
- Screening alanine aminotransferase (ALT) ≥ 3x the upper limit of normal (ULN).
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 0.2% ointment | Drug | RVT-501 0.2% ointment |
| RVT-501 0.5% ointment | Drug | RVT-501 0.5% ointment |
| Vehicle ointmentPlacebo comparator | Other | Vehicle ointment |
Primary outcome
Frequency and severity of adverse events (local and systemic)
Time frame: 28 days
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
Laboratory values
Time frame: 28 days
Selected laboratory data will be summarized by the observed data and by the change from baseline (as appropriate) across time. Incidence of treatment emergent laboratory values that are considered clinically significantly abnormal will be summarized by treatment group.
Vital signs
Time frame: 28 days
Vital signs will be measured in supine or semi-supine position after a 5 minute rest and will include systolic and diastolic blood pressure and pulse rate. Vital sign data will be listed by subject and summarized by treatment.
ECGs
Time frame: 28 Days
Single 12-lead ECGs will be obtained at Screening, Day 0, Day 7, Day 28 and during follow up 7-10 days-post-dose using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. ECG data will be listed by subject and summarized by treatment.
Plasma concentrations of RVT-501
Time frame: 28 Days
PK samples will be collected pre-dose at week 1 for all subjects. At week 4, PK samples will be collected pre-dose and within 2-4 hours post-dose. RVT-501 will be measured in plasma by validated assay in all subjects to confirm exposure. These plasma concentrations will be listed separately for adults and adolescents by metabolite, subject, treatment, and time; and will be summarized by metabolite, treatment and time. The number of percent of subjects with measurable concentration at each time point and any time during the study will be provided.
Plasma concentrations of M11 metabolite
Time frame: 28 Days
PK samples will be collected pre-dose at week 1 for all subjects. At week 4, PK samples will be collected pre-dose and within 2-4 hours post-dose. The M11 metabolite will be measured in plasma by validated assay in all subjects to confirm exposure. These plasma concentrations will be listed separately for adults and adolescents by metabolite, subject, treatment, and time; and will be summarized by metabolite, treatment and time. The number of percent of subjects with measurable concentration at each time point and any time during the study will be provided.
3 secondary outcomes
Efficacy - Investigators Global Assessment (IGA)
Time frame: 28 days
Efficacy - Eczema Area and Severity Index (EASI)
Time frame: 28 Days
Efficacy - Numeric Rating Scale (NRS) for Pruritus
Time frame: 28 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 6 Aug 2018.
- 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, Chief Medical Officer
20 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 0.2% ointment and RVT-501 0.5% ointment in people with Atopic Dermatitis, run by Dermavant Sciences GmbH at 20 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 35 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 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
Frequency and severity of adverse events (local and systemic) (time frame: 28 days). The study lists 6 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 6 Aug 2018.