Atopic DermatitisPhase 1NCT03415282
Open-Label Study of RVT-501 Topical Ointment in Pediatric Patients With Atopic Dermatitis
A Phase 1 study testing RVT-501 0.5% topical ointment in people with Atopic Dermatitis, run by Dermavant Sciences GmbH at 12 sites in United States.
Trial summary
This is a multicenter, open-label Phase 1b study in pediatric patients age 2-11 years old with extensive atopic dermatitis. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- RVT-501 0.5% topical ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 12 sitesUnited States
- Study dates
- 5 Feb 2018to 7 Aug 2018
- 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 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female pediatric patients aged 2 to 11 with confirmed diagnosis of atopic dermatitis by Hanifin and Rajka criteria.
- Patients with atopic dermatitis covering > 25% of the body surface area and with an Investigator Global Assessment of disease severity of 2 or greater at baseline.
- Minimum body weight of 10 kg.
- 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 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 a <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.
- Nonchildbearing potential is defined as premenarchal or premenopausal 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 use one of the birth control methods listed above if they start engaging in sexual activity that could lead to pregnancy during the study.
- Female patients 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 or caregiver.
- Patient or patient's parent(s)/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.
- From 6 months prior to the first application of study drugs to the completion of the Follow-up visit or discontinuation:
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- 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 drops and nasal preparations are allowed. Inhaled preparations are allowed if used for a stable condition and at 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 (e.g., 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.
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Dermavant Investigational Site
Anniston, Alabama, 36207
Dermavant Investigational Site
Arlington, Texas, 76011
Dermavant Investigational Site
Indianapolis, Indiana, 46256
Dermavant Investigational Site
Irvine, California, 92617
Dermavant Investigational Site
Jacksonville, Florida, 32256
Dermavant Investigational Site
Miami, Florida, 33172
Dermavant Investigational Site
Miami, Florida, 33174
Dermavant Investigational Site
Raleigh, North Carolina, 27612
Dermavant Investigational Site
Richmond, Virginia, 23220
Dermavant Investigational Site
San Antonio, Texas, 78213
Dermavant Investigational Site
San Antonio, Texas, 78229
Dermavant Investigational Site
Stockbridge, Georgia, 30281
About this study
Official title: Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RVT-501 Topical Ointment in Pediatric Patients With Atopic Dermatitis
This is a multicenter, open-label Phase 1b study in pediatric patients age 2-11 years old with extensive atopic dermatitis.
Read the detailed description
The purpose of this multicenter, open-label study is to evaluate the safety, tolerability, and pharmacokinetics of RVT-501 0.5% topical ointment administered twice daily (BID) for 4 weeks in pediatric patients age 2-11 years of age with extensive atopic dermatitis. The efficacy of RVT-501 will also be evaluated as a secondary objective in these patients. The study will consist of three phases: Screening (up to 30 days), Treatment Phase (28 days), and Follow-up (7-10 days).
- Conditions
- Atopic Dermatitis
- Being tested
- RVT-501 0.5% topical 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% topical ointmentDrug
RVT-501 0.5% topical ointment twice daily (BID) for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Open-label treatment arm | Experimental | Open-label treatment arm - patients will receive RVT-501 0.5% twice daily (BID) for 4 weeks. Receives: Drug: RVT-501 0.5% topical 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
Plasma concentrations of RVT-501
PK samples will be collected at week 1 pre-dose, 2-4 hours post-dose, and 6-8 hours post dose for all subjects. At week PK samples will be collected pre-dose. RVT-501 will be measured in plasma by validated assay in all subjects to confirm exposure. These plasma concentrations will be listed by metabolite, subject, treatment, and time; and will be summarized by analyte and time. If data permit, RVT-501 and M11 concentrations will be summarized descriptively at each collection time point.
Measured: 28 days
Plasma concentrations of M11 metabolite
PK samples will be collected at week 1 pre-dose, 2-4 hours post-dose, and 6-8 hours post dose for all subjects. At week 4 PK samples will be collected pre-dose. The M11 metabolite will be measured in plasma by validated assay in all subjects to confirm exposure. These plasma concentrations will be listed by metabolite, subject, treatment, and time; and will be summarized by metabolite, treatment and time. If data permit, RVT-501 and M11 concentrations will be summarized descriptively at each collection time point.
Measured: 28 days
Secondary outcomes (9)
Efficacy - Investigators Global Assessment (IGA)
Efficacy will be evaluated as the change from Baseline in IGA score.
Measured: 28 days
Efficacy - 2-point improvement in IGA
Efficacy will be evaluated by the proportion of patients who achieve an IGA of 0 or 1 with at least a 2-point improvement from Basline
Measured: 28 days
Efficacy - IGA of 0 or 1 at study end
Efficacy will be evaluated by the proportion of patients who achieve an IGA of 0 or 1 at Week 4.
Measured: 28 days
Efficacy - Eczema Area and Severity Index (EASI) score
Efficacy will be evaluated as the change from Baseline in EASI score.
Measured: 28 days
Efficacy - EASI-50
Efficacy will be evaluated by the proportion of patients who achieve at least a 50% reduction from Baseline EASI (EASI-50) at Week 4.
Measured: 28 days
Efficacy - Peak Pruritus Numeric Rating Scale (NRS)
Efficacy will be evaluated as the change from Baseline in Peak Pruritus as measured with the NRS at Week 4.
Measured: 28 days
Efficacy - Body Surface Area (BSA)
Efficacy will be evaluated as the change from Baseline in BSA affected by disease at Week 4.
Measured: 28 days
Efficacy - Patient/caregiver reported itch severity (local)
The patient or their caregiver will assess itch severity at the application site and efficacy will be determined as a change from Baseline.
Measured: 28 days
Efficacy - Patient/caregiver reported itch severity (global)
The patient or their caregiver will assess global itch severity and efficacy will be determined as change from Baseline.
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 posted30 Jan 2018
- Study start5 Feb 2018
- Primary completion24 Jul 2018 (estimated)
- Study completion7 Aug 2018 (estimated)
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
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
- NCT03415282
- Sponsor's protocol ID
- RVT-501-2007
- Status last verified
- May 2018
- First submitted
- 23 Jan 2018
- Last updated
- 11 May 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 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RVT-501 Topical Ointment in Pediatric Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03415282
- Acronym / sponsor ID
- RVT-501-2007
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dermavant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 24 Jul 2018 (estimated)
- Study completion
- 7 Aug 2018 (estimated)
- First posted
- 30 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 multicenter, open-label Phase 1b study in pediatric patients age 2-11 years old with extensive atopic dermatitis.
Detailed description
The purpose of this multicenter, open-label study is to evaluate the safety, tolerability, and pharmacokinetics of RVT-501 0.5% topical ointment administered twice daily (BID) for 4 weeks in pediatric patients age 2-11 years of age with extensive atopic dermatitis. The efficacy of RVT-501 will also be evaluated as a secondary objective in these patients. The study will consist of three phases: Screening (up to 30 days), Treatment Phase (28 days), and Follow-up (7-10 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label treatment arm | Experimental | Drug: RVT-501 0.5% topical ointmentOpen-label treatment arm - patients will receive RVT-501 0.5% twice daily (BID) for 4 weeks. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- Male and female pediatric patients aged 2 to 11 with confirmed diagnosis of atopic dermatitis by Hanifin and Rajka criteria.
- Patients with atopic dermatitis covering > 25% of the body surface area and with an Investigator Global Assessment of disease severity of 2 or greater at baseline.
- Minimum body weight of 10 kg.
- 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 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 (33 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. 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.
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% topical ointmentRVT-501 0.5% topical ointment twice daily (BID) for 4 weeks. | Drug | Open-label treatment arm |
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.
Plasma concentrations of RVT-501
Time frame: 28 days
PK samples will be collected at week 1 pre-dose, 2-4 hours post-dose, and 6-8 hours post dose for all subjects. At week PK samples will be collected pre-dose. RVT-501 will be measured in plasma by validated assay in all subjects to confirm exposure. These plasma concentrations will be listed by metabolite, subject, treatment, and time; and will be summarized by analyte and time. If data permit, RVT-501 and M11 concentrations will be summarized descriptively at each collection time point.
Plasma concentrations of M11 metabolite
Time frame: 28 days
PK samples will be collected at week 1 pre-dose, 2-4 hours post-dose, and 6-8 hours post dose for all subjects. At week 4 PK samples will be collected pre-dose. The M11 metabolite will be measured in plasma by validated assay in all subjects to confirm exposure. These plasma concentrations will be listed by metabolite, subject, treatment, and time; and will be summarized by metabolite, treatment and time. If data permit, RVT-501 and M11 concentrations will be summarized descriptively at each collection time point.
9 secondary outcomes
Efficacy - Investigators Global Assessment (IGA)
Time frame: 28 days
Efficacy - 2-point improvement in IGA
Time frame: 28 days
Efficacy - IGA of 0 or 1 at study end
Time frame: 28 days
Efficacy - Eczema Area and Severity Index (EASI) score
Time frame: 28 days
Efficacy - EASI-50
Time frame: 28 days
Efficacy - Peak Pruritus Numeric Rating Scale (NRS)
Time frame: 28 days
Efficacy - Body Surface Area (BSA)
Time frame: 28 days
Efficacy - Patient/caregiver reported itch severity (local)
Time frame: 28 days
Efficacy - Patient/caregiver reported itch severity (global)
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Official Website for Dermavant SciencesLink 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.
12 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 RVT-501 0.5% topical ointment in people with Atopic Dermatitis, run by Dermavant Sciences GmbH at 12 sites in United States.
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 33 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: status not confirmed, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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 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?
Results are not available in the source record.
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 5 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 May 2018.