VitiligoPhase 2NCT04103060
Safety and Tolerability Study of Cerdulatinib Gel, 0.37% in Adults With Vitiligo
A Phase 2 study testing Cerdulatinib 0.37% gel in people with Vitiligo, run by Dermavant Sciences GmbH at 2 sites in United States.
Trial summary
This is a phase 2a, randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, and systemic exposure of cerdulatinib gel, 0.37% in adults with vitiligo Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Cerdulatinib 0.37% gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Sep 2019to 3 Nov 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects age 18 and older with a confirmed clinical diagnosis of vitiligo for at least 3 months, including ≥0.5% to ≤30% BSA involvement.
- Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study
- Capable of giving informed consent
Who cannot join
- Diagnosis of segmental vitiligo
- Subjects with concurrent conditions or history of other diseases (e.g., current or chronic history of liver disease) that could affect the safety of the subject or the implementation of this study
- Use of any prohibited medication within the indicated period before the first dose of study drug
- Pregnant or lactating females
- Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 8 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's vitiligo
- The subject has received an investigational product within the following time period prior to the first dosing day: 4 weeks or 5 half-lives (whichever is longer).
- Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular (CV) system abnormalities or laboratory test value abnormality that will affect the health of the subject or interfere with interpretation of the results
- History of sensitivity to the study drug, or components thereof or a history of drug or other allergy that contraindicates the subject's participation in the study;
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dermavant Investigational Site
Irvine, California, 92617
Dermavant Investigational Site
Worcester, Massachusetts, 01605
About this study
Official title: A Phase 2a, Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Safety, Tolerability, and Systemic Exposure of Cerdulatinib Gel, 0.37% in Adults With Vitiligo
This is a phase 2a, randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, and systemic exposure of cerdulatinib gel, 0.37% in adults with vitiligo
- Conditions
- Vitiligo
- Being tested
- Cerdulatinib 0.37% gel, Vehicle gel
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerdulatinib 0.37% gelDrug
Also called DMVT-502
Cerdulatinib 0.37% gel applied topically twice daily for 6 weeks
Vehicle gelDrug
Vehicle gel applied topically twice daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cerdulatinib 0.37% gel | Experimental | Cerdulatinib 0.37% gel applied topically twice daily Receives: Drug: Cerdulatinib 0.37% gel |
| Vehicle gel | Placebo comparator | Vehicle gel applied topically twice daily Receives: Drug: Vehicle gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs
Body temperature, blood pressure, pulse (heart rate), and breathing rate (respiratory rate)
Measured: Baseline through Week 7
Laboratory Values
Clinically significant abnormal lab values
Measured: Baseline through Week 7
Adverse Events
Frequency, severity, and duration of adverse events
Measured: Baseline through Week 7
Local Tolerability Scale Score
Assessment of local site investigational product administration
Measured: Baseline, Week 2, Week 4, Week 6, and Week 7
Secondary outcomes (2)
Concentration of cerdulatinib
Plasma concentration
Measured: Days 1, 15, 29 and 43
Blister fluid biomarker concentration
From active treated lesions and untreated nonlesional skin
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start27 Sep 2019
- Primary completion3 Nov 2020
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermavant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael McLaughlin, Study director, Dermavant Sciences GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103060
- Sponsor's protocol ID
- DMVT-502-2101
- Status last verified
- Nov 2020
- First submitted
- 18 Sep 2019
- Last updated
- 24 Nov 2020
- Results posted
- No
- 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 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Safety, Tolerability, and Systemic Exposure of Cerdulatinib Gel, 0.37% in Adults With Vitiligo
- ClinicalTrials.gov ID
- NCT04103060
- Acronym / sponsor ID
- DMVT-502-2101
- Conditions
- Vitiligo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Dermavant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2a, randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, and systemic exposure of cerdulatinib gel, 0.37% in adults with vitiligo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerdulatinib 0.37% gel | Experimental | Drug: Cerdulatinib 0.37% gelCerdulatinib 0.37% gel applied topically twice daily |
| Vehicle gel | Placebo comparator | Drug: Vehicle gelVehicle gel applied topically twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects age 18 and older with a confirmed clinical diagnosis of vitiligo for at least 3 months, including ≥0.5% to ≤30% BSA involvement.
- Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study
- Capable of giving informed consent
Key exclusion criteria (8 listed)
- Diagnosis of segmental vitiligo
- Subjects with concurrent conditions or history of other diseases (e.g., current or chronic history of liver disease) that could affect the safety of the subject or the implementation of this study
- Use of any prohibited medication within the indicated period before the first dose of study drug
- Pregnant or lactating females
- Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 8 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's vitiligo
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 |
|---|---|---|
| Cerdulatinib 0.37% gelAlso: DMVT-502Cerdulatinib 0.37% gel applied topically twice daily for 6 weeks | Drug | Cerdulatinib 0.37% gel |
| Vehicle gelVehicle gel applied topically twice daily for 6 weeks | Drug | Vehicle gel |
Primary outcome
Vital signs
Time frame: Baseline through Week 7
Body temperature, blood pressure, pulse (heart rate), and breathing rate (respiratory rate)
Laboratory Values
Time frame: Baseline through Week 7
Clinically significant abnormal lab values
Adverse Events
Time frame: Baseline through Week 7
Frequency, severity, and duration of adverse events
Local Tolerability Scale Score
Time frame: Baseline, Week 2, Week 4, Week 6, and Week 7
Assessment of local site investigational product administration
2 secondary outcomes
Concentration of cerdulatinib
Time frame: Days 1, 15, 29 and 43
Blister fluid biomarker concentration
Time frame: Baseline and Week 6
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 24 Nov 2020.
- 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.
Michael McLaughlin study director
Dermavant Sciences GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cerdulatinib 0.37% gel in people with Vitiligo, run by Dermavant Sciences GmbH at 2 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 3 inclusion and 8 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 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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. 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?
Vital signs (time frame: Baseline through Week 7). 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 24 Nov 2020.