ClinicalTrials.gg
CompletedNCT04103060Updated Nov 24, 2020

Safety and Tolerability Study of Cerdulatinib Gel, 0.37% in Adults With Vitiligo

A Phase 2 interventional study of Cerdulatinib 0.37% gel and Vehicle gel in Vitiligo, sponsored by Dermavant Sciences GmbH. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-24.

Sponsored by Dermavant Sciences GmbH (part of Organon & Co.) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2020, 6 years ago, and no results have been posted to the registry.

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Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 80 studies in Vitiligo with a site in United States — 14 open to participants now, 24 under way, 7 of them phase 3. Vitiligo · United States.

Enrollment
36th of 68
33 · median 37
Started
2019
with 3 others
Phase 2
31 of 80
6 open now
Registered
35th of 80
by date

Among the 80 studies in Vitiligo with a site in United States, this one is the 36th largest by enrollment of the 68 interventional ones that give a count, is one of 4 that started in 2019, is one of 31 in phase 2, and was the 35th registered.

Vitiligo

343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.

Browse Vitiligo studies →

Open to participants now

14 of the 80 studies in Vitiligo with a site in United States are open now. Recruiting first, the newest first:

9 more — sign in →

All 14 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 48 Vitiligo studies recruiting now, 13 (27%) set no upper age limit and 29 (60%) stop at 75 or younger; 18 take children under 18; 8 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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

03

Conditions studied

  • Vitiligo

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 guidance throughout the study
  • Capable of giving

Exclusion criteria

Exclusion Criteria:

  • 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 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;
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Cerdulatinib 0.37% gel

    Cerdulatinib 0.37% gel applied topically twice daily

    Drug: Cerdulatinib 0.37% gel

  • Placebo comparator
    Vehicle gel

    Vehicle gel applied topically twice daily

    Drug: Vehicle gel

Interventions

  • Cerdulatinib 0.37% gel applied topically twice daily for 6 weeks

    Also known as: DMVT-502

  • DrugVehicle gel

    Vehicle gel applied topically twice daily for 6 weeks

06

What researchers measure

Primary outcomes

  1. Vital signs

    Body temperature, blood pressure, pulse (heart rate), and breathing rate (respiratory rate)

    Time frame: Baseline through Week 7

  2. Laboratory Values

    Clinically significant abnormal lab values

    Time frame: Baseline through Week 7

  3. Adverse Events

    Frequency, severity, and duration of adverse events

    Time frame: Baseline through Week 7

  4. Local Tolerability Scale Score

    Assessment of local site investigational product administration

    Time frame: Baseline, Week 2, Week 4, Week 6, and Week 7

Secondary outcomes

  1. Concentration of cerdulatinib

    Plasma concentration

    Time frame: Days 1, 15, 29 and 43

  2. Blister fluid biomarker concentration

    From active treated lesions and untreated nonlesional skin

    Time frame: Baseline and Week 6

07

Study locations

2 sites
  • Dermavant Investigational Site
    Irvine, California 92617, United States
  • Dermavant Investigational Site
    Worcester, Massachusetts 01605, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2019 to primary completion in Nov 2020, 13 months.

Of 44 phase 2 interventional studies under Vitiligo, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 26. This study's 13 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2019
First posted
Sep 25, 2019
StartActual
Sep 27, 2019
Primary completionActual
Nov 3, 2020
CompletionActual
Nov 3, 2020
Last update
Nov 24, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04103060
Responsible party
Sponsor
First posted
Sep 25, 2019
Start date
Sep 27, 2019
Primary completion
Nov 3, 2020
Completion
Nov 3, 2020
Last update
Nov 24, 2020

Study contacts

Michael McLaughlin
study director · Dermavant Sciences GmbH

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Cerdulatinib

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