A Randomized, Double-Blind, Dose-Ranging Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

  • STATUS
    Recruiting
  • sponsor
    Incyte Corporation
Updated on 15 December 2020
DERMATOLOGY SPECIALISTS, INC (93.1 mi away) Contact
+14 other location
vitiligo

Summary

A Randomized, Double-Blind, Dose-Ranging Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

Description

The purpose of this study is to evaluate the efficacy of 24 weeks of treatment with INCB018424 cream in subjects with vitiligo.

For more information, please contact Incyte Corporation at 1.855.463.3463

Details
Condition Vitiligo
Clinical Study IdentifierTX151817
SponsorIncyte Corporation
Last Modified on15 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female subjects aged 18 to 75 years, inclusive
Subjects with a clinical diagnosis of vitiligo
Subjects with vitiligo with depigmented areas including
at least 0.5% of the total BSA on the face (0.5% BSA is approximately equal to the area of the subject's palm [without digits]) AND
at least 3% of the total BSA on nonfacial areas (3% BSA is approximately equal to the area of 3 of the subject's handprints [palm plus 5 digits])

Exclusion Criteria

Conditions at baseline that would interfere with evaluation of vitiligo
Subjects who are receiving any kind of phototherapy, including tanning beds
Subjects with other dermatologic disease besides vitiligo whose presence or treatments could complicate the assessment of repigmentation
Subjects who have used skin bleaching treatments for past treatment of vitiligo or other pigmented areas
Subjects who have received any of the following treatments within the minimum specified timeframes
Use of any biologic, investigational, or experimental therapy or procedure for vitiligo within 12 weeks or 5 half-lives (whichever is longer) of screening. Investigational biologics should be discussed with the sponsor to determine if a longer period of discontinuation is required
Use of laser or light-based vitiligo treatments, including tanning beds, within 8 weeks of screening
Use of immunomodulating oral or systemic medications (eg, corticosteroids, methotrexate, cyclosporine) or topical treatments that may affect vitiligo within 4 weeks of screening
Subjects with a clinically significant abnormal TSH or free T4 at screening as determined by the investigator
Subjects with cytopenias at screening
Subjects with severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase or aspartate aminotransferase ≥ 1.5 × upper limit of normal on repeated assessment
Subjects with impaired renal function with estimated creatinine clearance less than 60 mL/min
Positive serology test results for HIV, for hepatitis B surface antigen or core antibody, or for hepatitis C virus antibody with detectable RNA at screening
Subjects taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit
Subjects who have previously received JAK inhibitor therapy, systemic or topical
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note