Primary Objective:To evaluate the duration of clinical response of ruxolitinib cream in participants with vitiligo.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For participants who are randomized in Cohort A: * Time to relapse (defined as
< F-VASI75)
Secondary outcome
For participants who are randomized in Cohort A: * Time to maintain * F-VASI90
response
and:
* Proportion of participants who achieve F-VASI50/75/90 during the extension
treatment period.
* Actual measurements, change, and percentage change from baseline in F-VASI.
* Proportion of participants who achieve T-VASI50/75/90 during the extension
treatment period.
* Actual measurements, change, and percentage change from baseline in T-VASI.
* Actual measurements, change, and percentage change from baseline in F-BSA.
* Actual measurements, change, and percentage change from baseline in T-BSA.
* Proportion of participants achieving a VNS of *4 * A lot less noticeable* or
*5 * No longer noticeable* during the extension treatment period
Background summary
Ruxolitinib cream is a topical formulation of ruxolitinib phosphate under
development for the treatment of participants with AD, AA,plaque psoriasis, and
vitiligo. Ruxolitinib phosphate is an inhibitor of the JAK family of protein
TYKs. Inflammatory cytokines are strongly implicated in the pathogenesis of
several dermatologic diseases. Because JAKs serve to translate extracellular
signals from a number of relevant cytokines and growth factors upregulated in
inflammatory diseases such as AD, AA, plaque psoriasis,and vitiligo, JAK
inhibitors represent potential therapeutic agents for these disease states.
This is a Phase 3, double-blind, vehicle-controlled, randomized withdrawal and
treatment extension study that will enroll eligible participants who have
completed either Study INCB 18424-307, conducted at the AMC (NL70922.018.20)
Study objective
Primary Objective:
To evaluate the duration of clinical response of ruxolitinib cream in
participants with vitiligo.
Study design
Key Secondary Objective:
To evaluate the duration of clinical response of ruxolitinib cream in
participants with vitiligo
Other Secondary Objective:
To further evaluate the efficacy of ruxolitinib cream
Intervention
ruxolitinib cream 1.5% /:vehicle
Study burden and risks
Burden and risks: - Possible side effects from the treatment (side effects are
described in Appendix D of the ICF) - Discomfort, soreness, bruising: in rare
cases infection, light headedness/fainting from blood drawing - Rash or
irritation from ECG sticky pads. - Commitment to follow instructions associated
with the study treatment and visits schedule
Currently, there are no approved therapies for vitiligo, and treatments are
empirical and directed by the available clinical guidelines. Current therapies
often do not lead to satisfactory response, and there are limitations and
safety concerns with long-term use of some therapies, including topical or oral
corticosteroids and calcineurin inhibitors. Given the psychosocial burden and
stigma that has been reported in this disease, patients with vitiligo warrant
access to new studies.
Augustine Cut-Of 1891
Wilmington 19803
US
Augustine Cut-Of 1891
Wilmington 19803
US
Listed location countries
Age
Inclusion criteria
1. Currently enrolled and receiving treatment in INCB 18424-306 or INCB
18424-307 studies evaluating ruxolitinib cream in participants with vitiligo.
2. Currently tolerating ruxolitinib cream in the parent study and no safety
concerns per investigators judgment.
3. Has demonstrated compliance, as assessed by the investigator, with the
parent study protocol requirements
Exclusion criteria
1. Has been permanently discontinued from study treatment in the parent study
for any reason.
2. Participants with an uncontrolled intercurrent illness or any concurrent
condition that, in the investigator's opinion, would jeopardize the safety of
the participant or compliance with the Protocol. 3. Pregnant or breastfeeding
woman
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-000987-53-NL |
| CCMO | NL75444.018.20 |