Primary:To evaluate the efficacy of ruxolitinib cream in participants with vitiligo.Secondary:To further assess the efficacy of ruxolitinib cream.To evaluate the safety and tolerability of ruxolitinib cream.To evaluate the ruxolitinib PK in plasma…
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of participants achieving F-VASI75 at Week 24.
Secondary outcome
• Percentage change from baseline in F-BSA at Week 24.
• Proportion of participants achieving F-VASI50 at Week 24.
• Proportion of participants achieving F-VASI75 at Week 52.
• Proportion of participants achieving F-VASI90 at Week 24.
• Proportion of participants achieving F-VASI90 at Week 52.
• Proportion of participants achieving T-VASI50 at Week 24.
• Proportion of participants achieving T-VASI50 at Week 52.
• Proportion of participants achieving T-VASI75 at Week 52.
• Proportion of participants achieving a VNS of *4 - A lot less noticeable* or
*5 - No longer noticeable* at Week 24.
• The frequency, duration, and severity of AEs; physical examinations; vital
signs; and laboratory data for hematology and serum chemistry.
• Proportion of participants achieving F-VASI25/50/75/90 during the treatment
period (double-blind and treatment extension periods).
• Proportion of participants achieving T-VASI25/50/75/90 during the treatment
period (double-blind and treatment extension periods).
• Proportion of participants in each category of VNS during the treatment
period (double-blind and treatment extension periods).
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 randomized, vehicle-controlled study in adolescent and adult
participants (age >= 12 years) with non-segmental vitiligo who have depigmented
area including >= 0.5% BSA on the face, >= 0.5 F-VASI, >= 3% BSA on nonfacial
areas, and >= 3 T-VASI. Total body involved vitiligo area (facial and nonfacial)
should not exceed 10% BSA. Approximately 300 participants will be randomized
2:1 to receive initial study treatment (ruxolitinib cream 1.5% BID:vehicle;
applied to depigmented vitiligo areas on the face and body up to 10% total BSA)
for 24 weeks
After completion of the Week 24 assessments, participants will be offered the
opportunity to receive an additional 28 weeks of treatment extension with
ruxolitinib cream 1.5% BID. To be eligible for the treatment extension,
participants must have completed the baseline and Week 24 visit assessments, be
compliant with study procedures, and not have any safety issues. The total
treated area should not exceed 10% BSA (facial and nonfacial).
Participants who successfully complete the 52-week treatment in this study may
be eligible to participate in a separate extension study to evaluate durability
of effect and maintenance regimens.
Study objective
Primary:
To evaluate the efficacy of ruxolitinib cream in participants with vitiligo.
Secondary:
To further assess the efficacy of ruxolitinib cream.
To evaluate the safety and tolerability of ruxolitinib cream.
To evaluate the ruxolitinib PK in plasma after treatment of ruxolitinib cream.
Study design
Randomized, double-blind, vehicle-controlled, with a treatment extension
period.
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-Off 1801
Wilmington 19803
US
Augustine Cut-Off 1801
Wilmington 19803
US
Listed location countries
Age
Inclusion criteria
- Adolescents and adults aged >= 12 years.
- Participants with a clinical diagnosis of non-segmental vitiligo with
depigmented area including >= 0.5% BSA on the face, >= 0.5 F-VASI, >= 3% BSA on
nonfacial areas, >= 3 T-VASI, and total body vitiligo area (facial and
non-facial) not exceeding 10% BSA.
- Participants who agree to discontinue all agents used to treat vitiligo from
screening through the final safety follow-up visit. Over-the-counter
preparations deemed acceptable by the investigator and camouflage makeups are
permitted.
Exclusion criteria
- Participants who have no pigmented hair within any of the vitiligo areas on
the face.
- Other forms of vitiligo (eg, segmental) or other differential diagnosis of
vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis
alba, leprosy, postinflammatory hypopigmentation, progressive macule
hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
- Participants who have used depigmentation treatments (eg, monobenzone) for
past treatment of vitiligo or other pigmented areas.
Note: Prior use of hydroquinone is not prohibited (as it is a bleaching agent,
not a depigmentation treatment).
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 | EUCTR2019-000847-28-NL |
| ClinicalTrials.gov | NCT04057573 |
| CCMO | NL70922.018.20 |