Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants with Vitiligo
- Conditions
- VitiligoMedDRA version: 21.1Level: PTClassification code 10047642Term: VitiligoSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2019-000846-37-DE
- Lead Sponsor
- Incyte Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
1. Adolescents and adults aged = 12 years.
2. 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 nonfacial) not exceeding 10% BSA.
3. 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.
4. Male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation with the exception of the following:
a. Females of non-childbearing potential (ie, or surgically sterile with a hysterectomy and/or bilateral oophorectomy OR postmenopausal, = 12 months of amenorrhea without an alternative medical cause).
b. Prepubescent adolescents.
Note: Information about specific types of acceptable contraceptive measures and duration of contraceptive use are provided in the protocol.
5. For adult participant, ability to comprehend and willingness to sign an ICF, for adolescent participant written informed consent of the parent(s) or legal guardian and written assent from the adolescent participant.
Note: Adolescents, who during the course of the study become legal adults, will be asked for their consent to continue the study, and in the event of lack thereof, will be discontinued from further participation.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 30
1. Participants who have no pigmented hair within any of the vitiligo areas on the face.
2. 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).
3. 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).
4. Participants with concurrent conditions and history of other diseases:
a. Any other skin disease that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
b. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox) within 1 week before baseline.
c. Conditions at baseline that would interfere with evaluation of vitiligo.
d. Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Examples include but are not limited to the following:
- Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy or uncontrolled hypertension (blood pressure > 150/90 mmHg) unless approved by the medical monitor/sponsor.
- History of thrombosis, including deep venous thrombosis and pulmonary embolism.
- Participants with concurrent malignant disease or a history of that in the 5 years preceding the baseline visit except for adequately treated nonmetastatic malignancies.
- Current and/or history of liver disease, including known hepatitis B or C, with hepatic or biliary abnormalities.
- Current and/or history of tuberculosis.
-History of alcoholism or drug addiction within 1 year before screening or current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the administration schedule and study assessments.
- Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
5. Participants using any of the following treatments within the indicated washout period before baseline:
a. 1 week: Topical drugs when used on the vitiligo areas, for example, corticosteroids, calcineurin, and phosphodiesterase type 4 inhibitors or retinoids.
b. 4 weeks:
- Melanocyte-stimulating agents (eg, afamelanotide).
- Immunomodulating systemic medications (eg, corticosteroids, methotrexate, cyclosporine).
- Any other systemic therapies that could increase the skin sensitivity to UV/visible light or impact skin pigmentation, for example, tetracyclines, metoxypsoralens.
- Received live vaccine.
Note: Live vaccine is prohibited during the course of the study and within 4 weeks after the EOT visit.
c. 8 weeks: Laser or any kind of phototherapy, including tanning bed or intentional UV exposure.
d. 5 half-lives or 12 wee
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of ruxolitinib cream in participants with vitiligo.;Secondary Objective: Key secondary:<br>To further assess the efficacy of ruxolitinib cream<br>Secondary:<br>To evaluate the safety and tolerability of ruxolitinib cream.<br>To evaluate the ruxolitinib PK in plasma after treatment of ruxolitinib cream.;Primary end point(s): Proportion of participants achieving F-VASI75 at Week 24.;Timepoint(s) of evaluation of this end point: 24 weeks
- Secondary Outcome Measures
Name Time Method