Evaluating Ruxolitinib Cream for Children with Nonsegmental Vitiligo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of ruxolitinib cream in pediatric patients diagnosed with nonsegmental vitiligo. Participants must have specific criteria regarding the extent of their vitiligo and agree to discontinue other treatments during the study. The trial involves applying ruxolitinib cream compared to a vehicle cream to assess its effectiveness in repigmenting the skin. The study aims to provide insights into a potential new treatment option for this skin condition in children.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 2% BSA on nonfacial areas, ≥ 2 T-VASI.
* Total body vitiligo area does not exceed 10% BSA.
* Pigmented hair within some of the areas of vitiligo on the face.
* Must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit.
* For sexually active participants (except participants who are prepubescent) willingness to avoid pregnancy or fathering a child from screening through 30 days after the last application of study cream.

Exclusion Criteria:

* Diagnosis of other forms of vitiligo (eg, segmental).
* 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).
* Any other skin disease that, in the opinion of the investigator, would interfere with the study drug application or study assessments.
* Prior or current use of depigmentation treatments (eg, monobenzone).
* 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 application of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
* Use of protocol-defined treatments within the indicated washout period before baseline.
* History of treatment failure with any systemic or topical JAK inhibitor (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, and upadacitinib) for vitiligo or any other inflammatory condition.
* Protocol-defined clinically significant abnormal laboratory values at screening.
* Pregnant or lactating participants or those considering pregnancy during the period of their study participation.
* In the opinion of the investigator, unable or unlikely to comply with the application schedule and study evaluations.
* Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study.
* Employees of the sponsor or investigator or are otherwise dependents of them.
* Known allergy or reaction to any component of the study cream formulation.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Where it's running

• University of Alabama At Birmingham-School of Medicine
  Birmingham, Alabama, United States Recruiting
• Saguaro Dermatology
  Phoenix, Arizona, United States Recruiting
• Phoenix Children'S Hospital
  Phoenix, Arizona, United States Recruiting
• Omni Dermatology
  Phoenix, Arizona, United States Recruiting
• Banner - University Medicine Multispecialty Services Clinic
  Tucson, Arizona, United States Recruiting
• Premier Dermatology Clinical Trials Institute At Northwest Arkansas
  Fayetteville, Arkansas, United States Recruiting

+48 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)
• Email: medinfo@incyte.com
• Phone: 1.855.463.3463

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ruxolitinib cream for children 6 to under 12 with nonsegmental vitiligo

  This will test whether ruxolitinib cream can safely produce skin repigmentation in children aged 6 to under 12 with nonsegmental vitiligo.

  Recruiting at 78 sites Phase 3 Incyte Corporation · Buenos Aires and 77 other locations · NCT06804811

• Graft-versus-host disease after stem cell transplant: testing LBP-MARCO with ruxolitinib

  We are testing whether combining LBP-MARCO with ruxolitinib is safe for adults with GVHD after a stem cell transplant.

  Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07913672

• DMR-001 in CALR-mutant myeloproliferative neoplasms

  This study tests DMR-001 alone for CALR-mutant essential thrombocythemia or myelofibrosis, and in combination with ruxolitinib for CALR-mutant myelofibrosis.

  Recruiting at 3 sites Phase 1 Damora Therapeutics · Birmingham, Alabama and 35 other locations · NCT07849231

• Testing WJ01024 Alone and with Ruxolitinib for Myelofibrosis with Splenomegaly

  This early-phase study tests whether WJ01024, by itself or with ruxolitinib, is safe and tolerable and whether it shows signs of activity in adults with myelofibrosis and enlarged spleen.

  Recruiting Phase 1 Henan Cancer Hospital · Zhengzhou, Henan · NCT07802405

• Belumosudil vs. Ruxolitinib for hepatic cGVHD after HSCT

  This trial tests whether belumosudil or ruxolitinib works better for hepatic chronic GVHD after a stem cell transplant in people 12 and older.

  Recruiting First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT07794514

• Topical ruxolitinib for adults with pyoderma gangrenosum

  This pilot study tests a topical cream of ruxolitinib to see if it helps heal PG ulcers in adults without adding systemic immunosuppressants.

  Recruiting Phase 2 Oregon Health and Science University · Portland, Oregon · NCT07783412

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.