NonSegmental Vitiligo study: Ruxolitinib Cream vs Vehicle Cream
Official title A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo
ClinicalTrials.gov ID: NCT06804811
What this study is testing
What is Ruxolitinib Cream?
This is an investigational cream being studied as a potential treatment for nonsegmental vitiligo in children. It is designed to block specific signals in the skin that cause immune cells to attack pigment-producing cells.
Also referred to as INCB018424 Phosphate Cream.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if ruxolitinib cream is safe and works for children with nonsegmental vitiligo.
- Who it's for
- Children aged 6 to under 12 who have nonsegmental vitiligo.
- What's involved
- Participants will use the study cream and visit the clinic for checkups and safety tests.
- Time commitment
- The study duration and specific visit schedule are not listed in the provided text.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 11
You may be able to join if
- Aged 6 to \< 12 years at the time of signing the ICF.
- Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3...
- 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.
You likely can't join if
- Diagnosis of other forms of vitiligo (eg, segmental).
- Other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory...
- 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).
- Concurrent conditions and history of protocol-defined diseases
- Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in...
See the full eligibility criteria
- Aged 6 to \< 12 years at the time of signing the ICF.
- Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 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 as defined in the protocol.
- 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...
- 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).
- Concurrent conditions and history of protocol-defined diseases
- 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...
- Use of protocol-defined treatments within the indicated washout period before baseline.
- History of treatment failure with any systemic or topical JAK inhibitor for vitiligo or any other inflammatory condition.
- Protocol-defined clinically significant abnormal laboratory values at screening.
- BMI-for-age \< 5th percentile or ≥ 85th percentile according to the CDC BMI Percentile Calculator for Child and Teen.
- 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.
- The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per...
- In the EU, participants considered incapacitated according to EU CTR No. 536/2014 Articles 2 and 31. Other protocol-defined Inclusion/Exclusion Criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Buenos Aires, Argentina
- Derqui-pilar, Argentina
- Mar del Plata, Argentina
- San Miguel de Tucumán, Argentina
- Graz, Austria
- Innsbruck, Austria
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Woluwe-Saint-Lambert, Belgium
- Dupnitsa, Bulgaria
- Gabrovo, Bulgaria
- Sevlievo, Bulgaria
- Sofia, Bulgaria
- Hellerup, Denmark
- Herlev, Denmark
- Argenteuil, France
- Bordeaux, France
- Créteil, France
- Lyon, France
+ 48 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Buenos Aires, Argentina; Derqui-pilar, Argentina; Mar del Plata, Argentina; San Miguel de Tucumán, Argentina; Graz, Austria; Innsbruck, Austria and 62 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.