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Completed

NCT Number: NCT05127421

Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement

This is a randomized, double blind, vehicle controlled Phase 2 study with a 4-week open label extension in adolescent and adult participants with atopic dermatitis and head and/or neck involvement. It is intended to compare the efficacy and safety of ruxolitinib cream 1.5% BID versus vehicle cream, then further evaluate ruxolitinib cream as maintenance during the open label extension period.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Science37

Culver City, California, 90230, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with diagnosis of AD for at least 6 months.
  • Participants with an overall and a face and/or neck IGA score of 2 or 3 at screening and baseline.
  • Participants with AD affecting the following at screening and baseline:
  • ≥ 0.5% of the total BSA on the face and/or neck
  • Up to a total of 20% BSA (face and/or neck plus other body areas)
  • Willingness to avoid pregnancy or fathering children based on the criteria outlined in the protocol.
  • Further inclusion criteria apply.

Exclusion criteria

  • Participants who have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to baseline.
  • Participants with concurrent conditions and history of other diseases such as immunocompromised; chronic or acute infection requiring systemic treatments; active acute skin infection; other concomitant skin conditions that may interfere with the evaluation of AD or compromise participant safety; other types of eczema; chronic asthma requiring high dose of inhaled corticosteroids.
  • 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.
  • Previous treatment with systemic or topical JAK inhibitors (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
  • Participants who are pregnant (or who are considering pregnancy) or lactating.
  • Laboratory values outside of the protocol -defined criteria
  • Further exclusion criteria apply.

Treatment and study plan

Ruxolitinib Cream

Drug

Ruxolitinib cream 1.5% applied twice a day (BID)"

Vehicle

Drug

Vehicle cream applied twice a day (BID) to affected areas

Primary outcomes

  1. Percentage of Participants Who Achieve a ≥75% Improvement in the Eczema Area and Severity Index Score (EASI75) of the Head and Neck Region at Week 4

    Time frame: Baseline; Week 4

    The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72; the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. Specifically for the head and neck region, the EASI score ranges from 0 to 7.2 An EASI75 responder was defined as a participant achieving a 75% or greater improvement from Baseline in the EASI score for the head and neck.

Secondary outcomes

  1. Percentage of Participants Who Achieve an EASI75 of the Head and Neck Region at Weeks 2 and 8

    Time frame: Baseline; Weeks 2 and 8

    The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72; the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. Specifically for the head and neck region, the EASI score ranges from 0 to 7.2 An EASI75 responder was defined as a participant achieving a 75% or greater improvement from Baseline in the EASI score for the head and neck.

  2. Percentage of Participants Who Achieve an Overall EASI75 at Weeks 2, 4, and 8

    Time frame: Baseline; Weeks 2, 4, and 8

    The EASI scoring system examines 4 areas of the body (head/neck, trunk, upper limbs, and lower limbs) and weights them for participants of at least 8 years of age. Each of the 4 body regions is assessed separately for erythema (E), induration/papulation/edema (I), excoriations (Ex), and lichenification (l) on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72; the severity strata are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. An EASI75 responder was defined as a participant achieving 75% or greater improvement from Baseline in EASI score.

  3. Double-Blind Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

    Time frame: up to approximately 4 weeks plus 30 days

    A TEAE was defined as any adverse event (AE) either reported for the first time or the worsening of a pre-existing event after the first application of the study drug. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug.

  4. Open-Label Period: Number of Participants With Any TEAE

    Time frame: from first dose date in Open-Label Period (start of Week 5) until last follow-up visit (up to approximately 4 weeks plus 30 days)

    A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of the study drug. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug.

  5. Double-Blind Period: Number of Participants With Any Grade 3 or Higher TEAE

    Time frame: up to approximately 4 weeks plus 30 days

    A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of the study drug. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. The severity of AEs was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grades 1 to 5). Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE.

  6. Open-Label Period: Number of Participants With Any Grade 3 or Higher TEAE

    Time frame: from first dose date in Open-Label Period (start of Week 5) until last follow-up visit (up to approximately 4 weeks plus 30 days)

    A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of the study drug. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

A Phase 2, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 19, 2021
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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