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Completed

NCT Number: NCT06213831

A Study to Evaluate the Safety and Tolerability of Maximal Use Ruxolitinib Cream

This study is being conducted to determine the safety and tolerability of ruxolitinib 1.5% cream under maximal use conditions in participants with Prurigo Nodularis (PN).

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Saguaro Dermatology, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of PN ≥ 3 months before screening.
  • Pruriginous lesions (defined as papules, nodules, plaques, umbilicated lesions, and linear lesions) on ≥ 2 different body areas (such as right and left leg) at screening and baseline.
  • Total estimated treatment BSA ≥ 25% (excluding the scalp) at screening and baseline.
  • IGA-CPG-S score of ≥ 2 at screening and baseline.
  • Baseline PN-related WI-NRS score ≥ 7. Baseline WI-NRS score is defined as the 7-day average of WI-NRS scores before Day 1 (data from a minimum of 4 out of 7 days prior to Day 1 is needed).

Exclusion criteria

  • Chronic or acute pruritus due to a condition other than PN.
  • Active AD lesions (signs and symptoms other than dry skin) within 6 months of screening and baseline.
  • Acute or chronic active HBV or HCV infection.
  • Any underlying condition known to be associated with the clinical presentation of PN that is not under control (stable) prior to the baseline visit.
  • 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 cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Treatment and study plan

Ruxolitinib Cream 1.5%

Drug

Ruxolitinib Cream 1.5%

Primary outcomes

  1. Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to 16 weeks, including 30 days of safety follow-up

    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

  2. Number of participants with TEAEs leading to dose interruption or discontinuation

    Time frame: Up to 16 weeks, including 30 days of safety follow-up

    Number of participants with TEAEs leading to dose interruption or discontinuation.

Secondary outcomes

  1. Ruxolitinib pharmacokinetic (PK) parameters in plasma

    Time frame: Up to 16 weeks, including 30 days of safety follow-up

    Ruxolitinib concentration in plasma.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

A Maximal Use Trial of Ruxolitinib Cream in Adult Participants With Prurigo Nodularis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 19, 2024
Registry last updated
Aug 13, 2025

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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