The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis

NCT04839380 | Completed Phase 2 Results FDA Drug

• 1 other identifier: INCB 18424-901
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to evaluate the effect of ruxolitinib cream on itch in participants with Atopic Dermatitis.

Conditions

Atopic Dermatitis

Keywords

ruxolitinib; Itch; Chronic Pruritus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Day 2 (24-hour Recall Period After First Application)

  The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period.

  Baseline; Day 2

Secondary Outcomes (12)

• Change From Baseline in the Modified Peak-Pruritus Numerical Rating Scale (mPP-NRS) Score (Current Itch Intensity) at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1

  Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose)

• Change From Baseline in the PP-NRS Score From Day 3 Through Day 29 (24-hour Recall Period After First Application)

  Baseline; Day 3 through Day 29

• Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1

  Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose)

• Percentage of Participants Achieving at Least a 1-grade Decrease From Baseline in the PP-NRS Score From Day 2 Through Day 29

  Baseline; Day 2 through Day 29

• Percentage of Participants Achieving at Least a 2-grade Decrease From Baseline in the mPP-NRS Score at 15 and 30 Minutes Postdose and at 1, 2, 4, 6, and 12 Hours Postdose on Day 1

  Baseline; Day 1 (15 and 30 minutes postdose; 1, 2, 4, 6, and 12 hours postdose)

Study Arms (1)

Treatment Group : Ruxolitinib

EXPERIMENTAL

ruxolitinib cream 1.5% will be applied twice daily as a thin film.

Drug: ruxolitinib cream

Interventions

ruxolitinib cream DRUG

ruxolitinib cream 1.5% will be applied twice daily as a thin film

Also known as: INCB018424

Treatment Group : Ruxolitinib

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has clinically confirmed diagnosis of active AD for at least a 6-months.
• Participant has chronic pruritus related to AD for at least 3 months .
• Participant has an overall BSA (excluding palms, soles, scalp, genitals, and folds) affected by AD of 1%-20% on Day 1.
• Participant has an IGA score of at least 2 on Day 1.
• Participant has a single PP-NRS score ≥ 4 in the 24-hour period prior to the screening visit.
• Willingness to avoid pregnancy or fathering children.
• Participant must be willing to comply with all study procedures and restrictions including discontinuation of all current therapies for AD and pruritus (unless otherwise specified), and must be available for the duration of the study.

You may not qualify if:

• Female participnat who is breastfeeding, pregnant, or planning to become pregnant during the study.
• Participant had significant flares or unstable course in AD.
• Participant has clinically infected AD or has used antibiotics (systemic or topical) for their infected AD within 2 weeks prior to the run-in period.
• Participant has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
• Participant has any clinically significant medical condition or physical/laboratory/vital sign abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.
• Participant has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the run-in period.
• Participant is unlikely, in the opinion of the investigator, to be compliant with study procedures and requirements.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (2)

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Innovoderm Research

Montreal, Quebec, H2K 4LS, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Pruritus

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 9, 2021
• Study Start: October 12, 2021
• Primary Completion: November 18, 2022
• Study Completion: November 18, 2022
• Last Updated: October 31, 2023
• Results First Posted: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

CA (2)