Study of Ruxolitinib Cream in Adolescents With Atopic Dermatitis

Atopic Dermatitis (AD) Clinical Trial

Official title:

A Phase 3, Open-Label, One-Year Safety Study of Ruxolitinib Cream in Adolescents (Ages ≥ 12 Years to < 18 Years) With Atopic Dermatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05456529
• Other study ID #: INCB 18424-315
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 1, 2022
• Est. completion date: April 29, 2024

Study information

• Verified date: April 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the long-term safety and tolerability of ruxolitinib cream in adolescents with Atopic Dermatitis (AD).

Description:

The study comprises of a 8 week continuous treatment period followed by 44 week Long Term Safety (LTS) period and 30 days safety follow up period. During Continuous treatment period all lesions identified at baseline will be treated and during LTS period only active lesions will be treated.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 103
• Est. completion date: April 29, 2024
• Est. primary completion date: April 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• A diagnosis of Atopic Dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria.

• Duration of AD of at least 2 years.

• Total IGA score of 2 to 3 at the screening and baseline visits.

• Percent BSA (excluding the scalp) with AD involvement of 3% to 20% at the screening and baseline visits.

• Atopic dermatitis not adequately controlled with other topical prescription therapies or when those therapies are not advisable.

• Agree to discontinue all agents used to treat AD from screening through the final follow up visit.

• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

• An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.

• Concurrent conditions and history of other diseases

• Any current and/or history of 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. For example:

• Clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction or stroke within 6 months from Day 1 of study cream application, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy or uncontrolled hypertension (blood pressure > 150/90 mm Hg) unless approved by the medical monitor/sponsor.

• Current and/or history of malignancy in the 5 years preceding the baseline visit, except for adequately treated, nonmetastatic nonmelanoma skin cancer.

• Current and/or history of arterial or venous thrombosis, including DVT and PE.

• Current and/or history of active tuberculosis or current and/or history of latent tuberculosis unless adequately treated.

• Any of the following clinical laboratory test results at screening:

1. Hemoglobin < 100 g/L (< 10 g/dL)

2. Liver function tests:

• AST or ALT = 2.5 × ULN

• Total bilirubin > 1.5 × ULN with the exception of Gilbert disease. c. Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (using the CKD Epidemiology Collaboration equation).

d. Positive serology test results for HIV antibody. e. Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant.

• Use of any of the following treatments within the indicated washout period before baseline:

1. 5 half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab).

2. 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus).

3. 2 weeks - immunizations with live-attenuated vaccines; sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted).

Note: Live-attenuated vaccines are not recommended during the CT period. Note:

COVID-19 vaccination is allowed.

4. 1 week - use of other topical treatments for AD (other than bland emollients, eg, Aveeno® creams, ointments, sprays, soap substitutes), such as topical antipruritics (eg, doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), antibiotics, or antibacterial cleansing body wash/soap.

Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study.

• Previously received systemic or topical JAK inhibitors (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).

• Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's AD.

• Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with another investigational medication or current enrollment in another investigational drug protocol.

• Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with a strong CYP3A4 inhibitor.

• Inability to draw blood for PK analysis from any nonlesional areas.

• Known allergy or reaction to any component of the study cream formulation.

• In the opinion of the investigator unable or unlikely to comply with the administration schedule and study evaluations.

Further exclusion criteria may apply.

Related Conditions & MeSH terms

• Atopic Dermatitis (AD)
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Ruxolitinib Cream
Ruxolitinib cream 1.5% twice daily (BID) during the continuous and LTS treatment period.

Locations

Country	Name	City	State
Canada	Dermatology Research Institute	Calgary	Alberta
Canada	Lmc Manna Research (London)	London	Ontario
Canada	Dr. Chih-Ho Hong Medical Inc.	Surrey	British Columbia
Canada	Manna Research Toronto	Toronto	Ontario
Canada	K. Papp Clinical Research	Waterloo	Ontario
Canada	Xlr8 Medical Research	Windsor	Ontario
Poland	Centrum Medyczne Pratia Czestochowa	Czestochowa
Poland	Centrum Medyczne Angelius Provita	Katowice
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1	Lublin
Poland	Dermedic Dr. Zdybski	Ostrowiec Swietokrzyski
Poland	Klinika Ambroziak	Warsaw
Poland	Centrum Medyczne Evimed	Warszawa
United States	Arlington Research Center	Arlington	Texas
United States	Meridian Clinical Research	Baton Rouge	Louisiana
United States	Iact Health	Columbus	Georgia
United States	Ohio Pediatric Research Association	Dayton	Ohio
United States	Aventiv Research Inc-Dublin	Dublin	Ohio
United States	Empire Dermatology	East Syracuse	New York
United States	First Oc Dermatology	Fountain Valley	California
United States	Encore Medical Research, Llc Hollywood	Hollywood	Florida
United States	Solutions Through Advanced Research, Inc	Jacksonville	Florida
United States	Dermatology Research Associates	Los Angeles	California
United States	Apex Clinical Research Center	Mayfield Heights	Ohio
United States	Acevedo Clinical Research	Miami	Florida
United States	Skin Research of South Florida, Llc	Miami	Florida
United States	Well Pharma Medical Research Corp.	Miami	Florida
United States	International Clinical Research Tennessee Llc	Murfreesboro	Tennessee
United States	Sadick Dermatology Sadick Research Group	New York	New York
United States	Sneeze Wheeze and Itch Associates Llc	Normal	Illinois
United States	Arkansas Research Trials	North Little Rock	Arkansas
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Skin Specialists Pc the Advanced Skin Research Center	Omaha	Nebraska
United States	Peninsula Research Associates Pra	Rolling Hills Estates	California
United States	Progressive Clinical Research	San Antonio	Texas
United States	Northshore University Health System	Skokie	Illinois
United States	Forward Clinical Trials	Tampa	Florida
United States	Jordan Valley Medical Center	West Jordan	Utah
United States	Advanced Rx Clinical Research Group, Inc	Westminster	California

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Canada,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Treatment-emergent adverse events (TEAEs)	TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.	Baseline up to 56 weeks
Secondary	Number of participants with clinically notable vital sign changes from baseline	Changes in vital signs assessment of blood pressure, pulse, respiration rate, and body temperature.	Baseline up to week 52
Secondary	Number of participants with clinically significant changes from Baseline in height	Changes in height will be assessed.	Baseline up to week 52
Secondary	Number of participants with clinically significant changes from Baseline in weight	Changes in weight will be assessed.	Baseline up to week 52
Secondary	Number of participants with changes from baseline outside the normal range for clinically laboratory parameter values	Laboratory test values outside the normal range will be assessed for severity based on the normal ranges for the clinical reference laboratory.	Baseline up to week 52
Secondary	Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations	Trough concentration is defined as drug concentration in blood and/or saliva sampling.	Predose at weeks 2, 4, 8 followed by every 8 weeks through end of treatment (weeks 12, 20, 28, 36, 44 and 52)