A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)

• Sponsor: Incyte Corporation (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04921969
• Collaborator: (none)
• Enrollment: 250
• Locations: 52
• Arms: 3
• Anticipated Duration (Months): 27
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children with Atopic Dermatitis. This is a randomized, double-blind, Vehicle Controlled study. Participants will be randomized 2:2:1 to blinded treatment with ruxolitinib cream 0.75% ,1.5% , or vehicle cream, with stratification by baseline IGA score and age. At Week 8, efficacy will be evaluated. Participants who complete Week 8 assessments with no additional safety concerns will continue into the 44-week Long Term Safety (LTS) period with the same treatment regimen, except those initially randomized to vehicle cream will be rerandomized (1:1) in a blinded manner to 1 of the 2 active treatment groups (ruxolitinib cream 0.75% or 1.5%).

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Ruxolitinib; Drug: Vehicle Cream	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Children (Ages≥ 2 Years to < 12 Years) With Atopic Dermatitis ((TRuE-AD3)
• Actual Study Start Date: Jul 19, 2021
• Anticipated Primary Completion Date: Oct 18, 2023
• Anticipated Study Completion Date: Oct 18, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ruxolitinib (1.5% Cream) Study drug will be administered twice daiily.	Drug: Ruxolitinib; The study cream will be applied topically twice a day for up to 52 weeks.; Other Names: Jakafi
Experimental: Ruxolitinib (0.75% cream) Study drug will be administered twice daily.	Drug: Ruxolitinib; The study cream will be applied topically twice a day for up to 52 weeks.; Other Names: Jakafi
Placebo Comparator: Vehicle Cream Vehicle cream will be administered twice daily.	Drug: Vehicle Cream; Matching vehicle cream will be applied topically twice a day for up to 8 weeks.; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. Proportion of Participants who achieve Investigator's Global Assessment Treatment Success (IGA-TS) [Week 8]

   Defined as Investigator's Global Assessment (IGA) score of 0 or 1 with ≥ 2 grade improvement from baseline.

Secondary Outcome Measures

1. Proportion of participants who achieve Eczema Area and Severity Index (EASI75) [Week 8]

   Defined as ≥ 75% improvement in Eczema Area and Severity Index (EASI) score.

2. Proportion of participants with a ≥ 4-point improvement in Itch Numerical Rating Scale (NRS) score from baseline to Week 8. [Week 8]

   NRS assessments will be reported by the participants ≥6 years of age, via Diary once daily beginning on the day of screening through the last application of study drug during the VC period. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).

3. Number of Treatment Emergent Adverse Events (TEAEs) [Up to 61 weeks]

   Adverse events reported for the first time or worsening of a pre-existing event after the first application of study drug/treatment.

4. Proportion of participants who achieve IGA-TS at Weeks 2 and 4. [Week 2 and 4]

   Defined as Investigator's Global Assessment (IGA) score of 0 or 1 with ≥ 2 grade improvement from baseline.

5. Proportion of participants with a ≥ 4-point improvement in Itch NRS score from baseline to Weeks 2 and 4. [Weeks 2 and 4]

   NRS assessments will be reported by the participants ≥6 years of age, via Diary once daily beginning on the day of screening through the last application of study drug during the VC period. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity. A participant was a 4-point responder if their change from baseline is ≤ -4 (i.e. a decrease of at least 4).

6. Proportion of participants who achieve EASI75 at Weeks 2 and 4. [Weeks 2 and 4]

   Defined as ≥ 75% improvement in Eczema Area and Severity Index (EASI) score.

7. Time to achieve Itch NRS score improvement of at least 2 or 4 points. [Week 8]

   Defined as time taken by participants to achieve a 2 or 4 point improvement on itch NRS scale. The Itch NRS is a validated, self reported, instrument for measurement of itch intensity and participants were asked to rate the intensity of their itch on an 11- point scale ranging from 0 (no itch) to 10 (worst itch imaginable); higher scores indicated greater itch intensity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants diagnosed with Atopic Dermatitis (AD) as defined by the Hanifin and Rajka criteria.

• Participants with AD duration of at least 3 months (participant/parent/guardian may verbally report signs and symptoms of AD with onset at least 3 months prior).

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

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

• For children aged 6 years to < 12 years, baseline itch NRS score ≥ 4.

• Participants/guardians who agree to discontinue all agents used by the participant to treat AD from the screening visit through the final safety follow-up visit.

• Participants with at least 1 target lesion that measures at least 5 cm2 at the screening and baseline visits. The target lesion must be representative of the participant's disease state but not located on the hands, feet, or genitalia.

• Willingness to avoid pregnancy or fathering a child for the duration of study participation.

Exclusion Criteria:

• An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before the baseline visit.

• Concurrent conditions and history of other diseases as follows:

1. Immunocompromised

2. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit.

3. Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.

4. Any other concomitant skin disorder, pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of AD lesions or compromise participant safety.

5. Presence of AD lesions only on the hands or feet without prior history of involvement of other classic areas of involvement such as the face or the flexural folds.

6. Other types of eczema.

7. Chronic asthma requiring more than 880 µg of inhaled budesonide or equivalent high dose of other 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.

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

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

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

3. 2 weeks - immunizations with activated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted). Note: Live vaccines are not recommended during the VC period.

4. 1 week - use of topical treatments for AD (other than bland emollients, eg, Aveeno® creams, ointments, sprays, soap substitutes), such as corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), topical 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.

• Participants who have previously received JAK inhibitors, systemic or topical. -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.-

• Positive serology test results at screening for HIV antibody.

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

• Inadequate venous access in nonlesional areas for laboratory blood draws.

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

• Employees of the sponsor or investigator or otherwise dependents of them.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Center of Alabama	Birmingham	Alabama	United States	35209
2	Cahaba Dermatology	Hoover	Alabama	United States	35244
3	Desert Sky Dermatology	Gilbert	Arizona	United States	85295
4	Burke Pharmaceutical Research	Hot Springs National Park	Arkansas	United States	71913
5	Metropolis Dermatology	Los Angeles	California	United States	90017
6	University of Southern California	Los Angeles	California	United States	90033
7	Dermatology Research Associates	Los Angeles	California	United States	90045
8	Allergy and Asthma Associates of Southern California - Crn	Mission Viejo	California	United States	92691
9	Palmtree Clinical Research - Clinedge - Ppds	Palm Springs	California	United States	92262
10	Integrated Research Group	Riverside	California	United States	92506
11	Clinical Science Institute Clinical Research Specialists Inc	Santa Monica	California	United States	90404
12	Life Clinical Trials	Margate	Florida	United States	33063
13	Acevedo Clinical Research	Miami	Florida	United States	33142
14	The Childrens Skin Center Csc Miami	Miami	Florida	United States	33155
15	Entrust Clinical Research	Miami	Florida	United States	33156
16	Ciocca Dermatology Pa	Miami	Florida	United States	33173
17	Forcare Clinical Research Fcr Forward Clinical Trials, Inc	Tampa	Florida	United States	33624
18	Aeroallergy Research Lab of Savannah	Savannah	Georgia	United States	31406
19	Midwest Allergy Sinus Asthma	Normal	Illinois	United States	61761
20	Northshore University Health System	Skokie	Illinois	United States	60076
21	Dermatology Specialists Research Ds Research Indiana Location	Clarksville	Indiana	United States	47129
22	Dawes Fretzin Clinical Research Group Llc	Indianapolis	Indiana	United States	46250
23	Kansas City Dermatology P.A.	Lenexa	Kansas	United States	66215
24	Delricht Clinical Research - Clinedge - Ppds Baton Rouge	Baton Rouge	Louisiana	United States	70809
25	Delricht Clinical Research Llc - Clinedge - Ppds	New Orleans	Louisiana	United States	70115
26	Lawrence J. Green, Md. Llc	Rockville	Maryland	United States	20850
27	Henry Ford Health System	Detroit	Michigan	United States	48202
28	Mayo Clinic	Rochester	Minnesota	United States	55905
29	Skin Specialists Pc the Advanced Skin Research Center	Omaha	Nebraska	United States	68144
30	Dr Bobby Buka, Md Greenwich Village	New York	New York	United States	10012
31	Nyu Langone Health	New York	New York	United States	10016
32	Ohio Pediatric Research Association	Dayton	Ohio	United States	45414
33	Velocity Clinical Research Grants Pass Clinical Research Institute of Southern Oregon Pc	Grants Pass	Oregon	United States	97527
34	Cyn3Rgy Research - Clinedge - Ppds	Gresham	Oregon	United States	97030
35	Velocity Clinical Research Medford Clinical Research Institute of Southern Oregon Pc	Medford	Oregon	United States	97504
36	Penn State College of Medicine	Hershey	Pennsylvania	United States	17033
37	Rhode Island Hospital	Providence	Rhode Island	United States	02903
38	Coastal Pediatric Associates	Charleston	South Carolina	United States	29414
39	Medical University of South Carolina	Charleston	South Carolina	United States	29425
40	International Clinical Research Tennessee Llc	Murfreesboro	Tennessee	United States	37130
41	Arlington Research Center	Arlington	Texas	United States	76011
42	Progressive Clinical Research	San Antonio	Texas	United States	78213
43	Allergy and Asthma Care of Waco, Pa	Waco	Texas	United States	76712
44	Springville Dermatology	Springville	Utah	United States	84663
45	Jordan Valley Medical Center	West Jordan	Utah	United States	84088
46	Pi Coor Clinical Research Llc	Burke	Virginia	United States	22015
47	Clinical Research Partners Llc	Richmond	Virginia	United States	23220
48	Dermatology Specialists of Spokane	Spokane	Washington	United States	99202
49	Children'S Hospital of Wisconsin	Milwaukee	Wisconsin	United States	53226
50	Institute For Skin Advancement	Calgary	Alberta	Canada	T3A 2N1
51	McMaster University Faculty of Health Sciences	Burlington	Ontario	Canada	L7R 4H9
52	Dermatology Ottawa Research Centre	Ottawa		Canada	K2C 3N2

Sponsors and Collaborators

• Incyte Corporation

Investigators

• Study Director: Brett Angel, MD, Incyte Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Incyte Corporation
• ClinicalTrials.gov Identifier: NCT04921969
• Other Study ID Numbers: INCB 18424-305
• First Posted: Jun 10, 2021
• Last Update Posted: Apr 8, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Incyte Corporation: Atopic Dermatitis; Ruxolitinib
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema

Study Results

No Results Posted as of Apr 8, 2022