TRuE-CHE1: Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1

Sponsor

Incyte Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05219864

Collaborator

(none)

180

Enrollment

Locations

Arms

19.7

Anticipated Duration (Months)

3.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).

Condition or Disease	Intervention/Treatment	Phase
Hand Eczema	Drug: Ruxolitinib cream Drug: Vehicle	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will receive ruxolitinib cream (1.5%) or vehicle cream for 16 weeks, after which they will be offered the opportunity to receive ruxilitinib cream (1.5%) in the open-label treatment extension period for another 16 weeks.Participants will receive ruxolitinib cream (1.5%) or vehicle cream for 16 weeks, after which they will be offered the opportunity to receive ruxilitinib cream (1.5%) in the open-label treatment extension period for another 16 weeks.

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1 (TRuE-CHE1): A Phase 3, Double-Blind, Randomized, 16-Week, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Open-Label Extension Period in Adults With Chronic Hand Eczema

Anticipated Study Start Date :

Sep 15, 2022

Anticipated Primary Completion Date :

Dec 9, 2023

Anticipated Study Completion Date :

May 7, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ruxolitinib Ruxolitinib cream 1.5% twice daily (BID) for 16 weeks followed by ruxolitinib cream 1.5% BID for an additional 16-week treatment extension period.	Drug: Ruxolitinib cream Ruxolitinib cream is a topical formulation applied as a thin film to affected areas. Other Names: INCB18424 cream
Placebo Comparator: Vehicle Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.	Drug: Vehicle Vehicle cream is a topical formulation applied as a thin film to affected areas.

Arm

Intervention/Treatment

Experimental: Ruxolitinib

Ruxolitinib cream 1.5% twice daily (BID) for 16 weeks followed by ruxolitinib cream 1.5% BID for an additional 16-week treatment extension period.

Drug: Ruxolitinib cream

Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.

Other Names:

INCB18424 cream

Placebo Comparator: Vehicle

Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.

Drug: Vehicle

Vehicle cream is a topical formulation applied as a thin film to affected areas.

Outcome Measures

Primary Outcome Measures

Proportion of participants achieving Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) [Week 16]
The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.

Secondary Outcome Measures

Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score [Week 16]
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable) on a daily basis.
Proportion of participants with a ≥ 2-point improvement in CHE-related Pain NRS score [Week 16]
The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Change from baseline in the modified Total Lesion Symptom Score (mTLSS) [Up to Week 32]
The mTLSS is a validated tool for assessing hand eczema. The scale quantifies the 7 features (erythema, scaling, hyperkeratosis/lichenification, vesiculation, oedema, fissures, and pruritus/pain) of HE (0 = none, 1 = mild, 2 = moderate, and 3 = severe).
Proportion of participants achieving an IGA-CHE-TS from baseline [Up to Week 32]
The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.
Change from baseline in CHE-related Itch Numerical Rating Scale (NRS) score (weekly average) [Up to Week 32]
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Change from baseline in CHE-related Pain NRS score (weekly average) [Up to Week 32]
The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Time to ≥ 4-point improvement from baseline in CHE-related Itch NRS score [Up to Week 32]
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable) on a daily basis.
Time to ≥ 2-point improvement from baseline in CHE-related Pain NRS score. [Up to Week 32]
The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) on a daily basis.
Percentage change in Hand Eczema Severity Index (HECSI) [Week 16]
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales.
Proportion of Participants with HECSI-75 [Weeks 2, 8, 16 and 32]
HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales.
Proportion of participants with HECSI-90 [Weeks 2, 8, 16, and 32]
HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales.
Mean Patient Global Impression of Change (PGIC) score [Up to Week 32]
The Patient Global Impression of Change (PGIC)is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.
Proportion of participants with each score on the PGIC [Up to Week 32]
The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.
Proportion of Participants with a score of either 1 or 2 on the PGIC [Up to Week 32]
The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting > 3 months or ≥ 2 flares within the previous 12 months.
Screening and baseline IGA-CHE 3 or 4.
Baseline CHE-related Itch NRS ≥ 4.
Recent history (within the past 1 year of baseline) of inadequate response to treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), or oral alitretinoin; or intolerance or contraindication to TCS or TCI or oral alitretinoin.
Willingness to avoid pregnancy or fathering children based on the criteria below.

Exclusion Criteria:

Known triggers for CHE (allergic or irritant, such as those identified by previous patch tests) cannot be avoided during the course of this study.
Participants who have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
Participants with concurrent conditions and history of other diseases such as other active skin disease or infection on the hands; immunocompromised; chronic or acute infection requiring systemic treatments; active acute skin infection; other concomitant skin conditions that may interfere with study assessments or compromise participant safety; other types of eczema; chronic asthma requiring high dose of inhaled corticosteroids; current or history of hepatitis B or C virus infection.
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.
Laboratory values outside of the protocol-defined criteria.
Use of protocol-defined treatments within the indicated washout period before baseline.
Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks before baseline.
Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
Further exclusion criteria apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southwest Skin Specialists Phoenix Biltmore	Phoenix	Arizona	United States	85018
2	Raoof Md Encino	Encino	California	United States	91436
3	First Oc Dermatology	Fountain Valley	California	United States	92708
4	Marvel Clinical Research Llc	Huntington Beach	California	United States	92647
5	Well Pharma Medical Research Corporation	Miami	Florida	United States	33173
6	Psoriasis Treatment Center of South Florida	Pembroke Pines	Florida	United States	33028
7	Lenus Research Medical Group, Llc	Sweetwater	Florida	United States	33172
8	Delricht Research	Marietta	Georgia	United States	30060
9	Arlington Dermatology	Rolling Meadows	Illinois	United States	60008
10	Midwest Allergy Sinus Asthma, Sc	Springfield	Illinois	United States	62604
11	Dermatologist Specialist	Louisville	Kentucky	United States	40241
12	Grafton Dermatology and Cosmetic Surgery	Houma	Louisiana	United States	70364
13	Delricht Research	New Orleans	Louisiana	United States	70115
14	Washington University	Saint Louis	Missouri	United States	63110
15	Jubilee Clinical Research Inc	Las Vegas	Nevada	United States	89106
16	Juva Skin and Laser Center	New York	New York	United States	10022
17	Oregon Medical Research Center	Portland	Oregon	United States	97223
18	Oregon Health & Science University	Portland	Oregon	United States	97239
19	Clinical Neuroscience Solutions Cns Healthcare Memphis Research Center	Memphis	Tennessee	United States	38119
20	International Clinical Research Tennessee Llc	Murfreesboro	Tennessee	United States	37130
21	Austin Institute For Clinical Research Aicr Pflugerville	Houston	Texas	United States	77056
22	Progressive Clinical Research	San Antonio	Texas	United States	78213
23	Center For Clinical Studies Webster	Webster	Texas	United States	77598
24	University of Utah	Murray	Utah	United States	84107
25	West End Dermatology Associates	Richmond	Virginia	United States	23233
26	Dermatology Specialists of Spokane	Spokane	Washington	United States	99202
27	Dermatology Research Institute Inc.	Calgary	Alberta	Canada	T2J 7E1
28	Care Clinic	Red Deer	Alberta	Canada	T4P-1K4
29	Cca Medical Research	Ajax	Ontario	Canada	L1S 7K8
30	Lynderm Research Inc	Markham	Ontario	Canada	L3P 1X3
31	Fakultni Nemocnice U Sv. Anny V Brne	Brno		Czechia	656 91
32	Ccr Ostrava S.R.O.	Ostrava		Czechia	702 00
33	Ccr Czech A.S.	Pardubice		Czechia	53000
34	Clintrial S.R.O.	Praha 10		Czechia	100 00
35	Krajska Zdravotni A.S. - Masarykova Nemocnice V Usti Nad Labem O.Z.	Usti Nad Labem		Czechia	401 13
36	Universitaetsklinikum Frankfurt	Frankfurt		Germany	60590
37	Derma-Study-Center Friedrichshafen Gmbh	Friedrichshafen		Germany	88045
38	Dermatologikum Hamburg Gemeinschaftspraxis Gbr	Hamburg		Germany	20354
39	Universitaetsklinikum Schleswig-Holstein	Kiel		Germany	24105
40	Praxis Dr. Beate Schwarz	Langenau		Germany	89129
41	Beldio Research Gmbh	Memmingen		Germany	87700
42	Klifos - Klinische Forschung Osnabruck	Osnabruck		Germany	49074
43	Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.	Elblag		Poland	82-300
44	Centrum Medyczne Angelius Provita	Katowice		Poland	40-611
45	Centrum Medyczne Pratia Krakow	Krakow		Poland	30-002
46	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin		Poland	71-434
47	Etg Warszawa	Warszawa		Poland	02-793
48	Klinika Ambroziak Estederm	Warszawa		Poland	02-953
49	Dermmedica Sp. Z O.O.	Wroclaw		Poland	51-318
50	Hospital General Universitario de Alicante	Alicante		Spain	03010
51	Hospital de La Santa Creu I Sant Pau	Barcelona		Spain	08041
52	Hospital General Universitario Gregorio Maranon	Madrid		Spain	28007
53	Hospital de Manises	Manises		Spain	46940
54	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcon		Spain	28223