Clinical trial NCT04587453: Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis
Official title: A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis Who Are Candidates for Systemic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2020-10-14
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective:

To evaluate the efficacy of tralokinumab in combination with topical corticosteroids (TCS) compared with placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD).

Secondary objectives:

To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, health-related quality of life, and health care resource utilisation compared with placebo in combination with TCS.

To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 16 weeks.


Eligibility criteria: Key inclusion criteria:

* Japanese subject aged 18 years and above.
* Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
* History of AD for 1 year or more.
* A recent history (within 1 year before screening) of inadequate response to treatment with topical medication.
* AD involvement of 10% or more body surface area at screening and at baseline according to component A of SCORAD.
* Applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.

Key exclusion criteria:

* Subjects for whom TCS are medically inadvisable e.g. due to important side effects or safety risks in the opinion of the investigator.
* Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
* Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
* Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 4 weeks prior to randomisation.
* Treatment with TCS, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or topical Janus kinase inhibitors within 2 weeks prior to randomisation.
* Receipt of any marketed biological therapy (i.e. immunoglobulin, anti-immunoglobulin E) including dupilumab or investigational biologic agents 3 to 6 months prior to randomisation.
* Active skin infections within 1 week prior to randomisation.
* Clinically significant infection within 4 weeks prior to randomisation.
* A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
* Tuberculosis requiring treatment within the 12 months prior to screening.
* Known primary immunodeficiency disorder.

Primary outcomes:
measure: Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
timeFrame: Week 16
measure: At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16
timeFrame: Week 0 to Week 16
Secondary outcomes:
measure: Change in Scoring Atopic Dermatitis (SCORAD) Total Score From Baseline to Week 16
timeFrame: Week 0 to Week 16
measure: Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16.
timeFrame: Week 0 to Week 16
measure: Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) Score (Weekly Average) of at Least 4 From Baseline to Week 16
timeFrame: Week 0 to Week 16
measure: At Least 90% Reduction in EASI (EASI90) at Week 16
timeFrame: Week 0 to Week 16
measure: At Least 50% Reduction in EASI (EASI50) at Week 16
timeFrame: Week 0 to Week 16
measure: Percentage Change in EASI Score From Baseline to Week 16
timeFrame: Week 0 to Week 16
measure: Change in Worst Daily Pruritus NRS Score (Weekly Average) From Baseline to Week 16
timeFrame: Week 0 to Week 16
measure: Change in Eczema-related Sleep NRS Score (Weekly Average) From Baseline to Week 16
timeFrame: Week 0 to Week 16
measure: Change in Patient-Oriented Eczema Measure (POEM) Score Form Baseline to Week 16
timeFrame: Week 0 to Week 16
measure: Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject
timeFrame: Week 0 to Week 16
measure: Number of Subjects With Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16
timeFrame: Week 0 to Week 16
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: LEO Investigational Site
state: Aichi
city: Ichikawa-city
country: Japan
facility: LEO Investigational Site
state: Chiba
city: Ichikawa-shi
country: Japan
facility: LEO Investigational Site
state: Chiba
city: Chikushino-city
country: Japan
facility: LEO Investigational Site
state: Fukuoka
city: Asahikawa
country: Japan
facility: LEO Investigational Site
state: Hokkaido
city: Chuo-Ku-Sapporo
country: Japan
facility: LEO Investigational Site
state: Hokkaido
city: Obihiro-shi
country: Japan
facility: LEO Investigational Site
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: LEO Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: LEO Investigational Site
state: Hokkaido
city: Nishinomiya
country: Japan
facility: LEO Investigational Site
state: Hyogo
city: Nonoichi
country: Japan
facility: LEO Investigational Site
state: Ishikawa
city: Kagoshima-shi
country: Japan
facility: LEO Investigational Site
state: Kagoshima
city: Kawasaki-shi
country: Japan
facility: LEO Investigational Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: LEO Investigational Site
state: Kanagawa
city: Yokohama
country: Japan
facility: LEO Investigational Site
state: Kanagawa
city: Kamigyo-ku
country: Japan
facility: LEO Investigational Site
state: Kyoto
city: Tokyo
country: Japan
facility: LEO Investigational Site
state: Minato
city: Osaka-shi
country: Japan
facility: LEO Investigational Site
state: Osaka
city: Sakai-shi
country: Japan
facility: LEO Investigational Site
state: Osaka
city: Toyonaka-shi
country: Japan
facility: LEO Investigational Site
state: Osaka
city: Koto-ku
country: Japan
facility: LEO Investigational Site
state: Tokyo
city: Setagaya
country: Japan
facility: LEO Investigational Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: LEO Investigational Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: LEO Investigational Site
state: Tokyo
city: Fukuoka
country: Japan
facility: LEO Investigational Site
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: