Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis

NCT04587453 | Completed Phase 3 Results FDA Drug

• 1 other identifier: LP0162-1343
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 25

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16

  IGA is an instrument used in clinical trials to rate the severity of the participant's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  Week 16

• At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16

  Eczema Area and Severity Index (EASI) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition.

  Week 0 to Week 16

Secondary Outcomes (11)

• Change in Scoring Atopic Dermatitis (SCORAD) Total Score From Baseline to Week 16

  Week 0 to Week 16

• Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16.

  Week 0 to Week 16

• Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) Score (Weekly Average) of at Least 4 From Baseline to Week 16

  Week 0 to Week 16

• At Least 90% Reduction in EASI (EASI90) at Week 16

  Week 0 to Week 16

• At Least 50% Reduction in EASI (EASI50) at Week 16

  Week 0 to Week 16

Study Arms (2)

Tralokinumab+TCS

EXPERIMENTAL

Week 0 to Week 16: Tralokinumab will be given as subcutaneous injections. Participants will receive tralokinumab loading dose on Day 0 followed by multiple tralokinumab injections. The last administration will occur at Week 14. Topical corticosteroids (TCS) will be administered as needed.

Drug: Tralokinumab; Other: Topical corticosteroids (TCS)

Placebo+TCS

PLACEBO COMPARATOR

Week 0 to Week 16: Placebo will be given as subcutaneous injections. Participants will receive placebo loading dose on Day 0 followed by multiple placebo injections. The last administration will occur at Week 14. Topical corticosteroids (TCS) will be administered as needed.

Drug: Placebo; Other: Topical corticosteroids (TCS)

Interventions

Tralokinumab DRUG

Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 subclass that specifically binds to human interleukin-13 (IL-13) and blocks the interaction with IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.

Tralokinumab+TCS

Placebo DRUG

Placebo contains the same excipients in the same concentration only lacking tralokinumab.

Placebo+TCS

Topical corticosteroids (TCS) OTHER

TCS administered as needed.

Placebo+TCS; Tralokinumab+TCS

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (25)

LEO Investigational Site

Nagoya, Aichi-ken, 457-8510, Japan

Location

LEO Investigational Site

Ichikawa, Chiba, 272-0143, Japan

Location

LEO Investigational Site

Ichikawa-shi, Chiba, 272-0033, Japan

Location

LEO Investigational Site

Chikushino-shi, Fukuoka, 818-0083, Japan

Location

LEO Investigational Site

Asahikawa, Hokkaido, 070-8610, Japan

Location

LEO Investigational Site

Chuo-Ku-Sapporo, Hokkaido, 060-0063, Japan

Location

LEO Investigational Site

Obihiro-shi, Hokkaido, 080-0013, Japan

Location

LEO Investigational Site

Sapporo, Hokkaido, 060-0807, Japan

Location

LEO Investigational Site

Sapporo, Hokkaido, 063-0812, Japan

Location

LEO Investigational Site

Nishinomiya, Hyōgo, 663-8186, Japan

Location

LEO Investigational Site

Nonoichi, Ishikawa-ken, 921-8801, Japan

Location

LEO Investigational Site

Kagoshima, Kagoshima-ken, 890-0063, Japan

Location

LEO Investigational Site

Kawasaki-shi, Kanagawa, 211-0063, Japan

Location

LEO Investigational Site

Yokohama, Kanagawa, 220-6208, Japan

Location

LEO Investigational Site

Yokohama, Kanagawa, 221-0825, Japan

Location

LEO Investigational Site

Kamigyō-ku, Kyoto, 602-8566, Japan

Location

LEO Investigational Site

Tokyo, Minato, 108-0014, Japan

Location

LEO Investigational Site

Osaka, Osaka, 532-0003, Japan

Location

LEO Investigational Site

Sakai-shi, Osaka, 593-8324, Japan

Location

LEO Investigational Site

Toyonaka-shi, Osaka, 560-0085, Japan

Location

LEO Investigational Site

Koto-ku, Tokyo, 136-0074, Japan

Location

LEO Investigational Site

Setagaya City, Tokyo, 158-0097, Japan

Location

LEO Investigational Site

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

LEO Investigational Site

Shinjuku-ku, Tokyo, 169-0075, Japan

Location

LEO Investigational Site

Fukuoka, 814-0171, Japan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

tralokinumab; Adrenal Cortex Hormones

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

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

The trial was not powered to show superiority of tralokinumab+TCS vs placebo+TCS, but to facilitate an evaluation of similarity with the treatment effect observed in the LP0162-1339 trial (EU and US). The first 16 weeks were similar in the 2 trials.

Results Point of Contact

• Title: Clinical Disclosure
• Organization: Leo Pharma A/S

disclosure@leo-pharma.com

+45 4494 5888

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the trial participant nor any of the investigator or LEO pharma staff who are involved in the treatment or clinical evaluation and monitoring of the participants will be aware of the treatment received. The packaging and labelling of the investigational medicinal product (IMP) will contain no evidence of their identity. Since tralokinumab and placebo are visually distinct and not matched for viscosity, IMP will be handled and administered by a qualified, unblinded healthcare professional at the site who will not be involved in the management of trial participants and who will not perform any of the assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 14, 2020
• Study Start: October 27, 2020
• Primary Completion: July 6, 2021
• Study Completion: July 15, 2021
• Last Updated: March 11, 2025
• Results First Posted: September 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (25)