Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis

• ClinicalTrials.gov Identifier: NCT05117060
• Recruitment Status: Recruiting
• First Posted: November 11, 2021
• Last Update Posted: November 28, 2022
• Sponsor: LEO Pharma
• Information provided by (Responsible Party): LEO Pharma

Tracking Information

• First Submitted Date: November 8, 2021
• First Posted Date: November 11, 2021
• Last Update Posted Date: November 28, 2022
• Actual Study Start Date: December 13, 2021
• Estimated Primary Completion Date: December 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 8, 2021)

Change in EASI from baseline to Week 16 [ Time Frame: Week 0 to Week 16 ]

The Eczema Area and Severity Index (EASI) is a validated measure used in clinical trials to evaluate the extent and severity of atopic dermatitis. EASI is a composite score ranging from 0 to 72 with higher scores indicating a more extensive or severe condition.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 8, 2021)

Number of adverse events from baseline to Week 16+3 days per subject [ Time Frame: Week 0 to Week 16+3 days ]

Only treatment-emergent adverse events will be reported for this outcome measure. An adverse event will be considered treatment emergent if occurring after the first dose of treatment (Week 0) and up until 3 days after the last dose of treatment (Week 16+3 days for a participant completing the 16-week treatment period).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis
• Official Title: A Phase 2 Trial to Evaluate the Efficacy and Safety of Orally Administered LEO 152020 Tablets Compared With Placebo Tablets for up to 16 Weeks of Treatment in Adults With Moderate to Severe Atopic Dermatitis

Brief Summary

This is an up to 22-week clinical study in adult participants with moderate to severe atopic dermatitis (AD).

The purpose of the study is to test a new tablet (LEO 152020) to see if it works to treat AD and what the side effects are when compared with a placebo tablet with no medical ingredient.

During the study, there will be a 16-week treatment period during which the participants will be asked to take the tablets. The participants will regularly visit the clinic for tests and the study doctor will evaluate their AD. The participants will also be asked to answer questions about their AD symptoms, itch, sleep, and quality of life.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

The outcome assessor is considered to be the person/people who will assess the outcome of the data/study and will in this study therefore be the sponsor.

To ensure masking across the interventions, each dose of treatment in the LEO 152020 tablet - Dose regimen 1 and LEO 152020 tablet - Dose regimen 2 arms will consist of a combination of LEO 152020 and LEO 152020 placebo tablets. In these arms, placebo will be used as a masking aid and is therefore considered neither a control nor an intervention.

Primary Purpose: Treatment

• Condition: Atopic Dermatitis

Intervention

• Drug: LEO 152020 tablet
  LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R) and prevent histamine from binding to the receptor. LEO 152020 is a tablet for oral administration.
• Drug: LEO 152020 placebo tablet
  LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo tablet contains the same excipients in the same concentration as LEO 152020 tablet, except the medical ingredient LEO 152020.

Study Arms

• Experimental: LEO 152020 tablet - Dose regimen 1
  Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
  Intervention: Drug: LEO 152020 tablet
• Experimental: LEO 152020 tablet - Dose regimen 2
  Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
  Intervention: Drug: LEO 152020 tablet
• Experimental: LEO 152020 tablet - Dose regimen 3
  Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
  Intervention: Drug: LEO 152020 tablet
• Placebo Comparator: LEO 152020 placebo tablet
  Participants will be asked to take tablets from Week 0 to Week 16 (end of treatment).
  Intervention: Drug: LEO 152020 placebo tablet

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 8, 2021): 224
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 6, 2023
• Estimated Primary Completion Date: December 30, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Adult, age 18 years or older at screening.
• Diagnosis of chronic atopic dermatitis (AD).
• History of AD ≥1 year prior to baseline.
• Recent (within 6 months prior to baseline) documented history of inadequate response to topical AD treatments or subject for whom topical AD treatments are medically inadvisable.
• 7.1≤ Eczema Area and Severity Index (EASI) ≤50 at baseline.
• Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score ≥3 at baseline.

Exclusion Criteria:

• Previous treatment with an oral histidine 4 receptor (H4R) antagonist (including LEO 152020) within 6 months prior to baseline.
• Previous treatment with 3 or more systemic AD treatments prior to screening.
• Women who are pregnant, intend to become pregnant, or are lactating.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Clinical Disclosure; (+1) 877-557-1168; clinicaltrialscontactus@leo-pharma.com

• Listed Location Countries: Australia, Canada, Czechia, Germany, Japan, Poland, Spain, United States

Administrative Information

• NCT Number: NCT05117060
• Other Study ID Numbers: LP0190-1488; 2020-004561-39 ( EudraCT Number ); U1111-1281-1895 ( Other Identifier: World Health Organization (WHO) )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: De-identified individual participant data (IPD) can be made available to researchers in a closed environment for a specified period of time.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: Data are available to request after results of the trial are available on leopharmatrials.com.
• Access Criteria: Data sharing is subject to approved scientifically sound research proposal and signed data sharing agreement.
• URL: http://leopharmatrials.com/for-professionals

• Current Responsible Party: LEO Pharma
• Original Responsible Party: Same as current
• Current Study Sponsor: LEO Pharma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Expert; LEO Pharma

• PRS Account: LEO Pharma
• Verification Date: November 2022