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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05117060
Recruitment Status : Recruiting
First Posted : November 11, 2021
Last Update Posted : November 28, 2022
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Tracking Information
First Submitted Date  ICMJE November 8, 2021
First Posted Date  ICMJE November 11, 2021
Last Update Posted Date November 28, 2022
Actual Study Start Date  ICMJE December 13, 2021
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2021)
224
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 6, 2023
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Disclosure (+1) 877-557-1168 clinicaltrialscontactus@leo-pharma.com
Listed Location Countries  ICMJE Australia,   Canada,   Czechia,   Germany,   Japan,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05117060
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE LEO Pharma
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Expert LEO Pharma
PRS Account LEO Pharma
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP