NCT03725722|CompletedPhase 2ResultsFDA Drug

Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over an 8-week Treatment Period in Adult Subjects With Atopic Dermatitis.

A Phase 2b, Double-blind, Randomised, 5-arm, Vehicle-controlled, Dose Ranging Trial to Evaluate the Efficacy and Safety of Twice Daily Topical Applications of Delgocitinib Cream 1, 3, 8, 20 mg/g for 8 Weeks in Adult Subjects With Mild to Severe Atopic Dermatitis.

LEO Pharma ClinicalTrials.gov

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1 other identifier

LP0133-1275

Study Type

interventional

Target

251

Locations

3 countries

Sites

Timeline

RegisteredOct 2018

StartedDec 2018

CompletionMay 2020

Brief Summary

This is a double-blind, multi-centre, randomised, 5-arm, vehicle-controlled, parallel-group trial. The trial is designed to establish a dose-response signal and investigate the efficacy and safety of delgocitinib cream in the treatment of adult subjects with mild to severe atopic dermatitis (AD).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

251

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Dec 2018

Shorter than P25 for phase_2

Geographic Reach

3 countries

31 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

First Submitted

Initial submission to the registry

October 30, 2018

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed

2 months until next milestone

Study Start

First participant enrolled

December 28, 2018

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2020

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

July 8, 2021

Completed

Last Updated

March 12, 2025

Status Verified

June 1, 2021

Enrollment Period

1.4 years

First QC Date

October 30, 2018

Results QC Date

May 7, 2021

Last Update Submit

February 21, 2025

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

Change From Baseline (Week 0) to Week 8 in Eczema Area and Severity Index (EASI) Score.
EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition. The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose selection. Mixed Model for Repeated Measurements (MMRM) analysis was used to determine the difference in the continuous endpoint between the active delgocitinib doses and delgocitinib cream vehicle.
Week 0 to Week 8

Secondary Outcomes (3)

Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) Score of 0 (Clear) or 1 (Almost Clear) With ≥2-step Improvement (vIGA-AD TS) From Baseline to Week 8.
Week 0 to Week 8
EASI75 at Week 8
Week 0 to Week 8
Time to vIGA-AD TS
Week 0 to Week 8

Study Arms (5)

Delgocitinib cream 1 mg/g

EXPERIMENTAL

Delgocitinib cream applied twice daily for 8 weeks

Drug: Delgocitinib cream

Delgocitinib cream 3 mg/g

EXPERIMENTAL

Delgocitinib cream applied twice daily for 8 weeks

Drug: Delgocitinib cream

Delgocitinib cream 8 mg/g

EXPERIMENTAL

Delgocitinib cream applied twice daily for 8 weeks

Drug: Delgocitinib cream

Delgocitinib cream 20 mg/g

EXPERIMENTAL

Delgocitinib cream applied twice daily for 8 weeks

Drug: Delgocitinib cream

Delgocitinib cream vehicle

PLACEBO COMPARATOR

Delgocitinib cream vehicle applied twice daily for 8 weeks

Drug: Delgocitinib cream vehicle

Interventions

Delgocitinib creamDRUG

Cream for topical application

Also known as: LEO 124249 cream

Delgocitinib cream 1 mg/gDelgocitinib cream 20 mg/gDelgocitinib cream 3 mg/gDelgocitinib cream 8 mg/g

Delgocitinib cream vehicleDRUG

The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Also known as: LEO 124249 cream vehicle

Delgocitinib cream vehicle

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18 years and above.
Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.
History of AD for ≥1 year.
AD involvement of 5-50% treatable body surface area at screening and at baseline (excluding scalp).
Disease severity graded as mild to severe according to vIGA-AD (i.e. vIGA-AD ≥2) at screening and baseline.

You may not qualify if:

AD lesion(s) on scalp at screening and/or baseline.
Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, rosacea, urticaria, or psoriasis.
Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
Use of tanning beds or phototherapy within 4 weeks prior to baseline.
Systemic treatment with immunosuppressive/modulating drugs or corticosteroids within 4 weeks prior to baseline or 3 or more bleach baths any week within 4 weeks prior to baseline.
Treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or oral antibiotics within 2 weeks prior to baseline.
Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e. the subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
Receipt of live attenuated vaccines within 4 weeks prior to baseline.
Treatment with any marketed or investigational biologic agents within 6 months or 5 half-lives prior to baseline, or until cell counts return to normal, whichever is longer.
History of any active skin infection within 1 week prior to baseline.
Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline.

Contact the study team to confirm eligibility.