Trial Outcomes & Findings for An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis. (NCT NCT04922021)

NCT ID: NCT04922021

Last Updated: 2025-03-13

Results Overview

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 and/or severe condition.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

58 participants

Primary outcome timeframe

Week 0 to Week 16

Results posted on

2025-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	LEO 138559 Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment). LEO 138559: LEO 138559 is an antibody given by injection just under the skin.	Placebo Participants will receive injections of placebo from Week 0 (baseline) to Week 16 (end of treatment). LEO 138559 placebo: LEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except for the medical ingredient LEO 138559.
Overall Study STARTED	29	29
Overall Study COMPLETED	22	16
Overall Study NOT COMPLETED	7	13

Reasons for withdrawal

Reasons for withdrawal
Measure	LEO 138559 Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment). LEO 138559: LEO 138559 is an antibody given by injection just under the skin.	Placebo Participants will receive injections of placebo from Week 0 (baseline) to Week 16 (end of treatment). LEO 138559 placebo: LEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except for the medical ingredient LEO 138559.
Overall Study Withdrawal by Subject	4	10
Overall Study Adverse Event	2	2
Overall Study Lack of Efficacy	0	1
Overall Study Multiple reasons	1	0

Baseline Characteristics

An Evaluation of LEO 138559 in Adults With Moderate to Severe Atopic Dermatitis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LEO 138559 n=29 Participants Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment). LEO 138559: LEO 138559 is an antibody given by injection just under the skin.	Placebo n=29 Participants Participants will receive injections of placebo from Week 0 (baseline) to Week 16 (end of treatment). LEO 138559 placebo: LEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except for the medical ingredient LEO 138559.	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38.1 years STANDARD_DEVIATION 12.1 • n=5 Participants	32.8 years STANDARD_DEVIATION 10.2 • n=7 Participants	35.4 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Poland	16 participants n=5 Participants	19 participants n=7 Participants	35 participants n=5 Participants
Region of Enrollment Germany	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
EASI	26.93 units on a scale STANDARD_DEVIATION 11.77 • n=5 Participants	26.12 units on a scale STANDARD_DEVIATION 9.80 • n=7 Participants	26.53 units on a scale STANDARD_DEVIATION 10.74 • n=5 Participants
Baseline disease severity Baseline EASI score <21	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Baseline disease severity Baseline EASI score ≥21	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 0 to Week 16

Outcome measures

Outcome measures
Measure	LEO 138559 n=29 Participants Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment). LEO 138559: LEO 138559 is an antibody given by injection just under the skin.	Placebo n=29 Participants Participants will receive injections of placebo from Week 0 (baseline) to Week 16 (end of treatment). LEO 138559 placebo: LEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except for the medical ingredient LEO 138559.
Change in EASI Score From Baseline to Week 16	-15.3 score on a scale Standard Error 2.64	-3.5 score on a scale Standard Error 2.91

SECONDARY outcome

Timeframe: Week 0 to Week 16

Outcome measures

Outcome measures
Measure	LEO 138559 n=29 Participants Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment). LEO 138559: LEO 138559 is an antibody given by injection just under the skin.	Placebo n=29 Participants Participants will receive injections of placebo from Week 0 (baseline) to Week 16 (end of treatment). LEO 138559 placebo: LEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except for the medical ingredient LEO 138559.
Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject	40 adverse events	26 adverse events

Adverse Events

LEO 138559

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Disclosure Specialist

LEO Pharma A/S

Phone: +4544945888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee LEO Pharma seeks publication of all Phase 3 clinical trials in peer-reviewed journals within 18 months of trial completion, regardless of whether the findings are positive or negative. If there is no multi-centre publication within 18 months after the clinical trial has been completed or terminated at all trial sites, the investigator has the right to publish the results from the clinical trial generated by the investigator.
Publication restrictions are in place

Restriction type: OTHER

Measure	LEO 138559 n=29 participants at risk LEO 138559 (N=29)	Placebo n=29 participants at risk Placebo (N=29)
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Gastrointestinal disorders Gastrooesophageal reflux disease	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Gastrointestinal disorders Nausea	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Gastrointestinal disorders Oral pain	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Gastrointestinal disorders Vomiting	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	3.4% 1/29 • Number of events 2 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
General disorders Fatigue	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	6.9% 2/29 • Number of events 3 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
General disorders Inflammation	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
General disorders Influenza like illness	3.4% 1/29 • Number of events 3 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
General disorders Injection site reaction	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
General disorders Pyrexia	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Infections and infestations COVID-19	20.7% 6/29 • Number of events 6 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	6.9% 2/29 • Number of events 2 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Infections and infestations Conjunctivitis	6.9% 2/29 • Number of events 2 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Infections and infestations Coronavirus infection	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Infections and infestations Cystitis	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Infections and infestations Eczema herpeticum	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Infections and infestations Erysipelas	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Infections and infestations Impetigo	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Infections and infestations Nasopharyngitis	10.3% 3/29 • Number of events 3 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	10.3% 3/29 • Number of events 3 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Infections and infestations Rhinitis	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Infections and infestations Sinusitis	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Infections and infestations Upper respiratory tract infection	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	17.2% 5/29 • Number of events 6 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Injury, poisoning and procedural complications Head injury	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Injury, poisoning and procedural complications Vaccination complication	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Musculoskeletal and connective tissue disorders Arthralgia	6.9% 2/29 • Number of events 4 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Musculoskeletal and connective tissue disorders Spinal pain	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Nervous system disorders Burning sensation	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Nervous system disorders Headache	6.9% 2/29 • Number of events 2 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Nervous system disorders Syncope	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Psychiatric disorders Depression	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Renal and urinary disorders Renal pain	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Respiratory, thoracic and mediastinal disorders Haemoptysis	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Skin and subcutaneous tissue disorders Dermatitis	3.4% 1/29 • Number of events 2 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Skin and subcutaneous tissue disorders Dermatitis acneiform	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Skin and subcutaneous tissue disorders Dermatitis atopic	13.8% 4/29 • Number of events 5 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	13.8% 4/29 • Number of events 4 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Skin and subcutaneous tissue disorders Eczema	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/29 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)
Skin and subcutaneous tissue disorders Urticaria	6.9% 2/29 • Number of events 2 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)	3.4% 1/29 • Number of events 1 • 32 weeks (Treatment period: Week 0 to Week 16; Safety follow-up period: Week 16 to Week 32)