Trial Outcomes & Findings for Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus. (NCT NCT03958955)

Last Updated: 2025-03-06

Results Overview

The IGA is an instrument used in clinical trials to rate the severity of the subject's global disease and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). In this trial, the IGA was a lesion-specific assessment and was evaluated separately for each of the 2 target lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Week 6

Results posted on

2025-03-06

Participant Flow

37 subjects screened. 27 subjects randomised. 26 subjects completed.

A screening visit took place 7 to 28 days before the first application of investigational medicinal product (IMP). To be eligible for participation in the trial each subject had to have at least 2 discoid lupus erythematosus (DLE) target lesions with active disease (referred to as lesions 1 and 2) fulfilling the inclusion criteria.

Participant milestones

Participant milestones
Measure	All Subjects All 27 subjects received delgocitinib cream 20 mg/g on one DLE target lesion and delgocitinib cream vehicle on another DLE target lesion twice daily for 6 weeks. Delgocitinib cream 20 mg/g: Cream for topical application. Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Overall Study STARTED	27
Overall Study Lesions Treated With Delgocitinib Cream	27
Overall Study Lesions Treated With Delgocitinib Cream Vehicle	27
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	All Subjects All 27 subjects received delgocitinib cream 20 mg/g on one DLE target lesion and delgocitinib cream vehicle on another DLE target lesion twice daily for 6 weeks. Delgocitinib cream 20 mg/g: Cream for topical application. Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Overall Study Adverse Event	1

Baseline Characteristics

Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Randomised Subjects n=27 Participants Randomised subjects received delgocitinib cream 20 mg/g on one DLE target lesion and delgocitinib cream vehicle on another DLE target lesion twice daily for 6 weeks. Delgocitinib cream 20 mg/g: Cream for topical application. Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Age, Continuous	45.7 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	20 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants
Region of Enrollment Denmark	1 participants n=5 Participants
Region of Enrollment France	5 participants n=5 Participants
Region of Enrollment Germany	17 participants n=5 Participants
Investigator's Global Assessment (IGA) of lesions to be treated with delgocitinib cream IGA score 3 (moderate)	88.9 percentage of lesions n=5 Participants
Investigator's Global Assessment (IGA) of lesions to be treated with delgocitinib cream IGA score 4 (severe)	11.1 percentage of lesions n=5 Participants
Investigator's Global Assessment (IGA) of lesions to be treated with vehicle IGA score 3 (moderate)	88.9 percentage of lesions n=5 Participants
Investigator's Global Assessment (IGA) of lesions to be treated with vehicle IGA score 4 (severe)	11.1 percentage of lesions n=5 Participants
Baseline erythema score of lesions to be treated with delgocitinib cream Erythema score 2	37.0 percentage of lesions n=5 Participants
Baseline erythema score of lesions to be treated with delgocitinib cream Erythema score 3	63.0 percentage of lesions n=5 Participants
Baseline erythema score of lesions to be treated with vehicle Erythema score 2	48.1 percentage of lesions n=5 Participants
Baseline erythema score of lesions to be treated with vehicle Erythema score 3	51.9 percentage of lesions n=5 Participants
Total skin disease activity score of lesions to be treated with delgocitinib cream	5.0 scores on a scale n=5 Participants
Total skin disease activity score of lesions to be treated with vehicle	5.0 scores on a scale n=5 Participants

PRIMARY outcome

Timeframe: Week 6

Population: Per protocol (PP) analysis set. 5 subjects were excluded from the per protocol (PP) analysis set as the primary endpoint data were compromised. The PP analysis set hence comprised 22 (81.5%) subjects. Data at Week 8 was excluded from the PP analysis set for 2 subjects, as they used prohibited concomitant medication in the safety follow-up period.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=22 Participants Delgocitinib cream applied twice daily for 6 weeks Delgocitinib cream: Cream for topical application.	Delgocitinib Cream Vehicle n=22 Participants Delgocitinib cream vehicle applied twice daily for 6 weeks Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Target Lesions With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 6.	3 lesions	6 lesions

SECONDARY outcome

Timeframe: Week 0 to Week 6

Population: Safety analysis set. All 27 subjects were exposed to IMP. All subjects were treated with delgocitinib cream on one target lesion and with vehicle on another target lesion, and except for lesion-specific AEs, it was therefore not possible to distinguish between AEs related to delgocitinib cream or vehicle treatment.

Number of AEs from baseline to Week 6

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=27 Participants Delgocitinib cream applied twice daily for 6 weeks Delgocitinib cream: Cream for topical application.	Delgocitinib Cream Vehicle Delgocitinib cream vehicle applied twice daily for 6 weeks Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Adverse Events (AEs) up to Week 6.	8 AEs	—

SECONDARY outcome

Timeframe: Week 0 to Week 6

Number of subjects with AEs from baseline to Week 6

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=27 Participants Delgocitinib cream applied twice daily for 6 weeks Delgocitinib cream: Cream for topical application.	Delgocitinib Cream Vehicle Delgocitinib cream vehicle applied twice daily for 6 weeks Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Subjects With AEs up to Week 6.	8 Participants	—

SECONDARY outcome

Timeframe: Week 0 to Week 6

Population: Safety analysis set. All 27 subjects were exposed to IMP. All subjects were treated with delgocitinib cream on one target lesion and with vehicle on another target lesion. It was therefore only possible to distinguish between AEs related to delgocitinib cream or vehicle treatment for the lesion-specific AEs.

The number of lesion-specific, treatment-related AEs per target lesion will be compared for active and vehicle treatment. Lesion-specific AEs are defined as lesional/perilesional AEs (i.e. AE location within the treatment area and/or ≤2 cm from the border of a target lesion).

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=27 Participants Delgocitinib cream applied twice daily for 6 weeks Delgocitinib cream: Cream for topical application.	Delgocitinib Cream Vehicle n=27 Participants Delgocitinib cream vehicle applied twice daily for 6 weeks Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Lesion-specific, Treatment-related AEs up to Week 6.	2 AEs	0 AEs

SECONDARY outcome

Timeframe: Week 0 to Week 6

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=22 Participants Delgocitinib cream applied twice daily for 6 weeks Delgocitinib cream: Cream for topical application.	Delgocitinib Cream Vehicle n=22 Participants Delgocitinib cream vehicle applied twice daily for 6 weeks Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Lesions With ≥2-point Reduction in IGA Score at Week 6 Compared to Baseline.	3 lesions	6 lesions

SECONDARY outcome

Timeframe: Week 0 to Week 6

The erythema score is lesion-specific and based on the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) and the Revised CLASI (RCLASI) which are validated scoring systems to assess disease activity and damage in patients with cutaneous lupus erythematosus. The severity of the erythema is scored on a 4-point scale ranging from 0 to 3. The severity is scored from low to high with 0=absent and 3=dark red, purple/violaceous/crusted/haemorrhagic.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=22 Participants Delgocitinib cream applied twice daily for 6 weeks Delgocitinib cream: Cream for topical application.	Delgocitinib Cream Vehicle n=22 Participants Delgocitinib cream vehicle applied twice daily for 6 weeks Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Lesions With ≥2-point Reduction in Erythema Score at Week 6 Compared to Baseline.	5 lesions	5 lesions

SECONDARY outcome

Timeframe: Week 6

Population: Per protocol (PP) analysis set.

The erythema score is lesion-specific and based on the CLASI and the RCLASI which are validated scoring systems to assess disease activity and damage in patients with cutaneous lupus erythematosus. The severity of the erythema is scored on a 4-point scale ranging from 0 to 3. The severity is scored from low to high with 0=absent and 3=dark red, purple/violaceous/crusted/haemorrhagic.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=22 Participants Delgocitinib cream applied twice daily for 6 weeks Delgocitinib cream: Cream for topical application.	Delgocitinib Cream Vehicle n=22 Participants Delgocitinib cream vehicle applied twice daily for 6 weeks Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Erythema Score at Week 6.	1.5 scores on a scale Interval 1.0 to 2.0	1.5 scores on a scale Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: Week 6

The skin disease activity scores are based on the CLASI and the RCLASI which are validated scoring systems to assess disease activity and damage in patients with cutaneous lupus erythematosus. The total skin disease activity score is defined as the sum of the scores for 3 clinical signs (erythema, scaling/hyperkeratosis, oedema/infiltration) for each target lesion. For the total score and the individual clinical signs, higher scores indicate more severe symptoms. Erythema is scored on a 4-point scale ranging from 0 (absent) to 3 (dark red, purple/violaceous/crusted/haemorrhagic). Hyperkeratosis/scaling is scored on a 3-point scale from 0 (absent) to 2 (verrucous hyperkeratosis). Oedema/infiltration is scored on a 3-point scale from 0 (absent) to 2 (palpable and visible). The total skin disease activity score can therefore range from 0 to 7.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=22 Participants Delgocitinib cream applied twice daily for 6 weeks Delgocitinib cream: Cream for topical application.	Delgocitinib Cream Vehicle n=22 Participants Delgocitinib cream vehicle applied twice daily for 6 weeks Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Total Skin Disease Activity Score (Sum of Scores for Erythema, Scaling/Hyperkeratosis, and Oedema/Infiltration) at Week 6.	2.5 scores on a scale Interval 2.0 to 4.0	2.5 scores on a scale Interval 1.0 to 4.0

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Subjects n=27 participants at risk All 27 subjects in the safety analysis set were treated with delgocitinib cream on one target lesion and with vehicle on another target lesion, and except for lesion-specific AEs, it was therefore not possible to distinguish between AEs related to delgocitinib cream or vehicle treatment. Delgocitinib cream 20 mg/g: Cream for topical application. Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Infections and infestations Nasopharyngitis	14.8% 4/27 • Number of events 5 • 8 weeks All 27 subjects in the safety analysis set were treated with delgocitinib cream on one target lesion and with vehicle on another target lesion, and except for lesion-specific AEs, it was therefore not possible to distinguish between AEs related to delgocitinib cream or vehicle treatment.
Skin and subcutaneous tissue disorders Cutaneous lupus erythematosus	3.7% 1/27 • Number of events 1 • 8 weeks All 27 subjects in the safety analysis set were treated with delgocitinib cream on one target lesion and with vehicle on another target lesion, and except for lesion-specific AEs, it was therefore not possible to distinguish between AEs related to delgocitinib cream or vehicle treatment.
Skin and subcutaneous tissue disorders Rash erythematous	3.7% 1/27 • Number of events 1 • 8 weeks All 27 subjects in the safety analysis set were treated with delgocitinib cream on one target lesion and with vehicle on another target lesion, and except for lesion-specific AEs, it was therefore not possible to distinguish between AEs related to delgocitinib cream or vehicle treatment.
Ear and labyrinth disorders Middle ear inflammation	3.7% 1/27 • Number of events 1 • 8 weeks All 27 subjects in the safety analysis set were treated with delgocitinib cream on one target lesion and with vehicle on another target lesion, and except for lesion-specific AEs, it was therefore not possible to distinguish between AEs related to delgocitinib cream or vehicle treatment.
Gastrointestinal disorders Gastrointestinal disorder	3.7% 1/27 • Number of events 1 • 8 weeks All 27 subjects in the safety analysis set were treated with delgocitinib cream on one target lesion and with vehicle on another target lesion, and except for lesion-specific AEs, it was therefore not possible to distinguish between AEs related to delgocitinib cream or vehicle treatment.
General disorders Application site pain	3.7% 1/27 • Number of events 2 • 8 weeks All 27 subjects in the safety analysis set were treated with delgocitinib cream on one target lesion and with vehicle on another target lesion, and except for lesion-specific AEs, it was therefore not possible to distinguish between AEs related to delgocitinib cream or vehicle treatment.
General disorders Application site pruritus	3.7% 1/27 • Number of events 1 • 8 weeks All 27 subjects in the safety analysis set were treated with delgocitinib cream on one target lesion and with vehicle on another target lesion, and except for lesion-specific AEs, it was therefore not possible to distinguish between AEs related to delgocitinib cream or vehicle treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.7% 1/27 • Number of events 1 • 8 weeks All 27 subjects in the safety analysis set were treated with delgocitinib cream on one target lesion and with vehicle on another target lesion, and except for lesion-specific AEs, it was therefore not possible to distinguish between AEs related to delgocitinib cream or vehicle treatment.
Nervous system disorders Headache	3.7% 1/27 • Number of events 1 • 8 weeks All 27 subjects in the safety analysis set were treated with delgocitinib cream on one target lesion and with vehicle on another target lesion, and except for lesion-specific AEs, it was therefore not possible to distinguish between AEs related to delgocitinib cream or vehicle treatment.

Additional Information

Clinical Disclosure

LEO Pharma A/S

Phone: +45 4494 5888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee LEO Pharma A/S seeks publication of all clinical trials in peer-reviewed journals within 18 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by LEO Pharma A/S within these 18 months, the investigator has the right to publish the results from the clinical trial generated by him/herself.
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Restriction type: OTHER