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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003615-22 | EudraCT Number |
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Terminated due to recruitment challenges.
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This was a double-blind, multi-centre, randomised, vehicle-controlled, within-subject phase 2a trial. The trial was designed to establish the efficacy and safety of delgocitinib cream in the treatment of adult subjects with discoid lupus erythematosus (DLE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delgocitinib cream 20 mg/g | Experimental | Delgocitinib cream applied twice daily for 6 weeks |
|
| Delgocitinib cream vehicle | Placebo Comparator | Delgocitinib cream vehicle applied twice daily for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delgocitinib cream | Drug | Cream for topical application. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesions With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 6. | 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. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs) up to Week 6. | Number of AEs from baseline to Week 6 | Week 0 to Week 6 |
| Number of Subjects With AEs up to Week 6. | Number of subjects with AEs from baseline to Week 6 |
Not provided
Main Inclusion Criteria:
Main Exclusion Criteria:
Target lesion dyspigmentation score of 2 at screening or baseline.
Target lesion scarring/atrophy score of 2 at screening or baseline.
Target lesion scarring alopecia score of >0 in scalp lesions at screening or baseline.
Medical history of systemic lupus erythematosus (SLE) with clinically significant organ involvement (American College of Rheumatology SLE classification criteria no. 6 to 9) including SLE-related pleuritis or pericarditis (by clinical evaluation and electrocardiogram), and neurologic, renal, and/or other major SLE-related organ system involvement. SLE joint involvement was acceptable.
Subjects with unstable or significant SLE disease activity findings that would, by its progressive nature and/or severity, interfere with the trial evaluation, completion, and/or procedures per the investigator's discretion.
Other skin conditions at screening or baseline that would interfere with the evaluation of DLE.
Immunosuppressive/immunomodulating therapy with e.g. methotrexate, cyclosporine, azathioprine, retinoids (both topical and systemic), or dapsone within 4 weeks prior to baseline.
Systemic prednisolone >7.5 mg/day or changed dose within 4 weeks prior to baseline (nasal and inhaled corticosteroids were allowed).
Treatment with the following medications:
Treatment with topical corticosteroids, calcineurin inhibitors, and phosphodiesterase-4 (PDE-4) inhibitors within 2 weeks prior to baseline.
Use of systemic antibiotics or cutaneously applied antibiotics on the target lesions within 2 weeks prior to baseline.
Ultraviolet (UV) therapy within 2 weeks prior to baseline.
Any procedure impairing the skin barrier (e.g. incision) within 2 cm from the border of any of the target lesions within 4 weeks prior to baseline.
Receipt of live (attenuated) vaccines within 4 weeks prior to baseline.
Treatment with any marketed biological therapy or investigational biologic agents:
Unstable or fluctuating use of tobacco within 1 month prior to screening which, in the opinion of the investigator, could affect the natural course of the disease and thus affect the evaluation of the treatment.
History of any active skin infection within 1 week prior to baseline.
Clinically significant infection within 4 weeks prior to baseline which, in the opinion of the investigator, could compromise the safety of the subject in the trial, interfere with evaluation of the IMP, or reduce the subject's ability to participate in the trial. Clinically significant infections are defined as:
Tuberculosis requiring treatment within 12 months prior to screening and/or subjects with a positive blood test for tuberculosis at screening. Subjects with high risk of latent tuberculosis (e.g. prior residence in or travel to countries with high prevalence of tuberculosis, close contact with a person with active tuberculosis, or a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed) must have been tested at screening.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEO Pharma Investigational Site | San Diego | California | 92103 | United States | ||
| LEO Pharma Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33687069 | Derived | Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2. |
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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.
37 subjects screened. 27 subjects randomised. 26 subjects completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 22, 2019 |
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This was a phase 2a, within-subject trial design, where all subjects were treated with active treatment on one DLE target lesion and vehicle treatment on another DLE target lesion.
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| Delgocitinib cream vehicle | Drug | The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient. |
|
|
| Week 0 to Week 6 |
| Number of Lesion-specific, Treatment-related AEs up to Week 6. | 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). | Week 0 to Week 6 |
| Number of Lesions With ≥2-point Reduction in IGA Score at Week 6 Compared to Baseline. | 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. | Week 0 to Week 6 |
| Number of Lesions With ≥2-point Reduction in Erythema Score at Week 6 Compared to Baseline. | 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. | Week 0 to Week 6 |
| Erythema Score at Week 6. | 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. | Week 6 |
| Total Skin Disease Activity Score (Sum of Scores for Erythema, Scaling/Hyperkeratosis, and Oedema/Infiltration) at 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. | Week 6 |
| Skokie |
| Illinois |
| 60077 |
| United States |
| LEO Pharma Investigational Site | Boston | Massachusetts | 02115 | United States |
| LEO Pharma Investigational Site | Forest Hills | New York | 11375 | United States |
| LEO Pharma Investigational Site | Cincinnati | Ohio | 45219 | United States |
| LEO Pharma Investigational Site | Aarhus | 8200 | Denmark |
| LEO Pharma Investigational site | Hellerup | 2900 | Denmark |
| LEO Pharma Investigational Site | Odense | 5000 | Denmark |
| LEO Pharma Investigational Site | Loiré | 42000 | France |
| LEO Pharma Investigational Site | Nice | 06202 | France |
| LEO Pharma Investigational Site | Paris | 75010 | France |
| LEO Pharma Investigational Site | Toulouse | 31000 | France |
| LEO Pharma Investigational Site | Aachen | 52074 | Germany |
| LEO Pharma Investigational Site | Berlin | 10117 | Germany |
| LEO Pharma Investigational Site | Bochum | 44791 | Germany |
| LEO Pharma Investigational Site | Dresden | 01307 | Germany |
| LEO Pharma Investigational Site | Düsseldorf | 40225 | Germany |
| LEO Pharma Investigational Site | Erlangen | 91054 | Germany |
| LEO Pharma Investigational Site | Oldenburg | 26133 | Germany |
| Lesions Treated With Delgocitinib Cream | All subjects had one target lesion treated with delgocitinib cream |
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| Lesions Treated With Delgocitinib Cream Vehicle | All subjects had one target lesion treated with delgocitinib cream vehicle |
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| COMPLETED |
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| NOT COMPLETED |
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Randomised subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomised Subjects | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Investigator's Global Assessment (IGA) of lesions to be treated with delgocitinib cream | 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. | Number | percentage of lesions |
| ||||||||||||||||||||||
| Investigator's Global Assessment (IGA) of lesions to be treated with vehicle | 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. | Number | percentage of lesions |
| ||||||||||||||||||||||
| Baseline erythema score of lesions to be treated with delgocitinib cream | 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. | Number | percentage of lesions |
| ||||||||||||||||||||||
| Baseline erythema score of lesions to be treated with vehicle | 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. | Number | percentage of lesions |
| ||||||||||||||||||||||
| Total skin disease activity score of lesions to be treated with delgocitinib cream | The total skin disease activity score is defined as the sum of the investigator assessed scores for 3 clinical signs (erythema, scaling/hyperkeratosis, oedema/infiltration) of a lesion. Erythema is scored on a 4-point scale 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), and oedema/infiltration is scored on a 3-point scale from 0 (absent) to 2 (palpable and visible). The total skin disease activity score ranges from 0 to 7. Higher scores indicate more severe symptoms. | Median | Inter-Quartile Range | scores on a scale |
| |||||||||||||||||||||
| Total skin disease activity score of lesions to be treated with vehicle | The total skin disease activity score is defined as the sum of the investigator assessed scores for 3 clinical signs (erythema, scaling/hyperkeratosis, oedema/infiltration) of a lesion. Erythema is scored on a 4-point scale 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), and oedema/infiltration is scored on a 3-point scale from 0 (absent) to 2 (palpable and visible). The total skin disease activity score ranges from 0 to 7. Higher scores indicate more severe symptoms. | Median | Inter-Quartile Range | scores on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Target Lesions With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 6. | 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. | 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. | Posted | Number | lesions | Week 6 |
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| Secondary | Number of Adverse Events (AEs) up to Week 6. | Number of AEs from baseline to Week 6 | 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. | Posted | Number | AEs | Week 0 to Week 6 |
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| Secondary | Number of Subjects With AEs up to Week 6. | Number of subjects with AEs from baseline to Week 6 | 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. | Posted | Count of Participants | Participants | Week 0 to Week 6 |
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| Secondary | Number of Lesion-specific, Treatment-related AEs up to Week 6. | 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). | 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. | Posted | Number | AEs | Week 0 to Week 6 |
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| Secondary | Number of Lesions With ≥2-point Reduction in IGA Score at Week 6 Compared to Baseline. | 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. | 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. | Posted | Number | lesions | Week 0 to Week 6 |
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| Secondary | Number of Lesions With ≥2-point Reduction in Erythema Score at Week 6 Compared to Baseline. | 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. | 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. | Posted | Number | lesions | Week 0 to Week 6 |
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| Secondary | Erythema Score at Week 6. | 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. | Per protocol (PP) analysis set. | Posted | Median | Inter-Quartile Range | scores on a scale | Week 6 |
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| Secondary | Total Skin Disease Activity Score (Sum of Scores for Erythema, Scaling/Hyperkeratosis, and Oedema/Infiltration) at 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. | 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. | Posted | Median | Inter-Quartile Range | scores on a scale | Week 6 |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | 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. | 0 | 27 | 0 | 27 | 10 | 27 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Cutaneous lupus erythematosus | Skin and subcutaneous tissue disorders | Non-systematic Assessment | This lesion-specific AE was assessed as probably related to delgocitinib cream, and the lesion was recovered/resolved from this AE. The subject was withdrawn from the trial due to this AE. |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Middle ear inflammation | Ear and labyrinth disorders | Non-systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | Non-systematic Assessment |
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| Application site pain | General disorders | Non-systematic Assessment | This lesion-specific AE was assessed as possibly related to delgocitinib cream, and the lesion was recovered/resolved from this AE. |
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| Application site pruritus | General disorders | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
|
The trial was terminated prematurely due to slow recruitment, and due to an anticipation that recruitment would become further delayed due to the COVID-19 pandemic affecting recruitment activities. The total number of subjects included in the trial therefore ended with 27 subjects randomised. 26 subjects completed the trial, as 1 subject withdrew from the trial due to an AE (moderate cutaneous lupus erythematosus [CLE]; reported term: cutaneous lupus erythematosus flare).
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure | LEO Pharma A/S | +45 4494 5888 | disclosure@leo-pharma.com |
| Apr 21, 2021 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008179 | Lupus Erythematosus, Discoid |
| ID | Term |
|---|---|
| D008178 | Lupus Erythematosus, Cutaneous |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| Unknown or Not Reported |
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| Other |
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| Unknown or Not Reported |
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| France |
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| Germany |
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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. |
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