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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delgocitinib cream 1 mg/g | Experimental | Delgocitinib cream applied twice daily for 8 weeks |
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| Delgocitinib cream 3 mg/g | Experimental | Delgocitinib cream applied twice daily for 8 weeks |
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| Delgocitinib cream 8 mg/g | Experimental | Delgocitinib cream applied twice daily for 8 weeks |
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| Delgocitinib cream 20 mg/g | Experimental | Delgocitinib cream applied twice daily for 8 weeks |
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| Delgocitinib cream vehicle | Placebo Comparator | Delgocitinib cream vehicle applied twice daily for 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delgocitinib cream | Drug | Cream for topical application |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | vIGA-AD is an instrument used in clinical trials to assess the subject's global disease severity and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose-selection. Cochran-Mantel-Haenszel analysis was used to determine the difference in response rates between the active delgocitinib cream doses and the delgocitinib cream vehicle. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leo Pharma Investigational Site | Birmingham | Alabama | 35209 | United States | ||
| Leo Pharma Investigational Site |
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326 participants were screened for this trial. Of these, 75 participants (23.0%) were screening failures. The main reason for screening failure was failure to meet eligibility criteria (18.4%).
251 participants from 31 sites in 3 countries (U.S., Canada and Australia) were randomised in this trial. The first participant was screened on 29-Nov-2018 and the last participant completed the trial on 19-May-2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delgocitinib Cream 1 mg/g | Delgocitinib cream applied twice daily for 8 weeks Delgocitinib cream: Cream for topical application |
| FG001 | Delgocitinib Cream 3 mg/g | Delgocitinib cream applied twice daily for 8 weeks Delgocitinib cream: Cream for topical application |
| 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 | Aug 22, 2019 |
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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. |
|
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| Week 0 to Week 8 |
| EASI75 at Week 8 | EASI75 is defined as at least 75% reduction in EASI from baseline. | Week 0 to Week 8 |
| Time to vIGA-AD TS | The time to vIGA-AD TS response is defined as the time from baseline to first assessment of a vIGA-AD score of 0 (Clear) or 1 (Almost Clear) with ≥2-step improvement | Week 0 to Week 8 |
| Encino |
| California |
| 91436 |
| United States |
| Leo Pharma Investigational Site | Los Angeles | California | 90033 | United States |
| Leo Pharma Investigational Site | Los Angeles | California | 90045 | United States |
| Leo Pharma Investigational Site | Rolling Hills Estates | California | 90274-7604 | United States |
| Leo Pharma Investigational Site | Santa Ana | California | 92701 | United States |
| Leo Pharma Investigational Site | Chicago | Illinois | 60611 | United States |
| Leo Pharma Investigational Site | Detroit | Michigan | 48202 | United States |
| Leo Pharma Investigational Site | New York | New York | 10019 | United States |
| Leo Pharma Investigational Site | High Point | North Carolina | 27262 | United States |
| Leo Pharma Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Leo Pharma Investigational Site | Carlton | 3053 | Australia |
| Leo Pharma Investigational Site | Darlinghurst | 2010 | Australia |
| Leo Pharma Investigational Site | East Melbourne | 3002 | Australia |
| Leo Pharma Investigational Site | Hectorville | 5073 | Australia |
| Leo Pharma Investigational Site 1 | Kogarah | 2217 | Australia |
| Leo Pharma Investigational Site | Kogarah | 2217 | Australia |
| Leo Pharma Investigational Site | Woolloongabba | 4102 | Australia |
| Leo Pharma Investigational Site | Calgary | Alberta | T3A 2N1 | Canada |
| Leo Pharma Investigational Site | Edmonton | Alberta | T5K 1X3 | Canada |
| Leo Pharma Investigational Site | Surrey | British Columbia | V3R 6A7 | Canada |
| Leo Pharma Investigational Site | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Leo Pharma Investigational Site | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Leo Pharma Investigational Site | Mississauga | Ontaria | L5H 1G9 | Canada |
| Leo Pharma Investigational Site | Barrie | Ontario | L4M 7G1 | Canada |
| Leo Pharma Investigational Site | Markham | Ontario | L3P 1X2 | Canada |
| Leo Pharma Investigational Site | Peterborough | Ontario | K9J 5K2 | Canada |
| Leo Pharma Investigational Site | Richmond Hill | Ontario | L4C 9M7 | Canada |
| Leo Pharma Investigational Site | Toronto | Ontario | M2M 4J5 | Canada |
| Leo Pharma Investigational Site | Toronto | Ontario | M2W 2N2 | Canada |
| Leo Pharma Investigational Site | Toronto | Ontario | M3H 5Y8 | Canada |
| FG002 | Delgocitinib Cream 8 mg/g | Delgocitinib cream applied twice daily for 8 weeks Delgocitinib cream: Cream for topical application |
| FG003 | Delgocitinib Cream 20 mg/g | Delgocitinib cream applied twice daily for 8 weeks Delgocitinib cream: Cream for topical application |
| FG004 | Delgocitinib Cream Vehicle | Delgocitinib cream vehicle applied twice daily for 8 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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| COMPLETED |
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| NOT COMPLETED |
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Number of subjects randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | Delgocitinib Cream 1 mg/g | Delgocitinib cream applied twice daily for 8 weeks Delgocitinib cream: Cream for topical application |
| BG001 | Delgocitinib Cream 3 mg/g | Delgocitinib cream applied twice daily for 8 weeks Delgocitinib cream: Cream for topical application |
| BG002 | Delgocitinib Cream 8 mg/g | Delgocitinib cream applied twice daily for 8 weeks Delgocitinib cream: Cream for topical application |
| BG003 | Delgocitinib Cream 20 mg/g | Delgocitinib cream applied twice daily for 8 weeks Delgocitinib cream: Cream for topical application |
| BG004 | Delgocitinib Cream Vehicle | Delgocitinib cream vehicle applied twice daily for 8 weeks Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient. |
| BG005 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Baseline 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Baseline vIGA-AD score | vIGA-AD is an instrument used in clinical trials to assess the subject's global disease severity and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). | Count of Participants | Participants |
|
| 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 | 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. | FAS (defined as all randomized subjects exposed to investigational medicinal product) | Posted | Least Squares Mean | Standard Error | score on a scale | Week 0 to Week 8 |
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| Secondary | 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. | vIGA-AD is an instrument used in clinical trials to assess the subject's global disease severity and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose-selection. Cochran-Mantel-Haenszel analysis was used to determine the difference in response rates between the active delgocitinib cream doses and the delgocitinib cream vehicle. | FAS (defined as all randomized subjects exposed to investigational medicinal product). | Posted | Count of Participants | Participants | Week 0 to Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | EASI75 at Week 8 | EASI75 is defined as at least 75% reduction in EASI from baseline. | FAS (defined as all randomized subjects exposed to investigational medicinal product). | Posted | Count of Participants | Participants | Week 0 to Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to vIGA-AD TS | The time to vIGA-AD TS response is defined as the time from baseline to first assessment of a vIGA-AD score of 0 (Clear) or 1 (Almost Clear) with ≥2-step improvement | FAS (defined as all randomized subjects exposed to investigational medicinal product) | Posted | Median | Inter-Quartile Range | Days | Week 0 to Week 8 |
|
10 weeks (from first application of IMP up until the last visit (safety follow-up visit)).
Adverse events reported for all randomized subjects exposed to investigational medicinal product
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Delgocitinib Cream 1 mg/g | Delgocitinib cream applied twice daily for 8 weeks Delgocitinib cream: Cream for topical application | 0 | 49 | 1 | 49 | 12 | 49 |
| EG001 | Delgocitinib Cream 3 mg/g | Delgocitinib cream applied twice daily for 8 weeks Delgocitinib cream: Cream for topical application | 0 | 50 | 1 | 50 | 11 | 50 |
| EG002 | Delgocitinib Cream 8 mg/g | Delgocitinib cream applied twice daily for 8 weeks Delgocitinib cream: Cream for topical application | 0 | 50 | 0 | 50 | 8 | 50 |
| EG003 | Delgocitinib Cream 20 mg/g | Delgocitinib cream applied twice daily for 8 weeks Delgocitinib cream: Cream for topical application | 0 | 51 | 0 | 51 | 12 | 51 |
| EG004 | Delgocitinib Cream Vehicle | Delgocitinib cream vehicle applied twice daily for 8 weeks Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient. | 0 | 50 | 1 | 50 | 11 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Hypertonic bladder | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Dermatitis atopic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Application site pruritus | General disorders | Non-systematic Assessment |
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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. After such a publication is made public, or 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 |
| May 7, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| Asian |
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| Native Hawaiian or other Pacific islander |
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| American Indian or Alaska native |
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| Other |
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| United States |
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| Australia |
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| 1 - Almost clear |
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| 2 - Mild |
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| 3 - Moderate |
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| 4 - Severe |
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| Superiority |
| Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows: Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD. The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8. | Mixed Models Analysis | <0.01 | The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic. | Mean Difference (Net) | -3.1 | 2-Sided | 95 | -5.0 | -1.3 | Superiority |
| Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows: Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD. The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8. | Mixed Models Analysis | <0.05 | The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic. | Mean Difference (Net) | -3.0 | 2-Sided | 95 | -4.8 | -1.2 | Superiority |
| Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows: Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD. The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8. | Mixed Models Analysis | <0.0001 | The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic. | Mean Difference (Net) | -4.0 | 2-Sided | 95 | -5.8 | -2.1 | Superiority |
| Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows: Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD. The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8. | Mixed Models Analysis | <0.0001 | The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic. | Median Difference (Net) | -5.7 | 2-Sided | 95 | -7.5 | -3.9 | Superiority |
| OG003 | Delgocitinib Cream 20 mg/g | Delgocitinib cream applied twice daily for 8 weeks Delgocitinib cream: Cream for topical application |
| OG004 | Delgocitinib Cream Vehicle | Delgocitinib cream vehicle applied twice daily for 8 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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| Delgocitinib Cream Vehicle |
Delgocitinib cream vehicle applied twice daily for 8 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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| OG004 | Delgocitinib Cream Vehicle | Delgocitinib cream vehicle applied twice daily for 8 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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