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Terminated (This decision was made for business reasons only and is not related to any safety concerns regarding crisaborole.)
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This study is a Phase 3, multicenter, open-label, long-term safety extension study of Studies C3291032 and C3291031 in Japanese pediatric and adult participants with mild to moderate Atopic Dermatitis (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crisaborole 2% | Experimental | Crisaborole 2% ointment applied twice daily (BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crisaborole 2% | Drug | Crisaborole 2% ointment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse events (AE) is any untoward medical occurrence in clinical investigation participant administered a product or medical device; event need not necessarily to had a causal relationship with treatment or usage. SAEs: an AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to 28 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. | Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirao Clinic of Pediatrics and Pediatric Allergy | Hiroshima | Hiroshima | 734-0023 | Japan | ||
| Chitose dermatology and plastic surgery clinic |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years | Participants aged < 18 years with mild to moderate atopic dermatitis (AD) received crisaborole ointment, 2 percent (%) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug. |
| 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 | Yes | No | No | Study Protocol | May 20, 2020 | Jun 14, 2021 |
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| Chitose Shi |
| Hokkaido |
| 066-0021 |
| Japan |
| Takagi Dermatological Clinic | Obihiro | Hokkaido | 080-0013 | Japan |
| Yoshimura Child Clinic | Akashi | Hyōgo | 674-0068 | Japan |
| Iryouhoujinshadan Yamayurikai Tsujino. Kodomo Clinic | Kobe | Hyōgo | 658-0082 | Japan |
| Noguchi Dermatology Clinic | Kamimashiki-gun | Kumamoto | 861-3101 | Japan |
| Yoshioka Dermatology Clinic | Neyagawa | Osaka | 572-0838 | Japan |
| Mildix Skin Clinic | Adachi-ku | Tokyo | 120-0034 | Japan |
| Yoga Allergy Clinic | Setagaya-ku | Tokyo | 158-0097 | Japan |
| Sugamo Kobayashi Derma Clinic | Toshima-Ku | Tokyo | 170-0002 | Japan |
| Hoshikuma Dermatology・Allergy Clinic | Fukuoka | 814-0171 | Japan |
| FG001 | Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years | Participants aged >= 18 years with mild to moderate atopic dermatitis (AD) received crisaborole ointment, 2 percent (%) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug. |
| Completed Follow up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all participants who took at least 1 dose of study drug. Participants who entered the first Off-Treatment cycle were included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years | Participants aged < 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug. |
| BG001 | Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years | Participants aged >= 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 (NIH/OMB) | 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 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse events (AE) is any untoward medical occurrence in clinical investigation participant administered a product or medical device; event need not necessarily to had a causal relationship with treatment or usage. SAEs: an AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to 28 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. | Safety population included all participants who took at least 1 dose of study drug. Participants who entered the first Off-Treatment cycle were included. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks) |
|
|
|
Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
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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 | Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years | Participants aged < 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug. | 0 | 30 | 0 | 30 | 11 | 30 |
| EG001 | Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years | Participants aged >= 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Participants were followed up to at least 28 days after last dose of study drug. | 0 | 10 | 0 | 10 | 3 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Molluscum contagiosum | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
|
Participants were planned to be followed up to Week 56, however due to early termination of the study, participants were followed up to only Week 12.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 7, 2021 | Jun 14, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| 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 |
|
| Unknown or Not Reported |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|