A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04498403
• Collaborator: (none)
• Enrollment: 40
• Locations: 11
• Arm: 1
• Actual Duration (Months): 3.1
• Patients Per Site: 3.6
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Crisaborole 2%	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A PHASE 3, MULTICENTER, OPEN-LABEL STUDY OF THE LONG-TERM SAFETY OF CRISABOROLE OINTMENT, 2% IN JAPANESE PEDIATRIC AND ADULT PARTICIPANTS WITH MILD TO MODERATE ATOPIC DERMATITIS
• Actual Study Start Date: Sep 14, 2020
• Actual Primary Completion Date: Dec 18, 2020
• Actual Study Completion Date: Dec 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Crisaborole 2% Crisaborole 2% ointment applied twice daily (BID)	Drug: Crisaborole 2%; Crisaborole 2% ointment

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Months and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female participants;

• Who were patients with mild to moderate AD aged 2 years old or older and met eligibility criteria for study C3291032 at the time when entering Study C3291032, and completed treatment period in Study C3291032 without safety issues. Or

• Who were patients with mild to moderate AD aged 1 months to <24 months and met eligibility criteria for Study C3291031 at the time when entering Study C3291031, and completed treatment period in Study C3291031 without safety issues

Exclusion Criteria:

• Has other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shirao Clinic of Pediatrics and Pediatric Allergy	Hiroshima-shi	Hiroshima	Japan	734-0023
2	Chitose dermatology and plastic surgery clinic	Chitose Shi	Hokkaido	Japan	066-0021
3	Takagi Dermatological Clinic	Obihiro	Hokkaido	Japan	080-0013
4	Yoshimura Child Clinic	Akashi-City	Hyōgo	Japan	674-0068
5	Iryouhoujinshadan Yamayurikai Tsujino. Kodomo Clinic	Kobe-City	Hyōgo	Japan	658-0082
6	Noguchi Dermatology Clinic	Kamimashiki-gun	Kumamoto	Japan	861-3101
7	Yoshioka Dermatology Clinic	Neyagawa	Osaka	Japan	572-0838
8	Mildix Skin Clinic	Adachi-ku	Tokyo	Japan	120-0034
9	Yoga Allergy Clinic	Setagaya-ku	Tokyo	Japan	158-0097
10	Sugamo Kobayashi Derma Clinic	Toshima-Ku	Tokyo	Japan	170-0002
11	Hoshikuma Dermatology・Allergy Clinic	Fukuoka		Japan	814-0171

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - May 20, 2020
• Statistical Analysis Plan - Jan 7, 2021

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04498403
• Other Study ID Numbers: C3291027
• First Posted: Aug 4, 2020
• Last Update Posted: Aug 12, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: Eczema; Crisaborole
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema

Study Results

Participant Flow

Arm/Group Title	Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years	Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	30	10
Completed Follow up	30	10
COMPLETED	0	0
NOT COMPLETED	30	10

Baseline Characteristics

Arm/Group Title	Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years	Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	30	10	40
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	9.3 (3.99)	31.8 (7.97)	15.0 (11.11)
Sex: Female, Male (Count of Participants)
Female	15 50%	4 40%	19 47.5%
Male	15 50%	6 60%	21 52.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	30 100%	10 100%	40 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	30 100%	10 100%	40 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description	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.
Time Frame	Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)

Outcome Measure Data

Analysis Population Description

Safety population included all participants who took at least 1 dose of study drug. Participants who entered the first Off-Treatment cycle were included.

Arm/Group Title	Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years	Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
Arm/Group Description	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.	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.
Measure Participants	30	10
TEAEs	11 36.7%	3 30%
SAEs	0 0%	0 0%

Adverse Events

Time Frame	Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
Arm/Group Title	Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years		Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
Arm/Group Description	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.		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.
All Cause Mortality
	Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years		Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/10 (0%)
Serious Adverse Events
	Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years		Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Cohort 1: Crisaborole 2%, Age Group: Less Than (<) 18 Years		Cohort 2: Crisaborole 2%, Age Group: Greater Than or Equal to (>=) 18 Years
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/30 (36.7%)		3/10 (30%)
General disorders
Application site pain	1/30 (3.3%)		0/10 (0%)
Infections and infestations
Bronchitis	1/30 (3.3%)		0/10 (0%)
Gastroenteritis	0/30 (0%)		1/10 (10%)
Molluscum contagiosum	1/30 (3.3%)		0/10 (0%)
Nasopharyngitis	3/30 (10%)		0/10 (0%)
Otitis media acute	1/30 (3.3%)		0/10 (0%)
Rhinitis	1/30 (3.3%)		0/10 (0%)
Injury, poisoning and procedural complications
Wound	0/30 (0%)		1/10 (10%)
Musculoskeletal and connective tissue disorders
Joint effusion	0/30 (0%)		1/10 (10%)
Skin and subcutaneous tissue disorders
Acne	1/30 (3.3%)		0/10 (0%)
Dermatitis atopic	2/30 (6.7%)		0/10 (0%)
Dermatitis contact	1/30 (3.3%)		0/10 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.