Clinical trial NCT02118792: Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic Dermatitis
Official title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dermatitis, Atopic
Keywords: atopic dermatitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 764
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and efficacy of AN2728 Topical Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic dermatitis.


Eligibility criteria: Inclusion Criteria:

* Males or females 2 years and older
* Has a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka
* Has AD involvement ≥ 5% Treatable %BSA (excluding the scalp)
* Has an ISGA score of Mild (2) or Moderate (3) at Baseline/Day 1
* All female subjects of childbearing potential must use acceptable methods of contraception from the Screening Visit continuously until 30 days after stopping study drug

Exclusion Criteria:

* As determined by the study doctor, a medical history that may interfere with study objectives
* Unstable AD or any consistent requirement for high potency topical corticosteroids
* History of use of biologic therapy (including intravenous immunoglobulin)
* Recent or anticipated concomitant use of systemic or topical therapies that might alter the course of AD
* Recent or current participation in another research study
* Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study
* Participation in a previous AN2728 clinical trial

Primary outcomes:
measure: Percentage of Participants Who Achieved Success in Investigator's Static Global Assessment (ISGA) Score at Day 29
timeFrame: Day 29
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
timeFrame: AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36
measure: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings at Day 8
timeFrame: Baseline, Day 8
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 36
timeFrame: Baseline (Day 1), Day 36
measure: Number of Participants With Clinically Significant Laboratory Values
timeFrame: Baseline up to Day 36
measure: Percentage of Participants With Local Tolerability Symptoms at Baseline
timeFrame: Baseline (Day 1)
measure: Percentage of Participants With Local Tolerability Symptoms at Day 8
timeFrame: Day 8
measure: Percentage of Participants With Local Tolerability Symptoms at Day 15
timeFrame: Day 15
measure: Percentage of Participants With Local Tolerability Symptoms at Day 22
timeFrame: Day 22
measure: Percentage of Participants With Local Tolerability Symptoms at Day 29
timeFrame: Day 29
measure: Percentage of Participants With Local Tolerability Symptoms at Day 36
timeFrame: Day 36
Secondary outcomes:
measure: Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 29
timeFrame: Day 29
measure: Time to Achieve Treatment Success Based on Investigator's Static Global Assessment (ISGA)
timeFrame: Baseline up to Day 29
measure: Change From Baseline in Signs of Atopic Dermatitis at Day 29
timeFrame: Baseline, Day 29
Other outcomes:
measure: Time to Improvement in Pruritus
timeFrame: Baseline (Day 1) up to Day 29
measure: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Day 29
timeFrame: Baseline (Day 1), Day 29
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Day 29
timeFrame: Baseline (Day 1), Day 29
measure: Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score at Day 29
timeFrame: Baseline (Day 1), Day 29
Locations:
city: Henrico
country: United States
facility: Anacor Investigational Site
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Luger TA, Hebert AA, Zaenglein AL, Silverberg JI, Tan H, Ports WC, Zielinski MA. Subgroup Analysis of Crisaborole for Mild-to-Moderate Atopic Dermatitis in Children Aged 2 to < 18 Years. Paediatr Drugs. 2022 Mar;24(2):175-183. doi: 10.1007/s40272-021-00490-y. Epub 2022 Mar 16.
citation: Geng B, Hebert AA, Takiya L, Miller L, Werth JL, Zang C, Sanders P, Lebwohl MG. Efficacy and Safety Trends with Continuous, Long-Term Crisaborole Use in Patients Aged >/= 2 Years with Mild-to-Moderate Atopic Dermatitis. Dermatol Ther (Heidelb). 2021 Oct;11(5):1667-1678. doi: 10.1007/s13555-021-00584-y. Epub 2021 Aug 11.
citation: Thyssen JP, Zang C, Neary MP, Bushmakin AG, Cappelleri JC, Cha A, Russo C, Luger TA. Translating the Investigator's Static Global Assessment to the Eczema Area and Severity Index in Studies of Crisaborole for Atopic Dermatitis. Dermatol Ther (Heidelb). 2021 Jun;11(3):845-853. doi: 10.1007/s13555-021-00509-9. Epub 2021 Mar 13.
citation: Stein Gold LF, Takiya L, Zang C, Sanders P, Feldman SR. Demographics and Baseline Disease Characteristics of Early Responders to Crisaborole for Atopic Dermatitis. J Drugs Dermatol. 2020 Jun 1;19(6):619-624.
citation: Silverberg JI, Tallman AM, Ports WC, Gerber RA, Tan H, Zielinski MA. Evaluating the Efficacy of Crisaborole Using the Atopic Dermatitis Severity Index and Percentage of Affected Body Surface Area. Acta Derm Venereol. 2020 Jun 11;100(13):adv00170. doi: 10.2340/00015555-3489.
citation: Simpson EL, Paller AS, Boguniewicz M, Eichenfield LF, Feldman SR, Silverberg JI, Chamlin SL, Zane LT. Crisaborole Ointment Improves Quality of Life of Patients with Mild to Moderate Atopic Dermatitis and Their Families. Dermatol Ther (Heidelb). 2018 Dec;8(4):605-619. doi: 10.1007/s13555-018-0263-0. Epub 2018 Oct 22.
citation: Paller AS, Tom WL, Lebwohl MG, Blumenthal RL, Boguniewicz M, Call RS, Eichenfield LF, Forsha DW, Rees WC, Simpson EL, Spellman MC, Stein Gold LF, Zaenglein AL, Hughes MH, Zane LT, Hebert AA. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016 Sep;75(3):494-503.e6. doi: 10.1016/j.jaad.2016.05.046. Epub 2016 Jul 11.