You are here

Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

Last updated on November 9, 2018

FOR MORE INFORMATION
Study Location
Forward Clinical Trials Inc.
Tampa, Florida, 33624 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dermatitis, Atopic Dermatitis, Eczema, Skin Diseases, Genetic Skin Diseases, Inborn Genetic Diseases, Eczematous Skin Diseases, Hypersensitivity, Immediate Hypersensitivity, Immune System Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subjects aged 18 years or older at the time of informed consent

- Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate
to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS
severity 4)

- Documented recent history (within 6 months before the screening visit) of inadequate
response to treatment with medicated topical therapy for AD for at least 4 weeks, or
who have required systemic therapies for control of their disease.

- Must be willing and able to comply with standardized background topical therapy, as
per protocol guidelines throughout the study

- Female subjects who are of childbearing potential must not be intending to become
pregnant, currently pregnant, or lactating. The following conditions apply:

1. Female subjects of childbearing potential must have a confirmed negative
pregnancy test prior to randomization;

2. Female subjects of childbearing potential must agree to use a highly effective
method of contraception for the duration of the active treatment period and for
at least 28 days after the last dose of investigational product.

- Female subjects of non-childbearing potential must meet at least 1 of the following
criteria:

- Have undergone a documented hysterectomy and/or bilateral oophorectomy;

- Have medically confirmed ovarian failure; or

- Achieved postmenopausal status, defined as follows: cessation of regular menses
for at least 12 consecutive months with no alternative pathological or
physiological cause and have a serum follicle stimulating hormone (FSH) level
confirming the postmenopausal state.

All other female subjects (including female subjects with tubal ligations) are considered
to be of childbearing potential.

-If receiving concomitant medications for any reason other than AD, must be on a stable
regimen prior to Day 1 and through the duration of the study

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study

- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q
wave interval abnormalities, current or history of certain infections, cancer,
lymphoproliferative disorders and other medical conditions at the discretion of the
investigator

- Unwilling to discontinue current AD medications prior to the study or require
treatment with prohibited medications during the study

- Other active nonAD inflammatory skin diseases or conditions affecting skin

- Prior treatment with JAK inhibitors

- Previous treatment with dupilumab

- Unwilling to discontinue current AD medications prior to the study or require
treatment with prohibited medications during the study

NCT03720470
Pfizer
Recruiting
Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Otitis Media, Myringotomy Tube Insertion, Skin Rash, Trauma
NCT01339546
All Genders
Psoriatic Arthritis, Psoriasis, Papulosquamous Skin Diseases
NCT00293709
All Genders
18+
Years
Muenchen,
Erectile Dysfunction, Cardiovascular Diseases, Male Urogenital Diseases
NCT01150903
Males
Intra-Abdominal Infections, Infectious Skin Disease, Soft Tissues Infections
NCT00827541
All Genders
Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
A Phase 3 Randomized, Double Blind, Double- Dummy, Placebo-controlled, Parallel Group, Multi-center Study Investigating The Efficacy And Safety Of Pf-04965842 And Dupilumab In Comparison With Placebo In Adult Subjects On Background Topical Therapy, With Moderate To Severe Atopic Dermatitis
B7451029 is a Phase 3 study to investigate PF-04965842 in adult patients who have moderate to severe atopic dermatitis and use background topical therapy. The efficacy of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily will be evaluated relative to placebo over 12 weeks. The efficacy of the two dosage strengths of PF-04965842 will be compared with dupilumab in terms of pruritus relief at 2 weeks. The two dosage strengths of PF-04965842 and dupilumab 300 mg injected subcutaneously once every two weeks (with a loading dose of 600 mg injected on the first day) will also be evaluated relative to placebo over 16 weeks. The safety of the investigational products will be evaluated over the duration of the study. Subjects will use non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, calcineurin inhibitors or PDE4 inhibitors, as per protocol guidance, to treat active lesions during the study. Subjects who are randomized to receive one of the two dosage strengths of PF-04965842 will also receive placebo injectable study drug every two weeks until Week 16 and then will continue on receiving only the oral study drug for 4 weeks. Subjects who are randomized to receive dupilumab injections every two weeks will also receive oral placebo to be taken once daily until Week 16 and will then continue to receive only the oral placebo for 4 weeks. Subjects who are randomized to the placebo arms, will receive both daily oral placebo and injectable placebo every two weeks until Week 16, after which they will receive either 100 mg or 200 mg of PF-04965842 taken orally once daily for 4 weeks, dependent upon which arm they have been allocated to. Eligible subjects will have an option to enter a long-term extension study after completing 20 weeks of treatment.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Dermatitis
  • Dermatitis, Atopic
  • Eczema
  • Skin Diseases
  • Skin Diseases, Genetic
  • Genetic Diseases, Inborn
  • Skin Diseases, Eczematous
  • Hypersensitivity
  • Hypersensitivity, Immediate
  • Immune System Diseases
  • Drug: PF-04965842 100 mg

    PF-04965842 100 mg, administered as two tablets to be taken orally once daily as follows:

    1. In the arm "PF-04965842 100 mg + Injectable Placebo followed by PF-04965842 100 mg," PF-04965842 100 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20;
    2. In the arm "Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842" subjects take PF-04965842 100 mg from Week 16 to Week 20.
  • Drug: PF-04965842 200 mg

    PF-04965842 200 mg, administered as two tablets to be taken orally once daily as follows:

    1. In the arm "PF-04965842 200 mg + Injectable Placebo followed by PF-04965842 100 mg," PF-04965842 200 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20;
    2. In the arm "Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842" subjects take PF-04965842 200 mg from Week 16 to Week 20.
  • Drug: Dupilumab
    Two subcutaneous injections of Dupilumab 300 mg as a loading dose administered on Day 1 (for a total of 600 mg) followed by one injection once every two weeks (q2w) until Week 16.
  • Drug: Oral Placebo

    Oral placebo (for PF-04965842) administered as two tablets to be taken orally once daily as follows:

    1. In the arm "Dupilumab Injection + Oral Placebo followed by Oral Placebo," the Oral Placebo is taken together with Dupilumab from Day 1 until Week 16, then by itself to Week 20;
    2. In the arms "Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842" and "Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842," subjects, take Oral Placebo from Day 1 until Week 16.
  • Drug: Injectable Placebo
    Two subcutaneous injections of Placebo (for Dupilumab) administered as a loading dose on Day 1 followed by one injection every other week (q2w) until Week 16.
  • Experimental: PF-04965842 100 mg + Placebo Inj followed by PF-04965842 100mg
    Once-daily oral PF-04965842 100 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 100 mg from Week 16 to Week 20
    Interventions:
    • Drug: PF-04965842 100 mg
    • Drug: Injectable Placebo
  • Experimental: PF-04965842 200 mg + Placebo Inj followed by PF-04965842 200mg
    Once-daily oral PF-04965842 200 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 200 mg from Week 16 to Week 20
    Interventions:
    • Drug: PF-04965842 200 mg
    • Drug: Injectable Placebo
  • Active Comparator: Dupilumab Injection + Oral Placebo followed by Oral Placebo
    Dupilumab injected subcutaneously once every 2 weeks + once-daily oral Placebo from Day 1 until Week 16 followed by once-daily oral Placebo from Week 16 to Week 20
    Interventions:
    • Drug: Dupilumab
    • Drug: Oral Placebo
  • Placebo Comparator: Oral Placebo + Placebo Inj followed by 100 mg PF-04965842
    Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 100 mg PF-04965842 from Week 16 to Week 20
    Interventions:
    • Drug: PF-04965842 100 mg
    • Drug: Oral Placebo
    • Drug: Injectable Placebo
  • Placebo Comparator: Oral Placebo + Placebo Inj followed by 200 mg PF-04965842
    Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 200 mg PF-04965842 from Week 16 to Week 20
    Interventions:
    • Drug: PF-04965842 200 mg
    • Drug: Oral Placebo
    • Drug: Injectable Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
700
Same as current
February 2, 2020
February 2, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects aged 18 years or older at the time of informed consent
  • Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4)
  • Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with medicated topical therapy for AD for at least 4 weeks, or who have required systemic therapies for control of their disease.
  • Must be willing and able to comply with standardized background topical therapy, as per protocol guidelines throughout the study
  • Female subjects who are of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:

    1. Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization;
    2. Female subjects of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.
  • Female subjects of non-childbearing potential must meet at least 1 of the following criteria:

    • Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    • Have medically confirmed ovarian failure; or
    • Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.

All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.

-If receiving concomitant medications for any reason other than AD, must be on a stable regimen prior to Day 1 and through the duration of the study

Exclusion Criteria:

  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
  • Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
  • Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
  • Other active nonAD inflammatory skin diseases or conditions affecting skin
  • Prior treatment with JAK inhibitors
  • Previous treatment with dupilumab
  • Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03720470
B7451029
COMPARE ( Other Identifier: Alias Study Number )
2018-002573-21 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now