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

Conditions

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Genetic Diseases, Inborn
• Hypersensitivity
• Hypersensitivity, Immediate
• Immune System Diseases
• Skin Diseases
• Skin Diseases, Eczematous
• Skin Diseases, Genetic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PF-04965842 100 mg — DRUG
  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.
• PF-04965842 200 mg — DRUG
  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.
• Dupilumab — DRUG
  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.
• Oral Placebo — DRUG
  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.
• Injectable Placebo — DRUG
  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.

Study Details

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.

Key Dates

Start date

Oct 29, 2018

Status verified

Dec 2020

Primary completion

Dec 27, 2019

Completion

Mar 6, 2020

Study Design

Enrollment

838 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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
• 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
• 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
• 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
• 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

Primary Outcome Measure

Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Week 12 [ Time Frame: Baseline (the last measurement prior to first dosing on Day 1), Week 12 ]

Locations (60)

Find similar trials in Birmingham, AL

Related Studies

• Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
  Recruiting · University of Pittsburgh · Pittsburgh, Pennsylvania
• Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• A Long-term Follow-up Study in Participants Who Received CTX001
  PHASE3 · Enrolling By Invitation · Vertex Pharmaceuticals Incorporated · Palo Alto, California