Moderate-to-Severe Atopic Dermatitis with a History of Prior Systemic Treatment Failure MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: etrasimod
Product Code: PF-07915503
Pharmaceutical Form: Tablet
INN or Proposed INN: etrasimod
Current Sponsor code: PF-07915503
Other descriptive name: Etrasimod arginine
Concentration
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Chronic AD (also known as atopic eczema) that was diagnosed at least 1 year prior to Screening and meets Hanifin and Rajka criteria at screening). 2.Moderate to severe AD: a.IGA score =3 (on the 0 to 4 IGA scale, in which 3 = moderate and 4 = severe) at screening and baseline (Day 1) b.BSA =10% of AD involvement at screening and baseline (Day 1) c.Eczema Area and Severity Index (EASI) =16 at screening and baseline (Day 1) 3.A participant who has failed a prior systemic therapy for AD, ie, refractory, moderate-to-severe AD that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. (i.e., medical contraindications to systemic therapy prohibit use). a.Inadequate response to = 2 weeks of cyclosporine, azathioprine, methotrexate, mycophenolate, biologic, JAK inhibitors, or systemic corticosteroid (CS; defined as pulse of systemic CS or = 2 weeks of continuous oral CS), or when systemic therapy is inadvisable. - In Part 1, approximately 30% of participants are permitted with a failure of a prior systemic corticosteroid therapy without failing another systemic treatment for AD. For the remaining participants, failure of a prior systemic corticosteroid therapy alone is not sufficient to meet the criterion of prior systemic failure, i.e., the participant must fail another systemic treatment for AD. - In Part 2, failure of systemic corticosteroids may qualify a participant for the study. b.Refractory is an insufficient clinical response defined as the inability to achieve and maintain remission or a low disease activity state of minimal or mild lesions only, within 1 year of screening, despite treatment with systemic therapy for a period sufficient to demonstrate efficacy as determined by the Investigator. c.Acceptable documentation for these criteria includes chart notes that record medication prescription and treatment outcome, or Investigator documentation based on communication with the patient's treating physician. For study purposes, document failure of prior systemic drug(s) to adequately control AD in the CRF. 4.Willing to apply a topical emollient/moisturizer at least once daily for =1 week prior to baseline (Day 1) and willing to maintain consistent (ie, no change in type, frequency, or application) daily application over the course of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 388 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1.Presence of potential confounding factors: -Skin conditions (eg, psoriasis, seborrheic dermatitis) that may interfere with evaluation of AD or assessment of treatment response as deemed by the Investigator. -Current significant active infection or requiring a treatment for infection that may interfere with the assessment of AD. Study Arms and Duration: Part 1 (DB period and OLE period): -Etrasimod, 2 mg (tablet) QD for 16 weeks or Placebo (tablet) QD for 16 weeks; OLE period: Etrasimod, 2 mg (tablet) QD for 52 weeks. -Up to 76 weeks duration: including up to 4 weeks for screening, 16-week DB treatment period, 52-week OLE treatment period, and a safety follow-up at 2 and 4 weeks after treatment completion. Part 2 (OL period): -Etrasimod, 2 mg (tablet) QD for 52 weeks. -Up to 60 weeks duration: including up to 4 weeks for screening, 52-week OL treatment period, and a safety follow-up at 2 and 4 weeks after treatment completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -Part 1 DB: To evaluate the efficacy of etrasimod, 2 mg, QD versus placebo in adult participants with moderate-to-severe AD and a history of a prior systemic therapy failure. -Part 1 OLE and Part 2 (OL): To evaluate the long-term safety of oral etrasimod, 2 mg, QD in adult participants with moderate-to-severe AD and a history of a prior systemic therapy failure.;Secondary Objective: -Part 1 DB: To evaluate the efficacy of etrasimod, 2 mg, QD based on additional measures in adult participants with moderate-to-severe AD and a history of a prior systemic therapy failure. -Part 1 OLE and Part 2: To evaluate the long-term efficacy of oral etrasimod, 2 mg, QD in adult participants with moderate-to-severe AD and a history of a prior systemic therapy failure.;Primary end point(s): - Proportion of participants achieving IGA of clear (0) or almost clear (1) (on a 5-point scale) and a reduction of = 2 points from baseline at Week 16. - Incidence and severity of treatment-emergent AEs, AEs leading to study treatment discontinuation, SAEs, and AESIs. -Incidence of clinically significant changes in clinical laboratory values, ECG measurements and vital signs. ;Timepoint(s) of evaluation of this end point: - At Week 16 - Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Proportion of participants achieving a EASI-75 at Week 16. -Percent change from baseline in EASI at Week 16. ;Timepoint(s) of evaluation of this end point: 16 weeks | — |
Countries
Australia, Bulgaria, Canada, Czechia, Czech Republic, France, Germany, Italy, Mexico, Poland, Spain, United States
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc.
Outcome results
None listed