A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Phase 2b Study of Baricitinib in Patients With Moderate-to-Severe Plaque Psoriasis
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Psoriasis
- Sponsor
- Eli Lilly and Company
- Enrollment
- 271
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This is a dose-ranging study designed to investigate the efficacy and safety of Baricitinib in the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments.
Investigators
Eligibility Criteria
Inclusion Criteria
- •You must have active chronic plaque psoriasis for at least 6 months prior to entry into the study
- •You are a candidate for systemic therapy and/or phototherapy
- •You must have active plaque psoriasis covering at least 12% body surface area
- •You must have Psoriasis Area and Severity Index (PASI) score of at least 12
- •You must have Static Physician's Global Assessment (sPGA) score of at least 3
Exclusion Criteria
- •You must not have received a biologic agent/monoclonal antibody within 8 weeks prior to entry into the study
- •You must not have prior treatment with an oral Janus kinase (JAK) inhibitor
- •You must not have received a systemic psoriasis (Ps) therapy within 4 weeks prior to entry into the study
- •You must not have received a phototherapy within 4 weeks prior to entry into the study
- •You must not have received a topical Ps therapy with psoralens within 4 weeks prior to entry into the study
- •You must not be pregnant or nursing
- •If female of childbearing potential or a male, and do not agree to use 2 forms of highly effective methods of birth control for at least 28 days following the last dose of investigational product
- •You must not have had symptomatic herpes zoster or herpes simplex infection within 12 weeks or have a history of disseminated/complicated herpes zoster
- •You must not have evidence of active infection, such as fever ≥38.0ºC (100.4ºF)
- •You must not have a history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
Arms & Interventions
Placebo
Part A: Placebo administered orally (PO) once daily (QD) for 12 weeks. Part B: Placebo participants stayed on placebo or re-randomized to baricitinib 8 milligram (mg) or 10 mg PO QD for 12 weeks. Part C: Baricitinib participants re-randomized to 4 mg or placebo PO QD for 16 weeks. Part D: Retreated with Part B efficacious dose.
Intervention: Placebo
Baricitinib 2 mg
Part A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or re-randomized to increased dose PO QD for 12 weeks. Part C: Participants re-randomized to half dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.
Intervention: Baricitinib
Baricitinib 4 mg
Part A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or re-randomized to increased dose PO QD for 12 weeks. Part C: Participants re-randomized to half dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.
Intervention: Baricitinib
Baricitinib 8 mg
Part A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or re-randomized to increased dose PO QD for 12 weeks. Part C: Participants re-randomized to half dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.
Intervention: Baricitinib
Baricitinib 10 mg
Part A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or discontinued from the study for 12 weeks. Part C: Participants re-randomized to 4mg dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.
Intervention: Baricitinib
Outcomes
Primary Outcomes
Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])
Time Frame: Week 12
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema (redness), and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.
Secondary Outcomes
- Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])(Week 12)
- Percentage of Participants Achieving an sPGA of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])(Week 92)
- Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 12 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])(Baseline Part A, Week 12)
- Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 24 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis: Measure: Psoriasis Area and Severity Index [PASI])(Baseline Part A, Week 24)
- Change From Baseline in Part D in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 92 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])(Baseline Part D, Week 92)
- Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 12(Baseline Part A, Week 12)
- Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24(Baseline Part A, Week 24)
- Change From Baseline Part D in Dermatology Life Quality Index (DLQI) Total Score to Week 92(Baseline Part D, Week 92)
- Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score at Week 12(Baseline Part A, Week 12)
- Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24(Baseline Part A, Week 24)
- Change From Baseline Part D in Itch Numeric Rating Scale (Itch NRS) Score to Week 92(Baseline Part D, Week 92)
- Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score at Week 12(Baseline Part A, Week 12)
- Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24(Baseline Part A, Week 24)
- Change From Baseline Part D in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 92(Baseline Part D, Week 92)
- Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores(Baseline Part A, Week 24)
- Change From Baseline Part D in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores(Baseline Part D, Week 92)
- Percentage of Participants Experiencing Rebound Upon Discontinuation of Study Drug in Part C(Week 40)
- Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib(Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse)
- PK: Area Under the Concentration-Time Curve Versus Time During One Dosing Interval at Steady State (AUC τ,ss)(Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse)