A Phase 2b Study of Baricitinib in Participants With Moderate to Severe Psoriasis

Conditions

• Psoriasis
• Skin Diseases
• Skin Diseases, Papulosquamous

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Administered orally
• Baricitinib — DRUG
  Administered orally

Study Details

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.

Key Dates

Start date

Dec 31, 2011

Status verified

Sep 2019

Primary completion

Dec 31, 2012

Completion

Aug 31, 2014

Study Design

Enrollment

271 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.

Primary Outcome Measure

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 ]

Locations (18)

Find similar trials in Bakersfield, CA

Related Studies

• Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
  Recruiting · University of California, San Diego · La Jolla, California
• LTS of Siliq vs. Other Therapies Treating of Adults With Moderate-to-Severe Psoriasis
  Enrolling By Invitation · Bausch Health Americas, Inc. · Bridgewater, New Jersey
• An Open-Label, Pilot Study to Evaluate the Efficacy of Narrowband Ultraviolet-B Phototherapy Three Times Weekly for Twelve Weeks in Moderate-to-Severe Psoriasis Patients
  Recruiting · Psoriasis Treatment Center of Central New Jersey · East Windsor, New Jersey
• Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
  PHASE1 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama