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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

271

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Dec 2011

Geographic Reach

4 countries

35 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

Study Start

First participant enrolled

December 1, 2011

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2011

Completed

4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed

1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed

3 years until next milestone

Results Posted

Study results publicly available

July 18, 2017

Completed

Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

December 9, 2011

Results QC Date

March 10, 2017

Last Update Submit

September 10, 2019

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous

Keywords

ModerateSeverePlaqueChronic

Outcome Measures

Primary Outcomes (1)

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])
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.
Week 12

Secondary Outcomes (21)

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 24
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
+16 more secondary outcomes

Study Arms (5)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Baricitinib 2 mg

EXPERIMENTAL

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.

Drug: Baricitinib

Baricitinib 4 mg

EXPERIMENTAL

Drug: Baricitinib

Baricitinib 8 mg

EXPERIMENTAL

Drug: Baricitinib

Baricitinib 10 mg

EXPERIMENTAL

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.

Drug: Baricitinib

Interventions

PlaceboDRUG

Administered orally

Placebo

BaricitinibDRUG

Administered orally

Also known as: LY3009104, INCB028050

Baricitinib 10 mgBaricitinib 2 mgBaricitinib 4 mgBaricitinib 8 mg

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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)
You must not be immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study
You must not have known history hypogammaglobulinemia
You must not have had a serious systemic or local infection within 12 weeks prior to entry into the study
You must not have been exposed to a live vaccine within 12 weeks prior to entry into the study, or expected to need/receive a live vaccine (including herpes zoster vaccination) during the course of the study
You must not have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB
+9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead
Incyte Corporationcollaborator

Study Sites (35)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bakersfield, California, 93309, United States

Location

Santa Monica, California, 90404, United States

Location

Miami, Florida, 33175, United States

Location

Miramar, Florida, 33027, United States

Location

Ocala, Florida, 34471, United States

Location

Alpharetta, Georgia, 30022, United States

Location

Arlington Heights, Illinois, 60005, United States

Location

Louisville, Kentucky, 40202, United States

Location

East Windsor, New Jersey, 08520, United States

Location

Albuquerque, New Mexico, 87104, United States

Location

Rochester, New York, 14623, United States

Location

Winston-Salem, North Carolina, 27103, United States

Location

Exton, Pennsylvania, 19341, United States

Location

Philadelphia, Pennsylvania, 19103, United States

Location

Austin, Texas, 78705, United States

Location

Dallas, Texas, 75246, United States

Location

Salt Lake City, Utah, 84132, United States

Location

Seattle, Washington, 98101, United States

Location

Kelowna, British Columbia, V1Y 4X3, Canada

Location

Surrey, British Columbia, V3R 6A7, Canada

Location

Peterborough, Ontario, K9J 1Z2, Canada

Location

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Waterloo, Ontario, N2J 1C4, Canada

Location

Sherbrooke, Quebec, J1H1Z1, Canada

Location

Québec, G1V4X7, Canada

Location

Chiba, 292-8535, Japan

Location

Fukuoka, 814-0180, Japan

Location

Ishikawa, 923-8560, Japan

Location

Kanagawa, 2308765, Japan

Location

Osaka, 545-8586, Japan

Location

Saitama, 350-0495, Japan

Location

Tochigi, 329- 0498, Japan

Location

Tokyo, 162-8543, Japan

Location

Toyama, 9330871, Japan

Location

Carolina, 00985, Puerto Rico

Location

MeSH Terms

Conditions

PsoriasisSkin DiseasesSkin Diseases, PapulosquamousLymphoma, FollicularPlaque, AmyloidBronchiolitis Obliterans Syndrome

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host Disease

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 9, 2011

First Posted

December 13, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2012

Study Completion

August 1, 2014

Last Updated

September 27, 2019

Results First Posted

July 18, 2017

Record last verified: 2019-09

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, CSR
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US(18)PR(1)JP(9)CA(7)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (21)

Study Arms (5)

Placebo

Baricitinib 2 mg

Baricitinib 4 mg

Baricitinib 8 mg

Baricitinib 10 mg

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (35)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations