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

Primary Purpose

Psoriasis, Skin Diseases, Skin Diseases, Papulosquamous

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Placebo

Baricitinib

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Moderate, Severe, Plaque, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)
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
You must not have a serious and/or unstable illness that, in the opinion of the investigator, poses an unacceptable risk for the your participation in the study
You must not have or have had a history of lymphoproliferative disease; or signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or active primary or recurrent malignant disease; or been in remission from clinically significant malignancy for less than 5 years
You must not have a history of chronic alcohol abuse or intravenous (IV) drug abuse within the last 2 years
You must not have donated blood of more than 500 mL within 4 weeks
You must not have received a topical Ps treatment within 2 weeks prior to entry into the study
- Exceptions:
- class 6 (mild, such as desonide) or class 7 (least potent, such as hydrocortisone) topical steroids used on the face, axilla, palms, soles, and/or genitalia
- non-medicated shampoos (for example, that do not contain corticosteroids, coal tar, or vitamin D3 analogues)
- emollients that do not contain alpha or beta hydroxyl acids

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Baricitinib 2 mg

Baricitinib 4 mg

Baricitinib 8 mg

Baricitinib 10 mg

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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])

The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.

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])

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])

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, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares Means (LS Means) were calculated using an analysis of covariance (ANCOVA) model on the last observation carried forward (LOCF) with treatment group as a fixed effect and baseline PASI score as a continuous covariate.

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])

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])

Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 12

The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.

Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24

Change From Baseline Part D in Dermatology Life Quality Index (DLQI) Total Score to Week 92

Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score at Week 12

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.

Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24

Change From Baseline Part D in Itch Numeric Rating Scale (Itch NRS) Score to Week 92

Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score at Week 12

The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.

Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24

The QIDS-SR16 is a 16-item, self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (APA 1994). A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 to 3. The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The domains assessed by the instrument include: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation, (5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation.

Change From Baseline Part D in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 92

Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores

The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the "worst health you can imagine" and 100 mm indicated the "best health you can imagine". This information is used as a quantitative measure of health outcome. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.

Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores

Change From Baseline Part D in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores

Percentage of Participants Experiencing Rebound Upon Discontinuation of Study Drug in Part C

Rebound was defined as worsening of psoriasis compared to baseline at Week 0 (for example, PASI score >125% of baseline value) or new pustular, erythrodermic, or more inflammatory psoriasis occurring within 3 months of stopping study drug.

Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib

PK: Area Under the Concentration-Time Curve Versus Time During One Dosing Interval at Steady State (AUC τ,ss)

Full Information

NCT ID

NCT01490632

First Posted

December 9, 2011

Last Updated

September 10, 2019

Sponsor

Eli Lilly and Company

Collaborators

Incyte Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01490632

Brief Title

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

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Phase 2b Study of Baricitinib in Patients With Moderate-to-Severe Plaque Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

Collaborators

Incyte Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis, Skin Diseases, Skin Diseases, Papulosquamous

Keywords

Moderate, Severe, Plaque, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

271 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Baricitinib 2 mg

Arm Type

Experimental

Arm Description

Arm Title

Baricitinib 4 mg

Arm Type

Experimental

Arm Description

Arm Title

Baricitinib 8 mg

Arm Type

Experimental

Arm Description

Arm Title

Baricitinib 10 mg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Baricitinib

Other Intervention Name(s)

LY3009104, INCB028050

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Description

Time Frame

Week 12

Title

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])

Description

Time Frame

Week 24

Title

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])

Description

Time Frame

Week 92

Title

Description

Time Frame

Baseline Part A, Week 12

Title

Description

Time Frame

Baseline Part A, Week 24

Title

Description

Time Frame

Baseline Part D, Week 92

Title

Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 12

Description

Time Frame

Baseline Part A, Week 12

Title

Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24

Description

Time Frame

Baseline Part A, Week 24

Title

Change From Baseline Part D in Dermatology Life Quality Index (DLQI) Total Score to Week 92

Description

Time Frame

Baseline Part D, Week 92

Title

Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score at Week 12

Description

Time Frame

Baseline Part A, Week 12

Title

Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24

Description

Time Frame

Baseline Part A, Week 24

Title

Change From Baseline Part D in Itch Numeric Rating Scale (Itch NRS) Score to Week 92

Description

Time Frame

Baseline Part D, Week 92

Title

Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score at Week 12

Description

Time Frame

Baseline Part A, Week 12

Title

Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24

Description

Time Frame

Baseline Part A, Week 24

Title

Change From Baseline Part D in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 92

Description

Time Frame

Baseline Part D, Week 92

Title

Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores

Description

Time Frame

Baseline Part A, Week 12

Title

Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores

Description

Time Frame

Baseline Part A, Week 24

Title

Change From Baseline Part D in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores

Description

Time Frame

Baseline Part D, Week 92

Title

Percentage of Participants Experiencing Rebound Upon Discontinuation of Study Drug in Part C

Description

Time Frame

Week 40

Title

Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib

Time Frame

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

Title

PK: Area Under the Concentration-Time Curve Versus Time During One Dosing Interval at Steady State (AUC τ,ss)

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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) 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 You must not have a serious and/or unstable illness that, in the opinion of the investigator, poses an unacceptable risk for the your participation in the study You must not have or have had a history of lymphoproliferative disease; or signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or active primary or recurrent malignant disease; or been in remission from clinically significant malignancy for less than 5 years You must not have a history of chronic alcohol abuse or intravenous (IV) drug abuse within the last 2 years You must not have donated blood of more than 500 mL within 4 weeks You must not have received a topical Ps treatment within 2 weeks prior to entry into the study Exceptions: class 6 (mild, such as desonide) or class 7 (least potent, such as hydrocortisone) topical steroids used on the face, axilla, palms, soles, and/or genitalia non-medicated shampoos (for example, that do not contain corticosteroids, coal tar, or vitamin D3 analogues) emollients that do not contain alpha or beta hydroxyl acids

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Facility Name

City

Miramar

State/Province

Florida

ZIP/Postal Code

33027

Country

United States

Facility Name

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

City

Alpharetta

State/Province

Georgia

ZIP/Postal Code

30022

Country

United States

Facility Name

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60005

Country

United States

Facility Name

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

City

East Windsor

State/Province

New Jersey

ZIP/Postal Code

08520

Country

United States

Facility Name

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87104

Country

United States

Facility Name

City

Rochester

State/Province

New York

ZIP/Postal Code

14623

Country

United States

Facility Name

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

City

Exton

State/Province

Pennsylvania

ZIP/Postal Code

19341

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19103

Country

United States

Facility Name

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 4X3

Country

Canada

Facility Name

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3R 6A7

Country

Canada

Facility Name

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9J 1Z2

Country

Canada

Facility Name

City

Richmond Hill

State/Province

Ontario

ZIP/Postal Code

L4B 1A5

Country

Canada

Facility Name

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H1Z1

Country

Canada

Facility Name

City

Quebec

ZIP/Postal Code

G1V4X7

Country

Canada

Facility Name

City

Chiba

ZIP/Postal Code

292-8535

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

814-0180

Country

Japan

Facility Name

City

Ishikawa

ZIP/Postal Code

923-8560

Country

Japan

Facility Name

City

Kanagawa

ZIP/Postal Code

2308765

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

City

Saitama

ZIP/Postal Code

350-0495

Country

Japan

Facility Name

City

Tochigi

ZIP/Postal Code

329- 0498

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

162-8543

Country

Japan

Facility Name

City

Toyama

ZIP/Postal Code

9330871

Country

Japan

Facility Name

City

Carolina

ZIP/Postal Code

00985

Country

Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Learn more about this trial

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

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