Psoriasis, Skin Diseases, Skin Diseases, Papulosquamous
Conditions
Keywords
Moderate, Severe, Plaque, Chronic
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.
Interventions
DRUGPlacebo
Administered orally
DRUGBaricitinib
Administered orally
Sponsors
Incyte Corporation
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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]) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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]) | Baseline Part A, Week 24 | 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. |
| 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 | 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. |
| Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 12 | Baseline Part A, 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 | Baseline Part A, Week 24 | 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. |
| Change From Baseline Part D in Dermatology Life Quality Index (DLQI) Total Score to Week 92 | Baseline Part D, Week 92 | 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. |
| Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score at Week 12 | Baseline Part A, 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 | Baseline Part A, Week 24 | 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. |
| 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 | 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. |
| 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 | 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 | Baseline Part A, 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 | Baseline Part D, Week 92 | 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 A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | Baseline Part A, Week 12 | 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 D in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | Baseline Part D, Week 92 | 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. |
| Percentage of Participants Experiencing Rebound Upon Discontinuation of Study Drug in Part C | Week 40 | 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 | 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 | — |
| Change From Baseline Part D in Itch Numeric Rating Scale (Itch NRS) Score to Week 92 | Baseline Part D, Week 92 | 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. |
Countries
Canada, Japan, Puerto Rico, United States
Participant flow
Recruitment details
Participant Psoriasis Area and Severity Index (PASI) score at the conclusion of Part A stratified participants as either Responder (PASI ≥75), Partial Responder (PASI 50 - PASI 74), or Non-Responder (PASI \<50).
Pre-assignment details
Part A: Initial Treatment Period (Weeks 0 up to 12) Part B: Extension or Step-Up Period (Week 12 up to Week 24) Part C: Washout or Step-Down Period (Week 24 up to Week 40) Part D: (Re-Treatment Period up to 52 Weeks)
Participants by arm
| Arm | Count |
|---|---|
| Part A: Placebo Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks. | 34 |
| Part A: Baricitinib 2 mg Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks. | 32 |
| Part A: Baricitinib 4 mg Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks. | 72 |
| Part A: Baricitinib 8 mg Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks. | 64 |
| Part A: Baricitinib 10 mg Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study. | 69 |
| Total | 271 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A: Initial Treatment Period | Adverse Event | 0 | 0 | 2 | 4 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A: Initial Treatment Period | Discontinued at Week 12 per protocol | 0 | 0 | 0 | 0 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A: Initial Treatment Period | Lack of Efficacy | 3 | 1 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A: Initial Treatment Period | Lost to Follow-up | 0 | 0 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A: Initial Treatment Period | Physician Decision | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A: Initial Treatment Period | Sponsor Decision | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A: Initial Treatment Period | Withdrawal by Subject | 2 | 2 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B: Extension or Step-Up Period | Adverse Event | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 0 | 0 | 2 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B: Extension or Step-Up Period | Completed Part B and Not Moving to PartC | 0 | 0 | 0 | 0 | 0 | 1 | 6 | 6 | 8 | 19 | 16 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B: Extension or Step-Up Period | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B: Extension or Step-Up Period | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B: Extension or Step-Up Period | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B: Extension or Step-Up Period | Sponsor Decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B: Extension or Step-Up Period | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part C: Washout or Step-Down Period | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 0 | 0 | 0 | 0 |
| Part C: Washout or Step-Down Period | Did Not Qualify for Part D Per Protocol | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 9 | 14 | 34 | 0 | 0 | 0 | 0 |
| Part C: Washout or Step-Down Period | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part C: Washout or Step-Down Period | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 |
| Part D: Re-Treatment Period | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 3 |
| Part D: Re-Treatment Period | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Part D: Re-Treatment Period | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 2 |
| Part D: Re-Treatment Period | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Part D: Re-Treatment Period | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Part D: Re-Treatment Period | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Part D: Re-Treatment Period | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Part A: Placebo | Part A: Baricitinib 2 mg | Part A: Baricitinib 4 mg | Part A: Baricitinib 8 mg | Part A: Baricitinib 10 mg | Total |
|---|---|---|---|---|---|---|
| Age, Customized | 46.70 Years STANDARD_DEVIATION 15.144 | 47.81 Years STANDARD_DEVIATION 15.165 | 47.21 Years STANDARD_DEVIATION 11.65 | 47.37 Years STANDARD_DEVIATION 15.829 | 47.43 Years STANDARD_DEVIATION 10.425 | 47.31 Years STANDARD_DEVIATION 13.268 |
| Baseline Psoriasis Area and Severity Index (PASI) Score | 19.06 Units on a Scale STANDARD_DEVIATION 6.805 | 21.36 Units on a Scale STANDARD_DEVIATION 11.056 | 20.58 Units on a Scale STANDARD_DEVIATION 9.438 | 20.24 Units on a Scale STANDARD_DEVIATION 7.827 | 19.01 Units on a Scale STANDARD_DEVIATION 6.177 | 20.00 Units on a Scale STANDARD_DEVIATION 8.228 |
| Duration of Psoriasis (Ps) | 16.42 Years STANDARD_DEVIATION 14.297 | 15.00 Years STANDARD_DEVIATION 9.951 | 19.90 Years STANDARD_DEVIATION 12.766 | 16.56 Years STANDARD_DEVIATION 11.948 | 16.60 Years STANDARD_DEVIATION 10.653 | 17.26 Years STANDARD_DEVIATION 11.995 |
| Percent Body Surface Area (BSA) Affected by Psoriasis | 23.18 Percent of BSA STANDARD_DEVIATION 11.89 | 30.78 Percent of BSA STANDARD_DEVIATION 20.523 | 28.61 Percent of BSA STANDARD_DEVIATION 18.797 | 28.23 Percent of BSA STANDARD_DEVIATION 15.726 | 24.45 Percent of BSA STANDARD_DEVIATION 12.079 | 27.04 Percent of BSA STANDARD_DEVIATION 16.101 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 7 Participants | 6 Participants | 12 Participants | 9 Participants | 11 Participants | 45 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 4 Participants | 6 Participants | 11 Participants | 12 Participants | 10 Participants | 43 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 30 Participants | 26 Participants | 61 Participants | 52 Participants | 59 Participants | 228 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 26 Participants | 26 Participants | 58 Participants | 52 Participants | 53 Participants | 215 Participants |
| Region of Enrollment Japan | 4 Participants | 4 Participants | 9 Participants | 8 Participants | 8 Participants | 33 Participants |
| Region of Enrollment North America | 30 Participants | 28 Participants | 63 Participants | 56 Participants | 61 Participants | 238 Participants |
| Sex/Gender, Customized Female | 11 Participants | 9 Participants | 18 Participants | 18 Participants | 18 Participants | 74 Participants |
| Sex/Gender, Customized Male | 23 Participants | 23 Participants | 54 Participants | 46 Participants | 51 Participants | 197 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 34 | 9 / 32 | 12 / 72 | 21 / 64 | 23 / 69 | 4 / 8 | 13 / 45 | 41 / 176 | 11 / 70 | 16 / 71 | 37 / 72 | 0 / 8 | 8 / 185 |
| serious Total, serious adverse events | 1 / 34 | 1 / 32 | 1 / 72 | 1 / 64 | 1 / 69 | 0 / 8 | 0 / 45 | 2 / 176 | 1 / 70 | 1 / 71 | 1 / 72 | 0 / 8 | 0 / 185 |
Outcome results
Primary
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.
Time frame: Week 12
Population: North American (NA) modified intent-to-treat (mITT) population: All NA randomized participants who received at least one dose of study drug. Non-responders and participants who discontinued study drug any time prior to time point of interest, or discontinued from study, were defined as non-responders for the non-responder imputation (NRI) analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | 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]) | 16.7 Percent of Participants |
| Part A: Baricitinib 2 mg | 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]) | 28.6 Percent of Participants |
| Part A: Baricitinib 4 mg | 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]) | 28.6 Percent of Participants |
| Part A: Baricitinib 8 mg | 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]) | 42.9 Percent of Participants |
| Part A: Baricitinib 10 mg | 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]) | 54.1 Percent of Participants |
Secondary
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.
Time frame: Baseline Part A, Week 12
Population: All randomized participants who received at least one dose of study drug. Missing values were imputed with the last observation carried forward (LOCF) method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | 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]) | 5.14 Units on a Scale | Standard Error 1.37 |
| Part A: Baricitinib 2 mg | 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]) | 9.40 Units on a Scale | Standard Error 1.413 |
| Part A: Baricitinib 4 mg | 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]) | 9.46 Units on a Scale | Standard Error 0.941 |
| Part A: Baricitinib 8 mg | 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]) | 11.52 Units on a Scale | Standard Error 0.997 |
| Part A: Baricitinib 10 mg | 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]) | 13.93 Units on a Scale | Standard Error 0.962 |
Secondary
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])
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.
Time frame: Baseline Part A, Week 24
Population: All randomized participants who received at least one dose of study drug and at least 1 post-baseline observation in Part A at or prior to week 24. Missing values were imputed with the last observation carried forward (LOCF) method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | 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]) | 15.62 Units on a Scale | Standard Deviation 5.48 |
| Part A: Baricitinib 2 mg | 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]) | 16.69 Units on a Scale | Standard Deviation 7.399 |
| Part A: Baricitinib 4 mg | 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]) | 12.94 Units on a Scale | Standard Deviation 6.711 |
| Part A: Baricitinib 8 mg | 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]) | 12.23 Units on a Scale | Standard Deviation 7.51 |
| Part A: Baricitinib 10 mg | 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]) | 14.55 Units on a Scale | Standard Deviation 10.493 |
| Part B: Partial- and Non-responder - High Dose to High Dose | 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]) | 13.67 Units on a Scale | Standard Deviation 9.966 |
| Part B: Placebo Extension | 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]) | 13.43 Units on a Scale | Standard Deviation 5.599 |
Secondary
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])
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.
Time frame: Baseline Part D, Week 92
Population: All randomized participants who received ≥1 dose of study drug and has 1 post-baseline observation at or prior to week 92. Missing values were imputed with the last observation carried forward (LOCF) method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | 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]) | 6.33 Units on a Scale | Standard Deviation 2.836 |
| Part A: Baricitinib 2 mg | 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]) | 3.25 Units on a Scale | Standard Deviation 4.447 |
| Part A: Baricitinib 4 mg | 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]) | 5.84 Units on a Scale | Standard Deviation 5.544 |
| Part A: Baricitinib 8 mg | 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]) | 6.98 Units on a Scale | Standard Deviation 6.456 |
Secondary
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.
Time frame: Baseline Part A, Week 12
Population: All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 12 | -1.7 Units on a Scale | Standard Error 0.98 |
| Part A: Baricitinib 2 mg | Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 12 | -3.4 Units on a Scale | Standard Error 1 |
| Part A: Baricitinib 4 mg | Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 12 | -4.6 Units on a Scale | Standard Error 0.67 |
| Part A: Baricitinib 8 mg | Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 12 | -4.0 Units on a Scale | Standard Error 0.71 |
| Part A: Baricitinib 10 mg | Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 12 | -5.1 Units on a Scale | Standard Error 0.69 |
Secondary
Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24
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.
Time frame: Baseline Part A, Week 24
Population: All randomized participants who received ≥1 dose of study drug in Part B and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | -6.9 Units on a Scale | Standard Deviation 7.53 |
| Part A: Baricitinib 2 mg | Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | -7.0 Units on a Scale | Standard Deviation 8.18 |
| Part A: Baricitinib 4 mg | Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | -3.8 Units on a Scale | Standard Deviation 6.27 |
| Part A: Baricitinib 8 mg | Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | -1.5 Units on a Scale | Standard Deviation 5.92 |
| Part A: Baricitinib 10 mg | Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | -7.8 Units on a Scale | Standard Deviation 6.89 |
| Part B: Partial- and Non-responder - High Dose to High Dose | Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | -4.5 Units on a Scale | Standard Deviation 8.99 |
| Part B: Placebo Extension | Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24 | -3.5 Units on a Scale | Standard Deviation 11.76 |
Secondary
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.
Time frame: Baseline Part A, Week 12
Population: All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. As observed values were used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | 2.9 Millimeter (mm) | Standard Error 2.55 |
| Part A: Baricitinib 2 mg | Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | 5.7 Millimeter (mm) | Standard Error 2.46 |
| Part A: Baricitinib 4 mg | Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | 6.4 Millimeter (mm) | Standard Error 1.62 |
| Part A: Baricitinib 8 mg | Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | 9.5 Millimeter (mm) | Standard Error 1.71 |
| Part A: Baricitinib 10 mg | Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | 7.8 Millimeter (mm) | Standard Error 1.69 |
Secondary
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.
Time frame: Baseline Part A, Week 24
Population: All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. As observed values were used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | 8.1 mm | Standard Deviation 11.41 |
| Part A: Baricitinib 2 mg | Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | 13.2 mm | Standard Deviation 22.06 |
| Part A: Baricitinib 4 mg | Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | 9.6 mm | Standard Deviation 10.78 |
| Part A: Baricitinib 8 mg | Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | 9.4 mm | Standard Deviation 20.95 |
| Part A: Baricitinib 10 mg | Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | 7.5 mm | Standard Deviation 14.47 |
| Part B: Partial- and Non-responder - High Dose to High Dose | Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | 10.5 mm | Standard Deviation 19.94 |
| Part B: Placebo Extension | Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | 7.8 mm | Standard Deviation 11.92 |
Secondary
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.
Time frame: Baseline Part A, Week 12
Population: All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score at Week 12 | -1.1 Units on a Scale | Standard Error 0.48 |
| Part A: Baricitinib 2 mg | Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score at Week 12 | -2.8 Units on a Scale | Standard Error 0.49 |
| Part A: Baricitinib 4 mg | Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score at Week 12 | -3.3 Units on a Scale | Standard Error 0.33 |
| Part A: Baricitinib 8 mg | Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score at Week 12 | -3.8 Units on a Scale | Standard Error 0.35 |
| Part A: Baricitinib 10 mg | Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score at Week 12 | -4.7 Units on a Scale | Standard Error 0.34 |
Secondary
Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24
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.
Time frame: Baseline Part A, Week 24
Population: All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24 | -4.7 Units on a Scale | Standard Deviation 3.52 |
| Part A: Baricitinib 2 mg | Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24 | -5.6 Units on a Scale | Standard Deviation 2.96 |
| Part A: Baricitinib 4 mg | Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24 | -5.4 Units on a Scale | Standard Deviation 3.83 |
| Part A: Baricitinib 8 mg | Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24 | -3.4 Units on a Scale | Standard Deviation 3.69 |
| Part A: Baricitinib 10 mg | Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24 | -4.1 Units on a Scale | Standard Deviation 3.33 |
| Part B: Partial- and Non-responder - High Dose to High Dose | Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24 | -3.5 Units on a Scale | Standard Deviation 3.03 |
| Part B: Placebo Extension | Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24 | -2.5 Units on a Scale | Standard Deviation 4.11 |
Secondary
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.
Time frame: Baseline Part A, Week 12
Population: All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. Missing values were imputed with the last observation carried forward (LOCF) method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score at Week 12 | -0.9 Units on a Scale | Standard Error 0.57 |
| Part A: Baricitinib 2 mg | Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score at Week 12 | -1.0 Units on a Scale | Standard Error 0.58 |
| Part A: Baricitinib 4 mg | Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score at Week 12 | -1.0 Units on a Scale | Standard Error 0.39 |
| Part A: Baricitinib 8 mg | Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score at Week 12 | -0.7 Units on a Scale | Standard Error 0.4 |
| Part A: Baricitinib 10 mg | Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score at Week 12 | -0.9 Units on a Scale | Standard Error 0.4 |
Secondary
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.
Time frame: Baseline Part A, Week 24
Population: All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. As observed values were used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24 | -1.6 Units on a Scale | Standard Deviation 2.48 |
| Part A: Baricitinib 2 mg | Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24 | -2.6 Units on a Scale | Standard Deviation 3.8 |
| Part A: Baricitinib 4 mg | Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24 | -1.4 Units on a Scale | Standard Deviation 3.15 |
| Part A: Baricitinib 8 mg | Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24 | -1.2 Units on a Scale | Standard Deviation 2.67 |
| Part A: Baricitinib 10 mg | Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24 | -1.6 Units on a Scale | Standard Deviation 2.99 |
| Part B: Partial- and Non-responder - High Dose to High Dose | Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24 | -2.2 Units on a Scale | Standard Deviation 4.64 |
| Part B: Placebo Extension | Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24 | -3.0 Units on a Scale | Standard Deviation 6.16 |
Secondary
Change From Baseline Part D in Dermatology Life Quality Index (DLQI) Total Score to Week 92
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.
Time frame: Baseline Part D, Week 92
Population: All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Change From Baseline Part D in Dermatology Life Quality Index (DLQI) Total Score to Week 92 | -3.3 Units on a Scale | Standard Deviation 4.93 |
| Part A: Baricitinib 2 mg | Change From Baseline Part D in Dermatology Life Quality Index (DLQI) Total Score to Week 92 | -0.5 Units on a Scale | Standard Deviation 3.62 |
| Part A: Baricitinib 4 mg | Change From Baseline Part D in Dermatology Life Quality Index (DLQI) Total Score to Week 92 | -2.1 Units on a Scale | Standard Deviation 7.4 |
| Part A: Baricitinib 8 mg | Change From Baseline Part D in Dermatology Life Quality Index (DLQI) Total Score to Week 92 | -5.0 Units on a Scale | Standard Deviation 6.31 |
Secondary
Change From Baseline Part D 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.
Time frame: Baseline Part D, Week 92
Population: All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. Missing values were imputed with the last observation carried forward (LOCF) method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Change From Baseline Part D in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | 8.67 mm | Standard Deviation 10.263 |
| Part A: Baricitinib 2 mg | Change From Baseline Part D in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | 4.00 mm | Standard Deviation 26.92 |
| Part A: Baricitinib 4 mg | Change From Baseline Part D in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | 4.78 mm | Standard Deviation 13.571 |
| Part A: Baricitinib 8 mg | Change From Baseline Part D in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores | 4.19 mm | Standard Deviation 19.727 |
Secondary
Change From Baseline Part D in Itch Numeric Rating Scale (Itch NRS) Score to Week 92
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.
Time frame: Baseline Part D, Week 92
Population: All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Change From Baseline Part D in Itch Numeric Rating Scale (Itch NRS) Score to Week 92 | -2.3 Units on a Scale | Standard Deviation 0.58 |
| Part A: Baricitinib 2 mg | Change From Baseline Part D in Itch Numeric Rating Scale (Itch NRS) Score to Week 92 | -2.5 Units on a Scale | Standard Deviation 3.23 |
| Part A: Baricitinib 4 mg | Change From Baseline Part D in Itch Numeric Rating Scale (Itch NRS) Score to Week 92 | -2.7 Units on a Scale | Standard Deviation 2.91 |
| Part A: Baricitinib 8 mg | Change From Baseline Part D in Itch Numeric Rating Scale (Itch NRS) Score to Week 92 | -3.1 Units on a Scale | Standard Deviation 3.38 |
Secondary
Change From Baseline Part D in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 92
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.
Time frame: Baseline Part D, Week 92
Population: All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. Missing values were imputed with the last observation carried forward (LOCF) method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Baricitinib 2 mg | Change From Baseline Part D in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 92 | -0.25 Units on a Scale | Standard Deviation 1.708 |
| Part A: Baricitinib 4 mg | Change From Baseline Part D in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 92 | -0.13 Units on a Scale | Standard Deviation 3.796 |
| Part A: Baricitinib 8 mg | Change From Baseline Part D in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 92 | -0.86 Units on a Scale | Standard Deviation 2.143 |
Secondary
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])
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.
Time frame: Week 92
Population: All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | 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]) | 33.3 Percent of Participants |
| Part A: Baricitinib 2 mg | 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]) | 23.1 Percent of Participants |
| Part A: Baricitinib 4 mg | 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]) | 21.1 Percent of Participants |
| Part A: Baricitinib 8 mg | 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]) | 27.0 Percent of Participants |
Secondary
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])
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.
Time frame: Week 24
Population: All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | 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]) | 55.2 Percent of Participants |
| Part A: Baricitinib 2 mg | 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]) | 64.1 Percent of Participants |
| Part A: Baricitinib 4 mg | 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]) | 47.4 Percent of Participants |
| Part A: Baricitinib 8 mg | 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]) | 37.5 Percent of Participants |
| Part A: Baricitinib 10 mg | 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]) | 24.0 Percent of Participants |
| Part B: Partial- and Non-responder - High Dose to High Dose | 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]) | 27.9 Percent of Participants |
| Part B: Placebo Extension | 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]) | 50.0 Percent of Participants |
Secondary
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.
Time frame: Week 12
Population: All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | 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]) | 14.7 Percent of Participants |
| Part A: Baricitinib 2 mg | 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]) | 15.6 Percent of Participants |
| Part A: Baricitinib 4 mg | 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]) | 25.0 Percent of Participants |
| Part A: Baricitinib 8 mg | 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]) | 29.7 Percent of Participants |
| Part A: Baricitinib 10 mg | 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]) | 34.8 Percent of Participants |
Secondary
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.
Time frame: Week 40
Population: All randomized participants who received ≥1 dose of study drug in Part A and participated in Part C.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Percentage of Participants Experiencing Rebound Upon Discontinuation of Study Drug in Part C | 0 Percentage of Participants |
| Part A: Baricitinib 2 mg | Percentage of Participants Experiencing Rebound Upon Discontinuation of Study Drug in Part C | 0 Percentage of Participants |
| Part A: Baricitinib 4 mg | Percentage of Participants Experiencing Rebound Upon Discontinuation of Study Drug in Part C | 0 Percentage of Participants |
| Part A: Baricitinib 8 mg | Percentage of Participants Experiencing Rebound Upon Discontinuation of Study Drug in Part C | 0 Percentage of Participants |
Secondary
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
Population: All randomized participants who received ≥1 dose of study drug in Part A, had evaluable PK, and participated in Part C. Some participants received 4mg or 8 mg and increased to 8mg or 10 mg, depending on the response at week 12. Those participants are treated as separate participants in each dose group.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib | 52.4 nanomole (nM) | Geometric Coefficient of Variation 24.7 |
| Part A: Baricitinib 2 mg | Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib | 106 nanomole (nM) | Geometric Coefficient of Variation 25.9 |
| Part A: Baricitinib 4 mg | Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib | 222 nanomole (nM) | Geometric Coefficient of Variation 24.4 |
| Part A: Baricitinib 8 mg | Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib | 260 nanomole (nM) | Geometric Coefficient of Variation 22.9 |
Secondary
PK: Area Under the Concentration-Time Curve Versus Time During One Dosing Interval at Steady State (AUC τ,ss)
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
Population: All randomized participants who received ≥1 dose of study drug in Part A, had evaluable PK, and participated in Part A, B or C. Some participants received 4mg or 8 mg and increased to 8mg or 10 mg, depending on the response at week 12. Those participants are treated as separate participants in each dose group.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | PK: Area Under the Concentration-Time Curve Versus Time During One Dosing Interval at Steady State (AUC τ,ss) | 462 nanomole*hour (nM*h) | Geometric Coefficient of Variation 40.7 |
| Part A: Baricitinib 2 mg | PK: Area Under the Concentration-Time Curve Versus Time During One Dosing Interval at Steady State (AUC τ,ss) | 975 nanomole*hour (nM*h) | Geometric Coefficient of Variation 41.1 |
| Part A: Baricitinib 4 mg | PK: Area Under the Concentration-Time Curve Versus Time During One Dosing Interval at Steady State (AUC τ,ss) | 2030 nanomole*hour (nM*h) | Geometric Coefficient of Variation 43.3 |
| Part A: Baricitinib 8 mg | PK: Area Under the Concentration-Time Curve Versus Time During One Dosing Interval at Steady State (AUC τ,ss) | 2440 nanomole*hour (nM*h) | Geometric Coefficient of Variation 42.2 |