Trial Outcomes & Findings for A Phase 2b Study of Baricitinib in Participants With Moderate to Severe Psoriasis (NCT NCT01490632)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

271 participants

Primary outcome timeframe

Week 12

Results posted on

2019-09-27

Participant Flow

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).

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)

Participant milestones

Participant milestones
Measure	Part A: Placebo Placebo administered orally (PO) once daily (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.	Part A: Baricitinib 2 mg Baricitinib 2 milligram (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.	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.	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.	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.	Part B: Responder - Low Dose Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.	Part B: Responder - High Dose Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.	Part B: Partial- and Non-responder - Placebo to High Dose Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.	Part B: Partial-responder - Low Dose to Low Dose Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.	Part B: Partial- and Non-responder - Low Dose to High Dose Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.	Part C: Responder - Low Dose to Placebo Baricitinib 2 mg or 4 mg PO QD re-randomized to placebo PO QD.	Part C: Responder - Low Dose to ½ Low Dose Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 1 mg or 2 mg PO QD.	Part C: Responder - High Dose to Placebo Baricitinib administered 8 mg or 10 mg PO QD re-randomized to placebo PO QD.	Part C: Responder - High Dose to Low Dose Baricitinib administered 8 mg PO QD re-randomized to baricitinib 4 mg PO QD. Baricitinib administered 10 mg PO QD re-randomized to baricitinib 4 mg PO QD.	Part D: Baricitinib 2 mg - Retreatment Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.	Part D: Baricitinib 4 mg - Retreatment Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.	Part D: Baricitinib 8 mg - Retreatment Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.	Part D: Baricitinib 10 mg - Retreatment Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Part A: Initial Treatment Period STARTED	34	32	72	64	69	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Part A: Initial Treatment Period Received at Least One Dose of Study Drug	34	32	72	64	69	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Part A: Initial Treatment Period COMPLETED	27	28	67	55	52	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Part A: Initial Treatment Period NOT COMPLETED	7	4	5	9	17	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Part B: Extension or Step-Up Period STARTED	0	0	0	0	0	29	64	19	16	50	43	8	0	0	0	0	0	0	0	0
Part B: Extension or Step-Up Period COMPLETED	0	0	0	0	0	25	51	13	6	25	22	0	0	0	0	0	0	0	0	0
Part B: Extension or Step-Up Period NOT COMPLETED	0	0	0	0	0	4	13	6	10	25	21	8	0	0	0	0	0	0	0	0
Part C: Washout or Step-Down Period STARTED	0	0	0	0	0	0	0	0	0	0	0	0	15	16	55	55	0	0	0	0
Part C: Washout or Step-Down Period COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	10	6	37	18	0	0	0	0
Part C: Washout or Step-Down Period NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	5	10	18	37	0	0	0	0
Part D: Re-Treatment Period STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	13	19	37
Part D: Re-Treatment Period COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	8	12	30
Part D: Re-Treatment Period NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	7	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Placebo Placebo administered orally (PO) once daily (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.	Part A: Baricitinib 2 mg Baricitinib 2 milligram (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.	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.	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.	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.	Part B: Responder - Low Dose Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.	Part B: Responder - High Dose Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.	Part B: Partial- and Non-responder - Placebo to High Dose Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.	Part B: Partial-responder - Low Dose to Low Dose Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.	Part B: Partial- and Non-responder - Low Dose to High Dose Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.	Part C: Responder - Low Dose to Placebo Baricitinib 2 mg or 4 mg PO QD re-randomized to placebo PO QD.	Part C: Responder - Low Dose to ½ Low Dose Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 1 mg or 2 mg PO QD.	Part C: Responder - High Dose to Placebo Baricitinib administered 8 mg or 10 mg PO QD re-randomized to placebo PO QD.	Part C: Responder - High Dose to Low Dose Baricitinib administered 8 mg PO QD re-randomized to baricitinib 4 mg PO QD. Baricitinib administered 10 mg PO QD re-randomized to baricitinib 4 mg PO QD.	Part D: Baricitinib 4 mg - Retreatment Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.	Part D: Baricitinib 8 mg - Retreatment Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.	Part D: Baricitinib 10 mg - Retreatment Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Part D: Re-Treatment Period Adverse Event	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	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	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	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	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	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	1	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Placebo n=34 Participants 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.	Part A: Baricitinib 2 mg n=32 Participants 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.	Part A: Baricitinib 4 mg n=72 Participants 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.	Part A: Baricitinib 8 mg n=64 Participants 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.	Part A: Baricitinib 10 mg n=69 Participants 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.	Total n=271 Participants Total of all reporting groups
Age, Customized	46.70 Years STANDARD_DEVIATION 15.144 • n=5 Participants	47.81 Years STANDARD_DEVIATION 15.165 • n=7 Participants	47.21 Years STANDARD_DEVIATION 11.650 • n=5 Participants	47.37 Years STANDARD_DEVIATION 15.829 • n=4 Participants	47.43 Years STANDARD_DEVIATION 10.425 • n=21 Participants	47.31 Years STANDARD_DEVIATION 13.268 • n=8 Participants
Sex/Gender, Customized Female	11 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants	18 Participants n=4 Participants	18 Participants n=21 Participants	74 Participants n=8 Participants
Sex/Gender, Customized Male	23 Participants n=5 Participants	23 Participants n=7 Participants	54 Participants n=5 Participants	46 Participants n=4 Participants	51 Participants n=21 Participants	197 Participants n=8 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants	12 Participants n=4 Participants	10 Participants n=21 Participants	43 Participants n=8 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	30 Participants n=5 Participants	26 Participants n=7 Participants	61 Participants n=5 Participants	52 Participants n=4 Participants	59 Participants n=21 Participants	228 Participants n=8 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Asian	7 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants	9 Participants n=4 Participants	11 Participants n=21 Participants	45 Participants n=8 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	7 Participants n=8 Participants
Race/Ethnicity, Customized White	26 Participants n=5 Participants	26 Participants n=7 Participants	58 Participants n=5 Participants	52 Participants n=4 Participants	53 Participants n=21 Participants	215 Participants n=8 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants
Region of Enrollment Japan	4 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	33 Participants n=8 Participants
Region of Enrollment North America	30 Participants n=5 Participants	28 Participants n=7 Participants	63 Participants n=5 Participants	56 Participants n=4 Participants	61 Participants n=21 Participants	238 Participants n=8 Participants
Duration of Psoriasis (Ps)	16.42 Years STANDARD_DEVIATION 14.297 • n=5 Participants	15.00 Years STANDARD_DEVIATION 9.951 • n=7 Participants	19.90 Years STANDARD_DEVIATION 12.766 • n=5 Participants	16.56 Years STANDARD_DEVIATION 11.948 • n=4 Participants	16.60 Years STANDARD_DEVIATION 10.653 • n=21 Participants	17.26 Years STANDARD_DEVIATION 11.995 • n=8 Participants
Percent Body Surface Area (BSA) Affected by Psoriasis	23.18 Percent of BSA STANDARD_DEVIATION 11.890 • n=5 Participants	30.78 Percent of BSA STANDARD_DEVIATION 20.523 • n=7 Participants	28.61 Percent of BSA STANDARD_DEVIATION 18.797 • n=5 Participants	28.23 Percent of BSA STANDARD_DEVIATION 15.726 • n=4 Participants	24.45 Percent of BSA STANDARD_DEVIATION 12.079 • n=21 Participants	27.04 Percent of BSA STANDARD_DEVIATION 16.101 • n=8 Participants
Baseline Psoriasis Area and Severity Index (PASI) Score	19.06 Units on a Scale STANDARD_DEVIATION 6.805 • n=5 Participants	21.36 Units on a Scale STANDARD_DEVIATION 11.056 • n=7 Participants	20.58 Units on a Scale STANDARD_DEVIATION 9.438 • n=5 Participants	20.24 Units on a Scale STANDARD_DEVIATION 7.827 • n=4 Participants	19.01 Units on a Scale STANDARD_DEVIATION 6.177 • n=21 Participants	20.00 Units on a Scale STANDARD_DEVIATION 8.228 • n=8 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=30 Participants 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.	Part A: Baricitinib 2 mg n=28 Participants 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.	Part A: Baricitinib 4 mg n=63 Participants 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.	Part A: Baricitinib 8 mg n=56 Participants 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.	Part A: Baricitinib 10 mg n=61 Participants 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.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.
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	28.6 Percent of Participants	28.6 Percent of Participants	42.9 Percent of Participants	54.1 Percent of Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=34 Participants 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.	Part A: Baricitinib 2 mg n=32 Participants 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.	Part A: Baricitinib 4 mg n=72 Participants 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.	Part A: Baricitinib 8 mg n=64 Participants 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.	Part A: Baricitinib 10 mg n=69 Participants 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.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.
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	15.6 Percent of Participants	25.0 Percent of Participants	29.7 Percent of Participants	34.8 Percent of Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=29 Participants 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.	Part A: Baricitinib 2 mg n=64 Participants 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.	Part A: Baricitinib 4 mg n=19 Participants 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.	Part A: Baricitinib 8 mg n=16 Participants 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.	Part A: Baricitinib 10 mg n=50 Participants 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.	Part B: Partial- and Non-responder - High Dose to High Dose n=43 Participants Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension n=8 Participants Placebo PO QD maintained on placebo PO QD.
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	64.1 Percent of Participants	47.4 Percent of Participants	37.5 Percent of Participants	24.0 Percent of Participants	27.9 Percent of Participants	50.0 Percent of Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=3 Participants 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.	Part A: Baricitinib 2 mg n=13 Participants 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.	Part A: Baricitinib 4 mg n=19 Participants 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.	Part A: Baricitinib 8 mg n=37 Participants 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.	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.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.
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	23.1 Percent of Participants	21.1 Percent of Participants	27.0 Percent of Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=34 Participants 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.	Part A: Baricitinib 2 mg n=32 Participants 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.	Part A: Baricitinib 4 mg n=72 Participants 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.	Part A: Baricitinib 8 mg n=64 Participants 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.	Part A: Baricitinib 10 mg n=69 Participants 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.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.
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 1.370	9.40 Units on a Scale Standard Error 1.413	9.46 Units on a Scale Standard Error 0.941	11.52 Units on a Scale Standard Error 0.997	13.93 Units on a Scale Standard Error 0.962	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=29 Participants 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.	Part A: Baricitinib 2 mg n=64 Participants 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.	Part A: Baricitinib 4 mg n=19 Participants 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.	Part A: Baricitinib 8 mg n=16 Participants 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.	Part A: Baricitinib 10 mg n=50 Participants 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.	Part B: Partial- and Non-responder - High Dose to High Dose n=43 Participants Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension n=8 Participants Placebo PO QD maintained on placebo PO QD.
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 5.480	16.69 Units on a Scale Standard Deviation 7.399	12.94 Units on a Scale Standard Deviation 6.711	12.23 Units on a Scale Standard Deviation 7.510	14.55 Units on a Scale Standard Deviation 10.493	13.67 Units on a Scale Standard Deviation 9.966	13.43 Units on a Scale Standard Deviation 5.599

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=3 Participants 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.	Part A: Baricitinib 2 mg n=13 Participants 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.	Part A: Baricitinib 4 mg n=19 Participants 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.	Part A: Baricitinib 8 mg n=37 Participants 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.	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.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.
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	3.25 Units on a Scale Standard Deviation 4.447	5.84 Units on a Scale Standard Deviation 5.544	6.98 Units on a Scale Standard Deviation 6.456	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=34 Participants 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.	Part A: Baricitinib 2 mg n=32 Participants 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.	Part A: Baricitinib 4 mg n=72 Participants 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.	Part A: Baricitinib 8 mg n=63 Participants 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.	Part A: Baricitinib 10 mg n=68 Participants 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.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.
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	-3.4 Units on a Scale Standard Error 1.00	-4.6 Units on a Scale Standard Error 0.67	-4.0 Units on a Scale Standard Error 0.71	-5.1 Units on a Scale Standard Error 0.69	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=29 Participants 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.	Part A: Baricitinib 2 mg n=64 Participants 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.	Part A: Baricitinib 4 mg n=19 Participants 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.	Part A: Baricitinib 8 mg n=16 Participants 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.	Part A: Baricitinib 10 mg n=50 Participants 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.	Part B: Partial- and Non-responder - High Dose to High Dose n=42 Participants Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension n=6 Participants Placebo PO QD maintained on placebo PO QD.
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	-7.0 Units on a Scale Standard Deviation 8.18	-3.8 Units on a Scale Standard Deviation 6.27	-1.5 Units on a Scale Standard Deviation 5.92	-7.8 Units on a Scale Standard Deviation 6.89	-4.5 Units on a Scale Standard Deviation 8.99	-3.5 Units on a Scale Standard Deviation 11.76

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=3 Participants 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.	Part A: Baricitinib 2 mg n=13 Participants 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.	Part A: Baricitinib 4 mg n=18 Participants 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.	Part A: Baricitinib 8 mg n=37 Participants 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.	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.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.
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	-0.5 Units on a Scale Standard Deviation 3.62	-2.1 Units on a Scale Standard Deviation 7.40	-5.0 Units on a Scale Standard Deviation 6.31	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=34 Participants 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.	Part A: Baricitinib 2 mg n=32 Participants 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.	Part A: Baricitinib 4 mg n=72 Participants 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.	Part A: Baricitinib 8 mg n=64 Participants 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.	Part A: Baricitinib 10 mg n=69 Participants 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.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.
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	-2.8 Units on a Scale Standard Error 0.49	-3.3 Units on a Scale Standard Error 0.33	-3.8 Units on a Scale Standard Error 0.35	-4.7 Units on a Scale Standard Error 0.34	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=29 Participants 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.	Part A: Baricitinib 2 mg n=64 Participants 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.	Part A: Baricitinib 4 mg n=19 Participants 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.	Part A: Baricitinib 8 mg n=16 Participants 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.	Part A: Baricitinib 10 mg n=49 Participants 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.	Part B: Partial- and Non-responder - High Dose to High Dose n=43 Participants Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension n=8 Participants Placebo PO QD maintained on placebo PO QD.
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	-5.6 Units on a Scale Standard Deviation 2.96	-5.4 Units on a Scale Standard Deviation 3.83	-3.4 Units on a Scale Standard Deviation 3.69	-4.1 Units on a Scale Standard Deviation 3.33	-3.5 Units on a Scale Standard Deviation 3.03	-2.5 Units on a Scale Standard Deviation 4.11

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=3 Participants 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.	Part A: Baricitinib 2 mg n=13 Participants 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.	Part A: Baricitinib 4 mg n=18 Participants 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.	Part A: Baricitinib 8 mg n=37 Participants 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.	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.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.
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	-2.5 Units on a Scale Standard Deviation 3.23	-2.7 Units on a Scale Standard Deviation 2.91	-3.1 Units on a Scale Standard Deviation 3.38	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=31 Participants 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.	Part A: Baricitinib 2 mg n=30 Participants 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.	Part A: Baricitinib 4 mg n=67 Participants 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.	Part A: Baricitinib 8 mg n=63 Participants 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.	Part A: Baricitinib 10 mg n=64 Participants 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.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.
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	-1.0 Units on a Scale Standard Error 0.58	-1.0 Units on a Scale Standard Error 0.39	-0.7 Units on a Scale Standard Error 0.40	-0.9 Units on a Scale Standard Error 0.40	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=26 Participants 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.	Part A: Baricitinib 2 mg n=57 Participants 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.	Part A: Baricitinib 4 mg n=19 Participants 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.	Part A: Baricitinib 8 mg n=14 Participants 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.	Part A: Baricitinib 10 mg n=41 Participants 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.	Part B: Partial- and Non-responder - High Dose to High Dose n=38 Participants Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension n=5 Participants Placebo PO QD maintained on placebo PO QD.
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	-2.6 Units on a Scale Standard Deviation 3.80	-1.4 Units on a Scale Standard Deviation 3.15	-1.2 Units on a Scale Standard Deviation 2.67	-1.6 Units on a Scale Standard Deviation 2.99	-2.2 Units on a Scale Standard Deviation 4.64	-3.0 Units on a Scale Standard Deviation 6.16

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	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.	Part A: Baricitinib 2 mg n=4 Participants 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.	Part A: Baricitinib 4 mg n=8 Participants 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.	Part A: Baricitinib 8 mg n=14 Participants 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.	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.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.
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	-0.13 Units on a Scale Standard Deviation 3.796	-0.86 Units on a Scale Standard Deviation 2.143	—	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=27 Participants 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.	Part A: Baricitinib 2 mg n=29 Participants 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.	Part A: Baricitinib 4 mg n=67 Participants 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.	Part A: Baricitinib 8 mg n=60 Participants 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.	Part A: Baricitinib 10 mg n=62 Participants 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.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.
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	5.7 Millimeter (mm) Standard Error 2.46	6.4 Millimeter (mm) Standard Error 1.62	9.5 Millimeter (mm) Standard Error 1.71	7.8 Millimeter (mm) Standard Error 1.69	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=28 Participants 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.	Part A: Baricitinib 2 mg n=58 Participants 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.	Part A: Baricitinib 4 mg n=19 Participants 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.	Part A: Baricitinib 8 mg n=14 Participants 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.	Part A: Baricitinib 10 mg n=42 Participants 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.	Part B: Partial- and Non-responder - High Dose to High Dose n=38 Participants Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension n=6 Participants Placebo PO QD maintained on placebo PO QD.
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	13.2 mm Standard Deviation 22.06	9.6 mm Standard Deviation 10.78	9.4 mm Standard Deviation 20.95	7.5 mm Standard Deviation 14.47	10.5 mm Standard Deviation 19.94	7.8 mm Standard Deviation 11.92

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=3 Participants 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.	Part A: Baricitinib 2 mg n=13 Participants 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.	Part A: Baricitinib 4 mg n=18 Participants 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.	Part A: Baricitinib 8 mg n=37 Participants 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.	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.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.
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	4.00 mm Standard Deviation 26.920	4.78 mm Standard Deviation 13.571	4.19 mm Standard Deviation 19.727	—	—	—

SECONDARY outcome

Timeframe: Week 40

Population: All randomized participants who received ≥1 dose of study drug in Part A and participated 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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=15 Participants 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.	Part A: Baricitinib 2 mg n=16 Participants 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.	Part A: Baricitinib 4 mg n=55 Participants 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.	Part A: Baricitinib 8 mg n=55 Participants 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.	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.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.
Percentage of Participants Experiencing Rebound Upon Discontinuation of Study Drug in Part C	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=32 Participants 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.	Part A: Baricitinib 2 mg n=72 Participants 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.	Part A: Baricitinib 4 mg n=73 Participants 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.	Part A: Baricitinib 8 mg n=78 Participants 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.	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.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.
Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib	52.4 nanomole (nM) Geometric Coefficient of Variation 24.7	106 nanomole (nM) Geometric Coefficient of Variation 25.9	222 nanomole (nM) Geometric Coefficient of Variation 24.4	260 nanomole (nM) Geometric Coefficient of Variation 22.9	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=32 Participants 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.	Part A: Baricitinib 2 mg n=72 Participants 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.	Part A: Baricitinib 4 mg n=73 Participants 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.	Part A: Baricitinib 8 mg n=78 Participants 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.	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.	Part B: Partial- and Non-responder - High Dose to High Dose Baricitinib administered 8 mg or 10 mg PO QD.	Part B: Placebo Extension Placebo PO QD maintained on placebo PO QD.
PK: Area Under the Concentration-Time Curve Versus Time During One Dosing Interval at Steady State (AUC τ,ss)	462 nanomolehour (nMh) Geometric Coefficient of Variation 40.7	975 nanomolehour (nMh) Geometric Coefficient of Variation 41.1	2030 nanomolehour (nMh) Geometric Coefficient of Variation 43.3	2440 nanomolehour (nMh) Geometric Coefficient of Variation 42.2	—	—	—

Adverse Events

Part A: Placebo

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Part A: Baricitinib 2 mg

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Part A: Baricitinib 4 mg

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Part A: Baricitinib 8 mg

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Part A: Baricitinib 10 mg

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Part B: Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part B: Low Dose

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Part B: High Dose

Serious events: 2 serious events

Other events: 41 other events

Deaths: 0 deaths

Part C: Placebo

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Part C: Baricitinib

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Part D: All Baricitinib Doses

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Follow-up: Always Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Follow-up: Ever Used Baricitinib

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Placebo n=34 participants at risk 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.	Part A: Baricitinib 2 mg n=32 participants at risk 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.	Part A: Baricitinib 4 mg n=72 participants at risk 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.	Part A: Baricitinib 8 mg n=64 participants at risk 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.	Part A: Baricitinib 10 mg n=69 participants at risk 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.	Part B: Placebo n=8 participants at risk Placebo PO QD maintained on placebo PO QD.	Part B: Low Dose n=45 participants at risk All participants in the following groups (as described in the Participant Flow): * Responder Low Dose * Partial Responder Low Dose to Low Dose groups.	Part B: High Dose n=176 participants at risk All participants in the following groups (as described in the Participant Flow): * Responder High Dose * Partial and Non-responder Placebo to High Dose * Partial and Non-responder Low Dose to High Dose * Partial and Non-responder High Dose to High Dose	Part C: Placebo n=70 participants at risk All placebo participant groups after study drug re-randomized.	Part C: Baricitinib n=71 participants at risk All baricitinib participant groups after study drug re-randomized to various doses.	Part D: All Baricitinib Doses n=72 participants at risk All participant dosages following baricitinib retreatment with Part B efficacious dose for 52 weeks.	Follow-up: Always Placebo n=8 participants at risk Participants in follow-up with exposure to placebo only during the study. No placebo received during follow-up.	Follow-up: Ever Used Baricitinib n=185 participants at risk Participants in follow-up with exposure to any dose of baricitinib during study. No baricitinib received during follow-up.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	0.00% 0/69	0.00% 0/8	0.00% 0/45	0.00% 0/176	0.00% 0/70	0.00% 0/71	1.4% 1/72 • Number of events 1	0.00% 0/8	0.00% 0/185
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	0.00% 0/69	0.00% 0/8	0.00% 0/45	0.57% 1/176 • Number of events 1	0.00% 0/70	0.00% 0/71	0.00% 0/72	0.00% 0/8	0.00% 0/185
Infections and infestations Cellulitis	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	0.00% 0/69	0.00% 0/8	0.00% 0/45	0.00% 0/176	1.4% 1/70 • Number of events 1	0.00% 0/71	0.00% 0/72	0.00% 0/8	0.00% 0/185
Infections and infestations Pneumonia	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	1.4% 1/69 • Number of events 1	0.00% 0/8	0.00% 0/45	0.00% 0/176	0.00% 0/70	0.00% 0/71	0.00% 0/72	0.00% 0/8	0.00% 0/185
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/34	0.00% 0/32	1.4% 1/72 • Number of events 1	0.00% 0/64	0.00% 0/69	0.00% 0/8	0.00% 0/45	0.00% 0/176	0.00% 0/70	0.00% 0/71	0.00% 0/72	0.00% 0/8	0.00% 0/185
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	0.00% 0/69	0.00% 0/8	0.00% 0/45	0.00% 0/176	0.00% 0/70	5.9% 1/17 • Number of events 1	0.00% 0/72	0.00% 0/8	0.00% 0/185
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/34	0.00% 0/32	0.00% 0/72	1.6% 1/64 • Number of events 1	0.00% 0/69	0.00% 0/8	0.00% 0/45	0.00% 0/176	0.00% 0/70	0.00% 0/71	0.00% 0/72	0.00% 0/8	0.00% 0/185
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	0.00% 0/69	0.00% 0/8	0.00% 0/45	0.57% 1/176 • Number of events 1	0.00% 0/70	0.00% 0/71	0.00% 0/72	0.00% 0/8	0.00% 0/185
Skin and subcutaneous tissue disorders Diabetic foot	2.9% 1/34 • Number of events 1	0.00% 0/32	0.00% 0/72	0.00% 0/64	0.00% 0/69	0.00% 0/8	0.00% 0/45	0.00% 0/176	0.00% 0/70	0.00% 0/71	0.00% 0/72	0.00% 0/8	0.00% 0/185
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/34	3.1% 1/32 • Number of events 1	0.00% 0/72	0.00% 0/64	0.00% 0/69	0.00% 0/8	0.00% 0/45	0.00% 0/176	0.00% 0/70	0.00% 0/71	0.00% 0/72	0.00% 0/8	0.00% 0/185

Other adverse events

Other adverse events
Measure	Part A: Placebo n=34 participants at risk 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.	Part A: Baricitinib 2 mg n=32 participants at risk 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.	Part A: Baricitinib 4 mg n=72 participants at risk 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.	Part A: Baricitinib 8 mg n=64 participants at risk 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.	Part A: Baricitinib 10 mg n=69 participants at risk 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.	Part B: Placebo n=8 participants at risk Placebo PO QD maintained on placebo PO QD.	Part B: Low Dose n=45 participants at risk All participants in the following groups (as described in the Participant Flow): * Responder Low Dose * Partial Responder Low Dose to Low Dose groups.	Part B: High Dose n=176 participants at risk All participants in the following groups (as described in the Participant Flow): * Responder High Dose * Partial and Non-responder Placebo to High Dose * Partial and Non-responder Low Dose to High Dose * Partial and Non-responder High Dose to High Dose	Part C: Placebo n=70 participants at risk All placebo participant groups after study drug re-randomized.	Part C: Baricitinib n=71 participants at risk All baricitinib participant groups after study drug re-randomized to various doses.	Part D: All Baricitinib Doses n=72 participants at risk All participant dosages following baricitinib retreatment with Part B efficacious dose for 52 weeks.	Follow-up: Always Placebo n=8 participants at risk Participants in follow-up with exposure to placebo only during the study. No placebo received during follow-up.	Follow-up: Ever Used Baricitinib n=185 participants at risk Participants in follow-up with exposure to any dose of baricitinib during study. No baricitinib received during follow-up.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/34	0.00% 0/32	0.00% 0/72	4.7% 3/64 • Number of events 4	0.00% 0/69	0.00% 0/8	0.00% 0/45	0.00% 0/176	1.4% 1/70 • Number of events 1	0.00% 0/71	2.8% 2/72 • Number of events 2	0.00% 0/8	0.00% 0/185
Blood and lymphatic system disorders Neutropenia	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	4.3% 3/69 • Number of events 3	0.00% 0/8	0.00% 0/45	1.1% 2/176 • Number of events 2	0.00% 0/70	0.00% 0/71	0.00% 0/72	0.00% 0/8	0.00% 0/185
Gastrointestinal disorders Abdominal discomfort	2.9% 1/34 • Number of events 1	6.2% 2/32 • Number of events 2	0.00% 0/72	3.1% 2/64 • Number of events 2	2.9% 2/69 • Number of events 2	0.00% 0/8	0.00% 0/45	0.00% 0/176	0.00% 0/70	0.00% 0/71	0.00% 0/72	0.00% 0/8	0.00% 0/185
Gastrointestinal disorders Gastric ulcer	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	0.00% 0/69	12.5% 1/8 • Number of events 1	0.00% 0/45	0.00% 0/176	0.00% 0/70	0.00% 0/71	0.00% 0/72	0.00% 0/8	0.00% 0/185
General disorders Fatigue	2.9% 1/34 • Number of events 1	6.2% 2/32 • Number of events 2	0.00% 0/72	1.6% 1/64 • Number of events 1	0.00% 0/69	0.00% 0/8	0.00% 0/45	0.57% 1/176 • Number of events 1	0.00% 0/70	0.00% 0/71	1.4% 1/72 • Number of events 1	0.00% 0/8	0.00% 0/185
Infections and infestations Herpes zoster	0.00% 0/34	0.00% 0/32	0.00% 0/72	1.6% 1/64 • Number of events 1	0.00% 0/69	0.00% 0/8	0.00% 0/45	0.57% 1/176 • Number of events 1	0.00% 0/70	1.4% 1/71 • Number of events 1	4.2% 3/72 • Number of events 3	0.00% 0/8	0.00% 0/185
Infections and infestations Influenza	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	0.00% 0/69	0.00% 0/8	0.00% 0/45	1.7% 3/176 • Number of events 3	1.4% 1/70 • Number of events 1	4.2% 3/71 • Number of events 3	4.2% 3/72 • Number of events 3	0.00% 0/8	0.00% 0/185
Infections and infestations Nasopharyngitis	11.8% 4/34 • Number of events 7	3.1% 1/32 • Number of events 1	2.8% 2/72 • Number of events 2	9.4% 6/64 • Number of events 7	8.7% 6/69 • Number of events 6	0.00% 0/8	11.1% 5/45 • Number of events 5	5.1% 9/176 • Number of events 10	4.3% 3/70 • Number of events 4	8.5% 6/71 • Number of events 6	16.7% 12/72 • Number of events 14	0.00% 0/8	1.1% 2/185 • Number of events 2
Infections and infestations Sinusitis	2.9% 1/34 • Number of events 1	3.1% 1/32 • Number of events 1	1.4% 1/72 • Number of events 1	0.00% 0/64	1.4% 1/69 • Number of events 1	0.00% 0/8	2.2% 1/45 • Number of events 1	1.7% 3/176 • Number of events 4	1.4% 1/70 • Number of events 1	0.00% 0/71	4.2% 3/72 • Number of events 3	0.00% 0/8	0.54% 1/185 • Number of events 1
Infections and infestations Upper respiratory tract infection	2.9% 1/34 • Number of events 1	3.1% 1/32 • Number of events 1	0.00% 0/72	1.6% 1/64 • Number of events 1	2.9% 2/69 • Number of events 2	0.00% 0/8	4.4% 2/45 • Number of events 3	2.8% 5/176 • Number of events 5	0.00% 0/70	1.4% 1/71 • Number of events 1	9.7% 7/72 • Number of events 10	0.00% 0/8	0.54% 1/185 • Number of events 1
Infections and infestations Urinary tract infection	2.9% 1/34 • Number of events 1	3.1% 1/32 • Number of events 1	4.2% 3/72 • Number of events 3	1.6% 1/64 • Number of events 1	2.9% 2/69 • Number of events 2	0.00% 0/8	0.00% 0/45	2.3% 4/176 • Number of events 4	1.4% 1/70 • Number of events 1	2.8% 2/71 • Number of events 2	2.8% 2/72 • Number of events 2	0.00% 0/8	1.1% 2/185 • Number of events 2
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	0.00% 0/69	0.00% 0/8	0.00% 0/45	0.00% 0/176	0.00% 0/70	0.00% 0/71	6.2% 1/16 • Number of events 1	0.00% 0/8	0.00% 0/185
Injury, poisoning and procedural complications Limb injury	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	4.3% 3/69 • Number of events 3	0.00% 0/8	0.00% 0/45	1.7% 3/176 • Number of events 3	0.00% 0/70	0.00% 0/71	1.4% 1/72 • Number of events 1	0.00% 0/8	0.00% 0/185
Injury, poisoning and procedural complications Muscle strain	0.00% 0/34	0.00% 0/32	0.00% 0/72	1.6% 1/64 • Number of events 1	0.00% 0/69	12.5% 1/8 • Number of events 1	0.00% 0/45	1.1% 2/176 • Number of events 2	0.00% 0/70	0.00% 0/71	2.8% 2/72 • Number of events 3	0.00% 0/8	0.00% 0/185
Investigations Blood creatine phosphokinase increased	0.00% 0/34	6.2% 2/32 • Number of events 2	1.4% 1/72 • Number of events 1	4.7% 3/64 • Number of events 3	7.2% 5/69 • Number of events 5	0.00% 0/8	0.00% 0/45	0.57% 1/176 • Number of events 1	0.00% 0/70	1.4% 1/71 • Number of events 1	4.2% 3/72 • Number of events 3	0.00% 0/8	0.54% 1/185 • Number of events 1
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 2/34 • Number of events 2	0.00% 0/32	1.4% 1/72 • Number of events 1	1.6% 1/64 • Number of events 1	2.9% 2/69 • Number of events 2	0.00% 0/8	0.00% 0/45	0.00% 0/176	1.4% 1/70 • Number of events 1	0.00% 0/71	2.8% 2/72 • Number of events 2	0.00% 0/8	0.00% 0/185
Musculoskeletal and connective tissue disorders Back pain	5.9% 2/34 • Number of events 2	3.1% 1/32 • Number of events 1	2.8% 2/72 • Number of events 2	1.6% 1/64 • Number of events 1	2.9% 2/69 • Number of events 2	0.00% 0/8	0.00% 0/45	1.1% 2/176 • Number of events 2	1.4% 1/70 • Number of events 1	1.4% 1/71 • Number of events 1	4.2% 3/72 • Number of events 3	0.00% 0/8	0.00% 0/185
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	1.4% 1/69 • Number of events 1	12.5% 1/8 • Number of events 1	0.00% 0/45	0.00% 0/176	0.00% 0/70	0.00% 0/71	0.00% 0/72	0.00% 0/8	0.00% 0/185
Nervous system disorders Headache	5.9% 2/34 • Number of events 2	0.00% 0/32	4.2% 3/72 • Number of events 3	7.8% 5/64 • Number of events 5	1.4% 1/69 • Number of events 1	12.5% 1/8 • Number of events 1	6.7% 3/45 • Number of events 3	4.0% 7/176 • Number of events 7	1.4% 1/70 • Number of events 1	1.4% 1/71 • Number of events 2	1.4% 1/72 • Number of events 2	0.00% 0/8	0.00% 0/185
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	0.00% 0/69	0.00% 0/8	7.7% 1/13 • Number of events 1	0.00% 0/176	0.00% 0/70	0.00% 0/71	0.00% 0/72	0.00% 0/8	0.00% 0/185
Reproductive system and breast disorders Menopausal symptoms	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	0.00% 0/69	0.00% 0/8	0.00% 0/45	0.00% 0/176	0.00% 0/70	0.00% 0/71	6.2% 1/16 • Number of events 1	0.00% 0/8	0.00% 0/185
Reproductive system and breast disorders Ovarian cyst	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	0.00% 0/69	0.00% 0/8	0.00% 0/45	0.00% 0/176	5.3% 1/19 • Number of events 1	0.00% 0/71	0.00% 0/72	0.00% 0/8	0.00% 0/185
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/34	0.00% 0/32	1.4% 1/72 • Number of events 1	0.00% 0/64	1.4% 1/69 • Number of events 1	0.00% 0/8	2.2% 1/45 • Number of events 1	1.1% 2/176 • Number of events 2	2.9% 2/70 • Number of events 2	0.00% 0/71	4.2% 3/72 • Number of events 3	0.00% 0/8	0.54% 1/185 • Number of events 1
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	1.4% 1/69 • Number of events 1	0.00% 0/8	0.00% 0/45	1.1% 2/176 • Number of events 2	0.00% 0/70	0.00% 0/71	4.2% 3/72 • Number of events 3	0.00% 0/8	0.00% 0/185
Surgical and medical procedures Hysterectomy	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	0.00% 0/69	0.00% 0/8	0.00% 0/45	0.00% 0/176	0.00% 0/70	0.00% 0/71	6.2% 1/16 • Number of events 1	0.00% 0/8	0.00% 0/185
Surgical and medical procedures Salpingo-oophorectomy bilateral	0.00% 0/34	0.00% 0/32	0.00% 0/72	0.00% 0/64	0.00% 0/69	0.00% 0/8	0.00% 0/45	0.00% 0/176	0.00% 0/70	0.00% 0/71	6.2% 1/16 • Number of events 1	0.00% 0/8	0.00% 0/185

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60