Trial Outcomes & Findings for A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis (NCT NCT03942042)

Results Overview

GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

Week 12 through Week 20

Results posted on

2021-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	Ixekizumab - Generalized Pustular Psoriasis (GPP) Induction Dosing Period: Participants received 160 milligrams (mg) ixekizumab subcutaneously (SC) as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10. Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab - Erythrodermic Psoriasis (EP) Induction Dosing Period: Participants received 160 mg ixekizumab SC as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10. Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
Induction Dosing Period (12 Weeks) STARTED	7	5
Induction Dosing Period (12 Weeks) Received at Least One Dose of Study Drug	7	5
Induction Dosing Period (12 Weeks) Participants With GIS=1 at Week 12	4	0
Induction Dosing Period (12 Weeks) Participants Who Completed Week 12 With GIS >= 2	2	4
Induction Dosing Period (12 Weeks) COMPLETED	6	4
Induction Dosing Period (12 Weeks) NOT COMPLETED	1	1
Maintenance Dosing Period (8 Weeks) STARTED	2	4
Maintenance Dosing Period (8 Weeks) COMPLETED	2	4
Maintenance Dosing Period (8 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Ixekizumab - Generalized Pustular Psoriasis (GPP) Induction Dosing Period: Participants received 160 milligrams (mg) ixekizumab subcutaneously (SC) as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10. Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab - Erythrodermic Psoriasis (EP) Induction Dosing Period: Participants received 160 mg ixekizumab SC as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10. Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
Induction Dosing Period (12 Weeks) Adverse Event	0	1
Induction Dosing Period (12 Weeks) Lack of Efficacy	1	0

Baseline Characteristics

A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ixekizumab - Generalized Pustular Psoriasis (GPP) n=7 Participants Induction Dosing Period: Participants received 160 mg ixekizumab SC as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10. Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab - Erythrodermic Psoriasis (EP) n=5 Participants Induction Dosing Period: Participants received 160 mg ixekizumab SC as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10. Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Total n=12 Participants Total of all reporting groups
Age, Continuous	45.0 years STANDARD_DEVIATION 19.10 • n=5 Participants	42.2 years STANDARD_DEVIATION 14.39 • n=7 Participants	43.8 years STANDARD_DEVIATION 16.63 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Japan	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12 through Week 20

Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.

GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline.

Outcome measures

Outcome measures
Measure	Ixekizumab - Generalized Pustular Psoriasis (GPP) n=2 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab - Erythrodermic Psoriasis (EP) n=4 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
Maintenance Dosing Period: Number of Participants Who Improved Global Improvement Score (GIS) at Least 1 Point From Week 12 Through Week 20 and With ≤2 of GIS	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 20

Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.

GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline.

Outcome measures

Outcome measures
Measure	Ixekizumab - Generalized Pustular Psoriasis (GPP) n=2 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab - Erythrodermic Psoriasis (EP) n=4 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
Maintenance Dosing Period: Number of Participants With GIS Grade 1: Resolved	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 20

Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.

GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline.

Outcome measures

Outcome measures
Measure	Ixekizumab - Generalized Pustular Psoriasis (GPP) n=2 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab - Erythrodermic Psoriasis (EP) n=4 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
Maintenance Dosing Period: Number of Participants With GIS Grade 2: Improved	1 Participants	4 Participants

SECONDARY outcome

Timeframe: Week 20

Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.

GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline.

Outcome measures

Outcome measures
Measure	Ixekizumab - Generalized Pustular Psoriasis (GPP) n=2 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab - Erythrodermic Psoriasis (EP) n=4 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
Maintenance Dosing Period: Number of Participants With GIS Grade 3: Unchanged	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 20

Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.

GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline.

Outcome measures

Outcome measures
Measure	Ixekizumab - Generalized Pustular Psoriasis (GPP) n=2 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab - Erythrodermic Psoriasis (EP) n=4 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
Maintenance Dosing Period: Number of Participants With GIS Grade 4: Worsened	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 20

Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.

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 assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of psoriasis.

Outcome measures

Outcome measures
Measure	Ixekizumab - Generalized Pustular Psoriasis (GPP) n=2 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab - Erythrodermic Psoriasis (EP) n=4 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
Maintenance Dosing Period: Number of Participants Who Achieved Static Physician Global Assessment (sPGA) of (0, 1)	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 20

Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.

PASI combines assessments of the extent of body surface involvement in 4 regions (head \& neck(h), trunk(t), arms(u), legs(l)) \& severity of scaling (S), redness (R), \& plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total body surface area (BSA) affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = \>0% to \<10%, 2 = 10% to \<30%, 3 = 30% to \<50%, 4 = 50% to \<70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).

Outcome measures

Outcome measures
Measure	Ixekizumab - Generalized Pustular Psoriasis (GPP) n=2 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab - Erythrodermic Psoriasis (EP) n=4 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
Maintenance Dosing Period: Number of Participants Who Achieved at Least a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75) Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75)	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, Week 20

Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug who had Scalp Involvement at Baseline.

The scalp was assessed for erythema (redness), induration (hardness), and desquamation (shedding of skin) and percentage of area affected as follows: Erythema, Induration and Desquamation: 0 = Absent 1. = Slight 2. = Moderate 3. = Severe 4. = Severest Possible Percent of Scalp Involved: 1. = \<10% 2. = 10% - 29% 3. = 30% - 49% 4. = 50% - 69% 5. = 70% - 89% 6. = 90% - 100% The PSSI score is a composite score derived from the sum of the scores for erythema, induration and desquamation multiplied by the score for the extent of scalp area involved (percent of scalp involved). The range is 0 (no psoriasis) to 72 (Most severe Disease).

Outcome measures

Outcome measures
Measure	Ixekizumab - Generalized Pustular Psoriasis (GPP) n=1 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab - Erythrodermic Psoriasis (EP) n=4 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
Maintenance Dosing Period: Change From Baseline in Psoriasis Scalp Severity Index (PSSI) in Participants With Scalp Involvement at Baseline	-9.0 units on a scale Interval -9.0 to -9.0	-25.5 units on a scale Interval -46.0 to -15.0

SECONDARY outcome

Timeframe: Baseline, Week 20

Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.

Percentage involvement of psoriasis on each participants body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including palm, fingers and thumb).

Outcome measures

Outcome measures
Measure	Ixekizumab - Generalized Pustular Psoriasis (GPP) n=2 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab - Erythrodermic Psoriasis (EP) n=4 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
Maintenance Dosing Period: Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis Body Surface Area (BSA) Involvement of Psoriasis	-44.5 units on a scale Interval -64.0 to -25.0	-61.3 units on a scale Interval -89.0 to -7.0

SECONDARY outcome

Timeframe: Baseline, Week 20

Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.

The DLQI is a simple, patient-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all", "a little","a lot", and "very much", with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (the higher the score, the more quality of life is impaired) and a 5-point change from baseline is considered clinically relevant (Basra et al. 2008).

Outcome measures

Outcome measures
Measure	Ixekizumab - Generalized Pustular Psoriasis (GPP) n=2 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab - Erythrodermic Psoriasis (EP) n=4 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
Maintenance Dosing Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score	-4.0 score on a scale Interval -9.0 to 1.0	-6.5 score on a scale Interval -18.0 to -1.0

SECONDARY outcome

Timeframe: Week 20

Population: Maintenance Dosing Period: All participants who received at least one dose of study drug.

Number of participants who developed treatment-emergent anti-ixekizumab antibodies (TE-ADA) was summarized by treatment group.

Outcome measures

Outcome measures
Measure	Ixekizumab - Generalized Pustular Psoriasis (GPP) n=2 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab - Erythrodermic Psoriasis (EP) n=4 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
Maintenance Dosing Period: Number of Participants Who Developed Treatment-Emergent Anti-Ixekizumab Antibodies (TE-ADA)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 20

Population: Maintenance Dosing Period: All participants who received at least one dose of study drug.

Number of participants who developed neutralizing Anti-Ixekizumab antibody (NAb) was summarized by treatment group.

Outcome measures

Outcome measures
Measure	Ixekizumab - Generalized Pustular Psoriasis (GPP) n=2 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab - Erythrodermic Psoriasis (EP) n=4 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
Maintenance Dosing Period: Number of Participants Who Developed Neutralizing Anti-Ixekizumab Antibody (NAb)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 20

Population: Maintenance Dosing Period: All participants who received at least one dose of study drug in GPP arm.

GPP Severity Index was evaluated only for participants with pustular psoriasis at screening and at baseline. This is a composite score derived from the sum of scores for assessment of dermal symptoms, systemic symptoms, and laboratory findings (range, 0 to 17, with 17 representing severe symptoms). Skin symptoms were assessed by the score with the area of erythema (on a 0 to 3 scale), area of confluent pustules (on a 0 to 3 scale), and are of skin edema (on a 0 to 3 scale). The total score will be assessed (range, 0 to 9, with 9 representing severe symptoms). Systemic symptoms and laboratory findings were assessed by the score with fever (on a 0 to 2 scale), white blood cell (on a 0 to -2 scale), C-reactive protein (on a 0 to 2 scale) and Albumin (on a 0 to 2 scale). The total score will be assessed (range, 0 to 8, with 8 representing severe symptoms).

Outcome measures

Outcome measures
Measure	Ixekizumab - Generalized Pustular Psoriasis (GPP) n=2 Participants Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab - Erythrodermic Psoriasis (EP) Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
Generalized Pustular Psoriasis (GPP) Only: Change From Baseline on Generalized Pustular Psoriasis Severity Index	-2.5 units on a scale Interval -4.0 to -1.0	—

Adverse Events

Ixekizumab GPP-Induction Dosing Period

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Ixekizumab EP-Induction Dosing Period

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Ixekizumab GPP-Combined Induction and Maintenance Periods

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ixekizumab EP-Combined Induction and Maintenance Periods

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ixekizumab GPP-Induction Dosing Period n=7 participants at risk Induction Dosing Period: Participants received 160 mg ixekizumab SC as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10.	Ixekizumab EP-Induction Dosing Period n=5 participants at risk Induction Dosing Period: Participants received 160 mg ixekizumab SC as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10.	Ixekizumab GPP-Combined Induction and Maintenance Periods n=2 participants at risk Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab EP-Combined Induction and Maintenance Periods n=4 participants at risk Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
Nervous system disorders Seizure	0.00% 0/7 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Ixekizumab GPP-Induction Dosing Period n=7 participants at risk Induction Dosing Period: Participants received 160 mg ixekizumab SC as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10.	Ixekizumab EP-Induction Dosing Period n=5 participants at risk Induction Dosing Period: Participants received 160 mg ixekizumab SC as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10.	Ixekizumab GPP-Combined Induction and Maintenance Periods n=2 participants at risk Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.	Ixekizumab EP-Combined Induction and Maintenance Periods n=4 participants at risk Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.
General disorders Pyrexia	0.00% 0/7 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	14.3% 1/7 • Number of events 1 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.
Infections and infestations Paronychia	0.00% 0/7 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	14.3% 1/7 • Number of events 1 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	14.3% 1/7 • Number of events 1 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Acne	0.00% 0/7 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis contact	14.3% 1/7 • Number of events 1 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up To 20 Weeks All participants who received at least one dose of study drug.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60