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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03942042
• Collaborator: (none)
• Enrollment: 12
• Locations: 7
• Arm: 1
• Actual Duration (Months): 12.6
• Patients Per Site: 1.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The reason for this study is to see if the study drug ixekizumab is safe and effective in participants with generalized pustular psoriasis and erythrodermic psoriasis.

Condition or Disease	Intervention/Treatment	Phase
Generalized Pustular Psoriasis; Erythrodermic Psoriasis	Drug: Ixekizumab	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open-Label, Post Marketing Clinical Trial to Evaluate the Efficacy And Safety Of Ixekizumab in Patients With Generalized Pustular Psoriasis and Erythrodermic Psoriasis
• Actual Study Start Date: Jul 5, 2019
• Actual Primary Completion Date: Jul 22, 2020
• Actual Study Completion Date: Jul 22, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Ixekizumab 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.

Drug: Ixekizumab; Administered SC; Other Names: LY2439821

Outcome Measures

Primary Outcome Measures

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 [Week 12 through Week 20]

   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.

Secondary Outcome Measures

1. Maintenance Dosing Period: Number of Participants With GIS Grade 1: Resolved [Week 20]

   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.

2. Maintenance Dosing Period: Number of Participants With GIS Grade 2: Improved [Week 20]

   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.

3. Maintenance Dosing Period: Number of Participants With GIS Grade 3: Unchanged [Week 20]

   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.

4. Maintenance Dosing Period: Number of Participants With GIS Grade 4: Worsened [Week 20]

   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.

5. Maintenance Dosing Period: Number of Participants Who Achieved Static Physician Global Assessment (sPGA) of (0, 1) [Week 20]

   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.

6. 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) [Week 20]

   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).

7. Maintenance Dosing Period: Change From Baseline in Psoriasis Scalp Severity Index (PSSI) in Participants With Scalp Involvement at Baseline [Baseline, Week 20]

   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 = Slight = Moderate = Severe = Severest Possible Percent of Scalp Involved: = <10% = 10% - 29% = 30% - 49% = 50% - 69% = 70% - 89% = 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).

8. Maintenance Dosing Period: Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis Body Surface Area (BSA) Involvement of Psoriasis [Baseline, Week 20]

   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).

9. Maintenance Dosing Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score [Baseline, Week 20]

   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).

10. Maintenance Dosing Period: Number of Participants Who Developed Treatment-Emergent Anti-Ixekizumab Antibodies (TE-ADA) [Week 20]

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

11. Maintenance Dosing Period: Number of Participants Who Developed Neutralizing Anti-Ixekizumab Antibody (NAb) [Week 20]

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

12. Generalized Pustular Psoriasis (GPP) Only: Change From Baseline on Generalized Pustular Psoriasis Severity Index [Baseline, Week 20]

    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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Present with GPP or EP based on an investigator-confirmed diagnosis and meet the associated criteria

• GPP: Meet the criteria for GPP set by Ministry of Health, Labour and Welfare (MHLW) at screening and baseline regardless of IL-36 mutation status.

• EP: Diagnosed to have BSA ≥80% involvement (with inflammatory erythema) at screening and baseline.

• Candidates for phototherapy and/or systemic therapy

• Men must agree to use a reliable method of birth control during the study

• Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

• History of drug-induced psoriasis

• Concurrent or recent use of any biologic agent

• Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study

• Have previously received ixekizumab

• Serious disorder or illness other than psoriasis

• Serious infection within the last 12 weeks

• Breastfeeding or nursing (lactating) women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nagoya City University Hospital	Nagoya	Aichi	Japan	467-8602
2	Tohoku University Hospital	Sendai-shi	Miyagi	Japan	980-8574
3	Kansai Medical University Hospital	Hirakata	Osaka	Japan	573-1191
4	Teikyo University Hospital	Itabashi-ku	Tokyo	Japan	173 8606
5	Jikei University School of Medicine	Minato-Ku	Tokyo	Japan	105-8471
6	Tokyo Medical University Hospital	Shinjuku-ku	Tokyo	Japan	160-0023
7	Osaka City University Medical School Hospital	Osaka		Japan	545-8586

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Feb 1, 2019
• Statistical Analysis Plan - Aug 12, 2020

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT03942042
• Other Study ID Numbers: 17154; I1F-JE-RHCV
• First Posted: May 8, 2019
• Last Update Posted: Aug 13, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Eli Lilly and Company: Generalized Pustular Psoriasis (GPP); Erythrodermic Psoriasis (EP); Japan
• Additional relevant MeSH terms: Psoriasis; Ixekizumab

Study Results

Participant Flow

Arm/Group Title	Ixekizumab - Generalized Pustular Psoriasis (GPP)	Ixekizumab - Erythrodermic Psoriasis (EP)
Arm/Group Description	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.	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.
Period Title: Induction Dosing Period (12 Weeks)
STARTED	7	5
Received at Least One Dose of Study Drug	7	5
Participants With GIS=1 at Week 12	4	0
Participants Who Completed Week 12 With GIS >= 2	2	4
COMPLETED	6	4
NOT COMPLETED	1	1
Period Title: Induction Dosing Period (12 Weeks)
STARTED	2	4
COMPLETED	2	4
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Ixekizumab - Generalized Pustular Psoriasis (GPP)	Ixekizumab - Erythrodermic Psoriasis (EP)	Total
Arm/Group Description	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: 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 of all reporting groups
Overall Participants	7	5	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.0 (19.10)	42.2 (14.39)	43.8 (16.63)
Sex: Female, Male (Count of Participants)
Female	4 57.1%	2 40%	6 50%
Male	3 42.9%	3 60%	6 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	7 100%	5 100%	12 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Japan	7 100%	5 100%	12 100%

Outcome Measures

1. Primary Outcome

Title	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
Description	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.
Time Frame	Week 12 through Week 20

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixekizumab - Generalized Pustular Psoriasis (GPP)	Ixekizumab - Erythrodermic Psoriasis (EP)
Arm/Group Description	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: 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.
Measure Participants	2	4
Count of Participants [Participants]	1 14.3%	0 0%

2. Secondary Outcome

Title	Maintenance Dosing Period: Number of Participants With GIS Grade 1: Resolved
Description	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.
Time Frame	Week 20

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixekizumab - Generalized Pustular Psoriasis (GPP)	Ixekizumab - Erythrodermic Psoriasis (EP)
Arm/Group Description	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: 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.
Measure Participants	2	4
Count of Participants [Participants]	1 14.3%	0 0%

3. Secondary Outcome

Title	Maintenance Dosing Period: Number of Participants With GIS Grade 2: Improved
Description	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.
Time Frame	Week 20

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixekizumab - Generalized Pustular Psoriasis (GPP)	Ixekizumab - Erythrodermic Psoriasis (EP)
Arm/Group Description	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: 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.
Measure Participants	2	4
Count of Participants [Participants]	1 14.3%	4 80%

4. Secondary Outcome

Title	Maintenance Dosing Period: Number of Participants With GIS Grade 3: Unchanged
Description	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.
Time Frame	Week 20

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixekizumab - Generalized Pustular Psoriasis (GPP)	Ixekizumab - Erythrodermic Psoriasis (EP)
Arm/Group Description	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: 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.
Measure Participants	2	4
Count of Participants [Participants]	0 0%	0 0%

5. Secondary Outcome

Title	Maintenance Dosing Period: Number of Participants With GIS Grade 4: Worsened
Description	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.
Time Frame	Week 20

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixekizumab - Generalized Pustular Psoriasis (GPP)	Ixekizumab - Erythrodermic Psoriasis (EP)
Arm/Group Description	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: 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.
Measure Participants	2	4
Count of Participants [Participants]	0 0%	0 0%

6. Secondary Outcome

Title	Maintenance Dosing Period: Number of Participants Who Achieved Static Physician Global Assessment (sPGA) of (0, 1)
Description	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.
Time Frame	Week 20

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixekizumab - Generalized Pustular Psoriasis (GPP)	Ixekizumab - Erythrodermic Psoriasis (EP)
Arm/Group Description	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: 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.
Measure Participants	2	4
Count of Participants [Participants]	2 28.6%	1 20%

7. Secondary Outcome

Title	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)
Description	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).
Time Frame	Week 20

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixekizumab - Generalized Pustular Psoriasis (GPP)	Ixekizumab - Erythrodermic Psoriasis (EP)
Arm/Group Description	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: 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.
Measure Participants	2	4
Count of Participants [Participants]	2 28.6%	3 60%

8. Secondary Outcome

Title	Maintenance Dosing Period: Change From Baseline in Psoriasis Scalp Severity Index (PSSI) in Participants With Scalp Involvement at Baseline
Description	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 = Slight = Moderate = Severe = Severest Possible Percent of Scalp Involved: = <10% = 10% - 29% = 30% - 49% = 50% - 69% = 70% - 89% = 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).
Time Frame	Baseline, Week 20

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixekizumab - Generalized Pustular Psoriasis (GPP)	Ixekizumab - Erythrodermic Psoriasis (EP)
Arm/Group Description	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: 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.
Measure Participants	1	4
Mean (Full Range) [units on a scale]	-9.0	-25.5

9. Secondary Outcome

Title	Maintenance Dosing Period: Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis Body Surface Area (BSA) Involvement of Psoriasis
Description	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).
Time Frame	Baseline, Week 20

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixekizumab - Generalized Pustular Psoriasis (GPP)	Ixekizumab - Erythrodermic Psoriasis (EP)
Arm/Group Description	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: 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.
Measure Participants	2	4
Mean (Full Range) [units on a scale]	-44.5	-61.3

10. Secondary Outcome

Title	Maintenance Dosing Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
Description	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).
Time Frame	Baseline, Week 20

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixekizumab - Generalized Pustular Psoriasis (GPP)	Ixekizumab - Erythrodermic Psoriasis (EP)
Arm/Group Description	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: 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.
Measure Participants	2	4
Mean (Full Range) [score on a scale]	-4.0	-6.5

11. Secondary Outcome

Title	Maintenance Dosing Period: Number of Participants Who Developed Treatment-Emergent Anti-Ixekizumab Antibodies (TE-ADA)
Description	Number of participants who developed treatment-emergent anti-ixekizumab antibodies (TE-ADA) was summarized by treatment group.
Time Frame	Week 20

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixekizumab - Generalized Pustular Psoriasis (GPP)	Ixekizumab - Erythrodermic Psoriasis (EP)
Arm/Group Description	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: 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.
Measure Participants	2	4
Count of Participants [Participants]	0 0%	0 0%

12. Secondary Outcome

Title	Maintenance Dosing Period: Number of Participants Who Developed Neutralizing Anti-Ixekizumab Antibody (NAb)
Description	Number of participants who developed neutralizing Anti-Ixekizumab antibody (NAb) was summarized by treatment group.
Time Frame	Week 20

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixekizumab - Generalized Pustular Psoriasis (GPP)	Ixekizumab - Erythrodermic Psoriasis (EP)
Arm/Group Description	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: 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.
Measure Participants	2	4
Count of Participants [Participants]	0 0%	0 0%

13. Secondary Outcome

Title	Generalized Pustular Psoriasis (GPP) Only: Change From Baseline on Generalized Pustular Psoriasis Severity Index
Description	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).
Time Frame	Baseline, Week 20

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixekizumab - Generalized Pustular Psoriasis (GPP)
Arm/Group Description	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.
Measure Participants	2
Mean (Full Range) [units on a scale]	-2.5

Adverse Events

Time Frame	Baseline Up To 20 Weeks
Adverse Event Reporting Description	All participants who received at least one dose of study drug.
Arm/Group Title	Ixekizumab GPP-Induction Dosing Period		Ixekizumab EP-Induction Dosing Period		Ixekizumab GPP-Combined Induction and Maintenance Periods		Ixekizumab EP-Combined Induction and Maintenance Periods
Arm/Group Description	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.		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.		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.
All Cause Mortality
	Ixekizumab GPP-Induction Dosing Period		Ixekizumab EP-Induction Dosing Period		Ixekizumab GPP-Combined Induction and Maintenance Periods		Ixekizumab EP-Combined Induction and Maintenance Periods
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/5 (0%)		0/2 (0%)		0/4 (0%)
Serious Adverse Events
	Ixekizumab GPP-Induction Dosing Period		Ixekizumab EP-Induction Dosing Period		Ixekizumab GPP-Combined Induction and Maintenance Periods		Ixekizumab EP-Combined Induction and Maintenance Periods
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		1/5 (20%)		0/2 (0%)		0/4 (0%)
Nervous system disorders
Seizure	0/7 (0%)	0	1/5 (20%)	1	0/2 (0%)	0	0/4 (0%)	0
Other (Not Including Serious) Adverse Events
	Ixekizumab GPP-Induction Dosing Period		Ixekizumab EP-Induction Dosing Period		Ixekizumab GPP-Combined Induction and Maintenance Periods		Ixekizumab EP-Combined Induction and Maintenance Periods
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/7 (57.1%)		2/5 (40%)		1/2 (50%)		3/4 (75%)
General disorders
Pyrexia	0/7 (0%)	0	0/5 (0%)	0	0/2 (0%)	0	1/4 (25%)	1
Infections and infestations
Nasopharyngitis	1/7 (14.3%)	1	1/5 (20%)	1	1/2 (50%)	1	1/4 (25%)	1
Paronychia	0/7 (0%)	0	0/5 (0%)	0	0/2 (0%)	0	1/4 (25%)	1
Upper respiratory tract infection	1/7 (14.3%)	1	0/5 (0%)	0	0/2 (0%)	0	0/4 (0%)	0
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation	1/7 (14.3%)	1	0/5 (0%)	0	0/2 (0%)	0	0/4 (0%)	0
Skin and subcutaneous tissue disorders
Acne	0/7 (0%)	0	1/5 (20%)	1	0/2 (0%)	0	1/4 (25%)	1
Dermatitis contact	1/7 (14.3%)	1	0/5 (0%)	0	0/2 (0%)	0	0/4 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.