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

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• Psoriasis 1,899

Keywords

• Generalized Pustular Psoriasis (GPP)
• Erythrodermic Psoriasis (EP)
• Japan

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 12 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Study arms

• 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

Interventions

• DrugIxekizumab

  Administered SC

  Also known as: LY2439821

Primary outcomes

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

   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

Secondary outcomes

1. Maintenance Dosing Period: Number of Participants With GIS Grade 1: Resolved

   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

2. Maintenance Dosing Period: Number of Participants With GIS Grade 2: Improved

   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

3. Maintenance Dosing Period: Number of Participants With GIS Grade 3: Unchanged

   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

4. Maintenance Dosing Period: Number of Participants With GIS Grade 4: Worsened

   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

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

   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

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)

   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

7. Maintenance Dosing Period: Change From Baseline in Psoriasis Scalp Severity Index (PSSI) in Participants With 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).

   Time frame: Baseline, Week 20

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

   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

9. Maintenance Dosing Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score

   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

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

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

    Time frame: Week 20

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

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

    Time frame: Week 20

12. Generalized Pustular Psoriasis (GPP) Only: Change From Baseline on Generalized Pustular Psoriasis Severity Index

    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

Baseline characteristics

Publications

• Morita A, Okubo Y, Morisaki Y, Torisu-Itakura H, Umezawa Y. Ixekizumab 80 mg Every 2 Weeks Treatment Beyond Week 12 for Japanese Patients with Generalized Pustular Psoriasis and Erythrodermic Psoriasis. Dermatol Ther (Heidelb). 2022 Feb;12(2):481-494. doi: 10.1007/s13555-021-00666-x. Epub 2021 Dec 29. PubMed 34967916 ↗

Study documents

• Study protocol · Feb 1, 2019
• Statistical analysis plan · Aug 12, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr