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| ID | Type | Description | Link |
|---|---|---|---|
| I1F-US-RHBO | Other Identifier | Eli Lilly and Company |
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To detect onset of activity of ixekizumab in participants with moderate-to-severe plaque psoriasis and to document the same using sequential photographic images.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixekizumab Dosing Q2W | Experimental | 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q2W) every 2 weeks through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44. |
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| Ixekizumab Dosing Q4W | Experimental | 160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q4W) every 4 weeks through week 44. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixekizumab | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score | The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 Numeric Rating Score (NRS) the severity of their psoriasis "today" from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been. | Baseline through Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score | The Itch NRS is a patient-administered single-item 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 psoriasis (Ps) is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Least Square Means (LS means) are from analysis of mixed-effects model for repeated measures (MMRM) and model includes treatment group, baseline value and timepoint. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai School of Medicine Dermatology Clinical Trials | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29785237 | Background | Khattri S, Goldblum O, Solotkin K, Amir Y, Min MS, Ridenour T, Yang FE, Lebwohl M. Early Onset of Clinical Improvement with Ixekizumab in a Randomized, Open-label Study of Patients with Moderate-to-severe Plaque Psoriasis. J Clin Aesthet Dermatol. 2018 May;11(5):33-37. Epub 2018 May 1. |
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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.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Participants were randomized to ixekizumab (ixe) 80 mg Q2W or Q4W during the Induction Dosing Period from Week 0 to Week 12. Participants received ixe Q4W in the Maintenance Dosing Period from Week 12 to Week 48, and then to the Post Follow up Treatment Period for at least 12 weeks.
Induction Dosing Period (Weeks 0 up to 12), Maintenance Dosing Period (Weeks 12 up to 48), Minimum Post Treatment Follow-Up Period up to 12 weeks after last visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ixekizumab Q2W | 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q2W) every 2 weeks through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44. |
| FG001 | Ixekizumab Q4W | 160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q4W) every 4 weeks through week 44. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Induction Dosing Period |
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| Maintenance Dosing Period |
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| Post-Treatment Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ixekizumab Q2W | 160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44. |
| BG001 | Ixekizumab Q4W |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score | The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 Numeric Rating Score (NRS) the severity of their psoriasis "today" from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been. | All randomized participants. | Posted | Median | 90% Confidence Interval | Days | Baseline through Week 12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ixekizumab Q2W Induction Dosing Period | 160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C549079 | ixekizumab |
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| Baseline, Week 12 |
| Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) | 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. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). LS means are from analysis of MMRM and model includes treatment group, baseline value and timepoint. | Baseline, Week 12 |
| Mean Change From Baseline in Percent Body Surface Area (%BSA) | The BSA is the percentage involvement of psoriasis on each participant's body surface 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 the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction | Baseline, Week 12 |
| Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI) | The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in PASI scores compared to baseline. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction. | Baseline, Week 12 |
| Time to at Least a 2 Point Improvement on the PatGA Score | The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 NRS the severity of their psoriasis "today" from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been. | Baseline though Week 12 |
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| NOT COMPLETED |
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160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Ixekizumab Q4W |
160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44. |
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| Secondary | Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score | The Itch NRS is a patient-administered single-item 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 psoriasis (Ps) is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Least Square Means (LS means) are from analysis of mixed-effects model for repeated measures (MMRM) and model includes treatment group, baseline value and timepoint. | All randomized participants. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
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| Secondary | Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) | 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. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). LS means are from analysis of MMRM and model includes treatment group, baseline value and timepoint. | All randomized participants. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
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|
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| Secondary | Mean Change From Baseline in Percent Body Surface Area (%BSA) | The BSA is the percentage involvement of psoriasis on each participant's body surface 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 the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction | All randomized participants. | Posted | Least Squares Mean | Standard Error | percentage of body surface area | Baseline, Week 12 |
|
|
|
| Secondary | Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI) | The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in PASI scores compared to baseline. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction. | All randomized participants. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
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| Secondary | Time to at Least a 2 Point Improvement on the PatGA Score | The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 NRS the severity of their psoriasis "today" from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been. | All randomized participants. | Posted | Median | 90% Confidence Interval | Days | Baseline though Week 12 |
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|
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | Ixekizumab Q4W Induction Dosing Period | 160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44. | 0 | 6 | 5 | 6 |
| EG002 | Ixekizumab 80 mg Q4W Maintenance | After week 12 all participants are given 80 mg ixekizumab as a single SC injection once Q4W through week 44. | 0 | 12 | 9 | 12 |
| EG003 | Ixekizumab 80 mg Q4W Post-treatment | All participants receiving at least one dose of ixekizumab entered the post treatment follow-up period for a minimum of 12 weeks. | 0 | 12 | 1 | 12 |
| Toothache | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Injection site urticaria | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Skin bacterial infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Biopsy breast | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Biopsy prostate | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Eye laser surgery | Surgical and medical procedures | MedDRA 19.0 | Systematic Assessment |
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