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| ID | Type | Description | Link |
|---|---|---|---|
| I1F-IN-RHCZ | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to investigate the safety and tolerability of ixekizumab in participants in India with moderate-to-severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixekizumab - PsO With no Active PsA | Experimental | Participants with plaque psoriasis (PsO) with no active psoriatic arthritis (PsA) received:
|
|
| Ixekizumab - Active PsA | Experimental | Participants with active psoriatic arthritis (PsA) with moderate to severe plaque psoriasis (PsO) received:
Participants with active PsA without moderate to severe PsO received:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixekizumab | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs) From Week 0 to Week 24 |
| Week 0 to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| PsO With no Active PsA: Percentage of Participants With PsO Achieving ≥75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 | Participants achieving a PASI-75 without the use of other background antipsoriasis therapy were considered responders. The PASI quantifies the severity of a psoriasis based on lesion severity and the percent of body surface area (BSA) affected. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant corresponding to the region's percent BSA (0.1, 0.3, 0.2, and 0.4 for the above 4 regions, respectively). The resultant score for each anatomic region is then summed to yield the final PASI score. It ranges from 0 to 72, with higher scores reflecting greater disease severity. |
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Inclusion Criteria:
All participants:
For PsO Participants:
For PsA Participants
Exclusion Criteria:
For PsO Participants:
For PsA Participants:
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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 |
|---|---|---|---|---|---|---|
| King George Hospital | Vizag | Andhra Pradesh | 530002 | India | ||
| All India Institute of Medical Sciences |
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 European Union (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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ixekizumab - PsO With no Active PsA | Participants with plaque psoriasis (PsO) with no active psoriatic arthritis (PsA) received:
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 14, 2023 | Jul 8, 2025 |
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| Week 12 |
| PsO With no Active PsA: Percentage of PsO Participants With a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Minimal) | The sPGA is an assessment by the physician to determine participant's overall psoriatic lesions, at a given time point. For the analysis of responses, the participant's psoriasis indication is assessed on a 5-point scale as: 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe) incorporating an assessment of the severity of the three primary signs of the disease: induration, erythema, and degree of scaling. The investigator examines all of the lesions on the participant and assigns a score ranging from 0 to 5 for induration, erythema and degree of scaling. Scores for induration, erythema and scaling are then summed, and the mean of these 3 scores produces the overall sPGA score. Participants with an sPGA score of 0 (clear) or 1 (minimal) were considered responders and are reported here. | Week 12 |
| Active PsA: Percentage of Active Psoriatic Arthritis Participants Who Achieved 20% Improvement From Baseline in American College of Rheumatology 20 (ACR20) at Week 24 | The ACR 20 is defined as:
| Week 24 |
| Raipur |
| Chhattisgarh |
| 492099 |
| India |
| V.S. General Hospital | Ahmedabad | Gujarat | 380006 | India |
| Amber Clinic | Ahmedabad | Gujarat | 380015 | India |
| B. J. Medical College & Civil Hospital | Ahmedabad | Gujarat | 380016 | India |
| GMERS Medical College & Hospital | Ahmedabad | Gujarat | 380060 | India |
| Tristar Hospital | Surat | Gujarat | 395001 | India |
| Father Muller Medical College Hospital | Mangalore | Karnataka | 575002 | India |
| Dr. D. Y. Patil Medical College & Hospital | Navi Mumbai | Maharashtra | 400706 | India |
| Grant Medical Foundation - Ruby Hall Clinic | Pune | Maharashtra | 411001 | India |
| Oyster & Pearl Hospitals (Phadnis Clinic Pvt. Ltd.) | Pune | Maharashtra | 411005 | India |
| Postgraduate Institute of Medical Education & Research | Chandigarh | Punjab | 160012 | India |
| Wizderm Specialty Skin And Hair Clinic | Kolkata | West Bengal | 700017 | India |
| Medical College & Hospital | Kolkata | West Bengal | 700073 | India |
| FG001 | Ixekizumab - Active PsA | Participants with active psoriatic arthritis (PsA) with moderate to severe plaque psoriasis (PsO) received:
Participants with active PsA without moderate to severe PsO received:
|
| Received at Least One Dose of Study Drug |
|
| Q2W/Q4W Ixekizumab Dosing Regimen |
|
| Q4W Ixekizumab Dosing Regimen |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled participants who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ixekizumab - PsO With no Active PsA | Participants with plaque psoriasis (PsO) with no active psoriatic arthritis (PsA) received:
|
| BG001 | Ixekizumab - Active PsA | Participants with active psoriatic arthritis (PsA) with moderate to severe plaque psoriasis (PsO) received:
Participants with active PsA without moderate to severe PsO received:
|
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| 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 | Number of Participants Reporting Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs) From Week 0 to Week 24 |
| All participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were collected and analyzed by ixekizumab dosing regimen [that is, Q2W/Q4W and Q4W]. | Posted | Count of Participants | Participants | No | Week 0 to Week 24 |
|
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| |||||||||||||||||||||||||||||||||||
| Secondary | PsO With no Active PsA: Percentage of Participants With PsO Achieving ≥75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 | Participants achieving a PASI-75 without the use of other background antipsoriasis therapy were considered responders. The PASI quantifies the severity of a psoriasis based on lesion severity and the percent of body surface area (BSA) affected. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant corresponding to the region's percent BSA (0.1, 0.3, 0.2, and 0.4 for the above 4 regions, respectively). The resultant score for each anatomic region is then summed to yield the final PASI score. It ranges from 0 to 72, with higher scores reflecting greater disease severity. | All participants with a psoriasis indication, who do not qualify for active psoriatic arthritis (PsA) and had received at least 1 dose of study treatment. As per planned analysis, the outcome measure was planned to be analyzed for participants with plaque psoriasis (PsO) and with no active psoriatic arthritis (PsA). | Posted | Number | percentage of participant | Week 12 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | PsO With no Active PsA: Percentage of PsO Participants With a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Minimal) | The sPGA is an assessment by the physician to determine participant's overall psoriatic lesions, at a given time point. For the analysis of responses, the participant's psoriasis indication is assessed on a 5-point scale as: 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe) incorporating an assessment of the severity of the three primary signs of the disease: induration, erythema, and degree of scaling. The investigator examines all of the lesions on the participant and assigns a score ranging from 0 to 5 for induration, erythema and degree of scaling. Scores for induration, erythema and scaling are then summed, and the mean of these 3 scores produces the overall sPGA score. Participants with an sPGA score of 0 (clear) or 1 (minimal) were considered responders and are reported here. | All participants with a psoriasis indication, who do not qualify for active psoriatic arthritis (PsA) and had received at least 1 dose of study treatment. As per planned analysis, the outcome measure was planned to be analyzed for participants with plaque psoriasis (PsO) and with no active psoriatic arthritis (PsA). | Posted | Number | percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Active PsA: Percentage of Active Psoriatic Arthritis Participants Who Achieved 20% Improvement From Baseline in American College of Rheumatology 20 (ACR20) at Week 24 | The ACR 20 is defined as:
| All participants with an active psoriatic arthritis indication who received at least 1 dose of study treatment. As per planned analysis, the outcome measure was planned to be analyzed for participants with active psoriatic Arthritis. | Posted | Number | percentage of participants | Week 24 |
|
Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen [that is, Q2W/Q4W and Q4W].
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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 | Q2W/Q4W Ixekizumab Dosing Regimen | Participants from PsO with no active PsA arm and active PsA arm with moderate to severe plaque psoriasis (PsO) received Q2W/Q4W Ixekizumab dosing regimen. | 0 | 209 | 1 | 209 | 66 | 209 |
| EG001 | Q4W Ixekizumab Dosing Regimen | Participants from Active PsA arm without moderate to severe PsO who received Q4W Ixekizumab dosing regimen. | 0 | 41 | 0 | 41 | 9 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pyoderma | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Typhoid fever | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 18, 2024 | Jul 31, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| 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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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| AESIs |
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