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| ID | Type | Description | Link |
|---|---|---|---|
| J4H-MC-FVAA | Other Identifier | Eli Lilly and Company | |
| 2023-504485-39-00 | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to determine the efficacy and safety of LY3972406 in adult participants with moderate-to-severe plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3972406 | Experimental | Participants received an oral dose of LY3972406 for 12 weeks. |
|
| Placebo | Placebo Comparator | Participants received an oral dose of placebo for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3972406 | Drug | Administered orally |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) |
| Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Percent Body Surface Area (BSA) | The percent BSA is the total percentage of psoriasis involvement on the participant's body surface, ranging from 0% (no involvement) to 100% (full involvement). It is measured using the handprint method, where 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The number of handprints fitting into the affected areas across the body is summed to estimate the total percentage of involvement. |
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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 on - 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 |
|---|---|---|---|---|---|---|
| Dermatology Research Associates | Los Angeles | California | 90045 | United States | ||
| Clinical Science Institute |
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 | LY3972406 | Participants received an oral dose of LY3972406 for 12 weeks. |
| FG001 | Placebo | Participants received an oral dose of placebo for 12 weeks. |
| 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 | Jul 19, 2024 | Jul 30, 2025 |
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| Drug |
Administered orally |
|
| Baseline, Week 12 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) | The DLQI is a validated, dermatology-specific, patient-reported outcomes 10-item questionnaire that evaluates participants health-related quality of life over the past week. The 10 questions are grouped into 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories and corresponding scores are:
The total score is calculated by summing all 10 question responses and has a range of 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). | Baseline, Week 12 |
| Pharmacokinetics (PK): Observed Trough Plasma Concentration of LY3972406 | Observed trough plasma concentration (Ctrough) of LY3972406. | Predose at Week 12 |
| Santa Monica |
| California |
| 90404 |
| United States |
| Driven Research | Coral Gables | Florida | 33134 | United States |
| Conquest Research | Winter Park | Florida | 32789 | United States |
| Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | 08520 | United States |
| Schweiger Dermatology Group | Hackensack | New Jersey | 07601 | United States |
| Metropolitan Dermatology - Clark | Kenilworth | New Jersey | 07033 | United States |
| Accellacare - Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Remington-Davis, Inc | Columbus | Ohio | 43215 | United States |
| DermDox Centers for Dermatology | Camp Hill | Pennsylvania | 17011 | United States |
| Center for Clinical Studies | Houston | Texas | 77004 | United States |
| Austin Institute for Clinical Research | Houston | Texas | 77056 | United States |
| Received at Least 1 Dose of the Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | LY3972406 | Participants received an oral dose of LY3972406 for 12 weeks. |
| BG001 | Placebo | Participants received an oral dose of placebo for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| 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 | Standard Deviation | years |
| |||||||||||||||
| 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 |
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| 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 | Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) |
| All randomized participants who received at least one dose of the study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
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| Secondary | Change From Baseline in Percent Body Surface Area (BSA) | The percent BSA is the total percentage of psoriasis involvement on the participant's body surface, ranging from 0% (no involvement) to 100% (full involvement). It is measured using the handprint method, where 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The number of handprints fitting into the affected areas across the body is summed to estimate the total percentage of involvement. | All randomized participants who received at least one dose of the study drug and had non-missing values for this outcome at week 12. | Posted | Least Squares Mean | Standard Error | percent BSA | Baseline, Week 12 |
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| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) | The DLQI is a validated, dermatology-specific, patient-reported outcomes 10-item questionnaire that evaluates participants health-related quality of life over the past week. The 10 questions are grouped into 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories and corresponding scores are:
The total score is calculated by summing all 10 question responses and has a range of 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). | All randomized participants who received at least one dose of the study drug and had non-missing values for this outcome at week 12. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 12 |
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| Secondary | Pharmacokinetics (PK): Observed Trough Plasma Concentration of LY3972406 | Observed trough plasma concentration (Ctrough) of LY3972406. | All randomized participants who received at least one dose of the study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter (ng/mL) | Predose at Week 12 |
|
|
From baseline to the end of follow-up (up to Week 24)
All randomized participants who received at least 1 dose of the study drug.
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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 | LY3972406 | Participants received an oral dose of LY3972406 for 12 weeks. | 0 | 16 | 0 | 16 | 9 | 16 |
| EG001 | Placebo | Participants received an oral dose of placebo for 12 weeks. | 0 | 17 | 1 | 17 | 6 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA 28.0 | Systematic Assessment |
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| Eczema eyelids | Eye disorders | MedDRA 28.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
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| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
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| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
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| Nail ridging | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 28.0 | 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 | May 2, 2024 | Jul 30, 2025 | SAP_001.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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