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| ID | Type | Description | Link |
|---|---|---|---|
| J1B-MC-FRCF | Other Identifier | Eli Lilly and Company | |
| 2019-002495-13 | EudraCT Number |
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The study was terminated for lack of efficacy after an interim analysis was performed
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The reason for this study is to see if the study drug LY3454738 is safe and effective as treatment for participants with hives that are caused by chronic spontaneous urticaria (CSU) and that are not controlled with H1-antihistamines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3454738 | Experimental | 500 milligram (mg) LY3454738 administered intravenously (IV). |
|
| Placebo | Placebo Comparator | Placebo administered IV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3454738 | Drug | Administered IV |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) | The UAS7 is the sum of the daily urticaria activity scores (UAS) over a 7-day period and ranges from 0 to 42. The daily UAS is the sum of the daily itch severity score (ISS) and daily number of hives score, and ranges from 0 to 6. The baseline UAS7 is the sum of the daily UAS over the 7 days prior to the first treatment. A higher UAS or higher UAS7 indicates greater urticaria disease activity.The ANCOVA model includes treatment as a factor and baseline UAS7 score in First 12-Week treatment period as covariates. Missing Week 12 scores will be imputed by carrying forward the participants' baseline scores (BOCF). | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7) | The ISS7 is the sum of the daily ISS over a 7-day period and ranges from 0 to 21. The daily ISS is the average of the morning and evening ISS on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The baseline ISS7 is the sum of the daily ISS over the 7 days prior to the first treatment. A higher ISS or higher ISS7 indicates more severe itching. The ANCOVA model includes treatment as a factor and baseline UAS7 score in First 12-Week treatment period as covariates. Missing Week 12 scores will be imputed by carrying forward the participants' baseline scores (BOCF). |
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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 |
|---|---|---|---|---|---|---|
| Kern Research, Inc | Bakersfield | California | 93301 | United States | ||
| First OC Dermatology |
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| Label | URL |
|---|---|
| A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence Group 1: (500 mg LY3454738, Placebo) | Participants received 500 milligram (mg) LY3454738 intravenously (IV) every 2 weeks (Q2W) for 12 weeks followed by placebo for 12 weeks. Participants did not receive study drug during the follow-up period. |
| FG001 | Sequence Group 2: (Placebo, 500 mg LY3454738) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Treatment Period |
|
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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 | Jun 10, 2020 | Oct 11, 2021 |
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| Drug |
Administered IV |
|
| Baseline, Week 12 |
| Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7) | The HSS7 is the sum of the daily number of hives over a 7-day period and ranges from 0 to 21. The daily number of hives score (also called HSS) is the average of the morning and evening number of hive scores on a four-point scale of 0 (none), 1 (between 1 and 6 hives, inclusive), 2 (between 7 and 12 hives, inclusive), and 3 (greater than 12 hives). The baseline weekly HSS7 is the sum of the HSS over the 7 days prior to the first treatment. A higher HSS or higher HSS7 indicates a greater number of hives. The ANCOVA model includes treatment as a factor and baseline UAS7 score in First 12-Week treatment period as covariates. Missing Week 12 scores will be imputed by carrying forward the participants' baseline scores (BOCF). | Baseline, Week 12 |
| Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by Baseline UAS7 (< 28 vs >= 28) Score) | The UAS7 is the sum of the daily urticaria activity scores (UAS) over a 7-day period and ranges from 0 to 42. The daily UAS is the sum of the daily itch severity score (ISS) and daily number of hives score, and ranges from 0 to 6. The baseline UAS7 is the sum of the daily UAS over the 7 days prior to the first treatment. A higher UAS or higher UAS7 indicates greater urticaria disease activity. | Week 12 |
| Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by Baseline UAS7 (< Median vs >= Median) Score) | The UAS7 is the sum of the daily urticaria activity scores (UAS) over a 7-day period and ranges from 0 to 42.The daily UAS is the sum of the daily itch severity score (ISS) and daily number of hives score, and ranges from 0 to 6. The baseline UAS7 is the sum of the daily UAS over the 7 days prior to the first treatment. A higher UAS or higher UAS7 indicates greater urticaria disease activity. | Week 12 |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 336 Hours (AUC [0-336h]) of LY3454738 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 336 Hours (AUC [0-336h]) of LY3454738 | Before Infusion, after infusion, 1 hour after infusion and 2 hours after infusion on Day 1; Before Infusion on Day 8, 15, 29, 43, 57, 71, 85, 92, 99, 113, 127, 141, 155, 169 and Post-Treatment Follow-up |
| PK: Maximum Concentration (Cmax) of LY3454738 | PK: Maximum Concentration (Cmax) of LY3454738 | Before Infusion, after infusion, 1 hour after infusion and 2 hours after infusion on Day 1; Before Infusion on Day 8, 15, 29, 43, 57, 71, 85, 92, 99, 113, 127, 141, 155, 169 and Post-Treatment Follow-up |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Antelope Valley Clinical Trials | Lancaster | California | 93534 | United States |
| California Allergy and Asthma Medical Group + Research Center | Los Angeles | California | 90025 | United States |
| Allergy & Asthma Consultants | Redwood City | California | 94063 | United States |
| Florida Center for Allergy & Asthma Research Landman | Aventura | Florida | 33180 | United States |
| Florida Center for Allergy & Asthma Research Rodicio | Miami | Florida | 33173 | United States |
| Miami Dermatology and Laser Research | Miami | Florida | 33173 | United States |
| Sarasota Clinical Research | Sarasota | Florida | 34239 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613-1244 | United States |
| University of South Florida Asthma, Allergy and Immunology | Tampa | Florida | 33613 | United States |
| Treasure Valley Medical Research | Boise | Idaho | 83706 | United States |
| Allergy & Asthma Specialists, P.S.C. | Owensboro | Kentucky | 42301 | United States |
| Johns Hopkins Asthma and Allergy Center | Baltimore | Maryland | 21224 | United States |
| Signature Allergy & Immunology | St Louis | Missouri | 63141 | United States |
| Optimed Research, LTD | Columbus | Ohio | 43235 | United States |
| Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma | 74136 | United States |
| Northwest Research Center | Portland | Oregon | 97202 | United States |
| Medizinische Hochschule Hanover | Hanover | Lower Saxony | 30625 | Germany |
| Universitätsklinikum Münster | Münster | North Rhine-Westphalia | 48149 | Germany |
| Universitatsmedizin der Johannes Gutenberg-Universitat Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Charité Campus Virchow-Klinikum | Berlin | 10117 | Germany |
| Rothhaar Studien GmbH | Berlin | 10783 | Germany |
| Diamond Clinic | Krakow | Lesser Poland Voivodeship | 31-559 | Poland |
| Centrum Medyczne Evimed | Warsaw | Masovian Voivodeship | 02-625 | Poland |
Participants received Placebo for 12 weeks followed by 500 mg LY3454738 IV Q2W for 12 weeks. Participants did not receive study drug during the follow-up period. |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
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|
| Washout Period |
|
|
| Period 2: Treatment Period (Crossover) |
|
|
| Post-treatment Follow-up |
|
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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence Group 1: (500 mg LY3454738, Placebo) | Participants received 500 mg LY3454738 intravenously (IV) every 2 weeks (Q2W) for 12 weeks followed by placebo for 12 weeks. |
| BG001 | Sequence Group 2: (Placebo, 500 mg LY3454738) | Participants received Placebo for 12 weeks followed by 500 mg LY3454738 IV Q2W 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, Categorical | Count of Participants | Participants | No |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||||
| Urticaria Activity Score Over 7 Days (UAS7) Score | The baseline UAS7 is the sum of the daily UAS over the 7 days prior to the first treatment. A higher UAS or higher UAS7 indicates greater urticaria disease activity. | Mean | Standard Deviation | units on a scale |
|
| 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 | Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) | The UAS7 is the sum of the daily urticaria activity scores (UAS) over a 7-day period and ranges from 0 to 42. The daily UAS is the sum of the daily itch severity score (ISS) and daily number of hives score, and ranges from 0 to 6. The baseline UAS7 is the sum of the daily UAS over the 7 days prior to the first treatment. A higher UAS or higher UAS7 indicates greater urticaria disease activity.The ANCOVA model includes treatment as a factor and baseline UAS7 score in First 12-Week treatment period as covariates. Missing Week 12 scores will be imputed by carrying forward the participants' baseline scores (BOCF). | All randomized participants who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
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| Secondary | Mean Change From Baseline in Itch Severity Score Over 7 Days (ISS7) | The ISS7 is the sum of the daily ISS over a 7-day period and ranges from 0 to 21. The daily ISS is the average of the morning and evening ISS on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The baseline ISS7 is the sum of the daily ISS over the 7 days prior to the first treatment. A higher ISS or higher ISS7 indicates more severe itching. The ANCOVA model includes treatment as a factor and baseline UAS7 score in First 12-Week treatment period as covariates. Missing Week 12 scores will be imputed by carrying forward the participants' baseline scores (BOCF). | All randomized participants who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
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| Secondary | Mean Change From Baseline in Hives Severity Score Over 7 Days (HSS7) | The HSS7 is the sum of the daily number of hives over a 7-day period and ranges from 0 to 21. The daily number of hives score (also called HSS) is the average of the morning and evening number of hive scores on a four-point scale of 0 (none), 1 (between 1 and 6 hives, inclusive), 2 (between 7 and 12 hives, inclusive), and 3 (greater than 12 hives). The baseline weekly HSS7 is the sum of the HSS over the 7 days prior to the first treatment. A higher HSS or higher HSS7 indicates a greater number of hives. The ANCOVA model includes treatment as a factor and baseline UAS7 score in First 12-Week treatment period as covariates. Missing Week 12 scores will be imputed by carrying forward the participants' baseline scores (BOCF). | All randomized participants who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
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| Secondary | Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by Baseline UAS7 (< 28 vs >= 28) Score) | The UAS7 is the sum of the daily urticaria activity scores (UAS) over a 7-day period and ranges from 0 to 42. The daily UAS is the sum of the daily itch severity score (ISS) and daily number of hives score, and ranges from 0 to 6. The baseline UAS7 is the sum of the daily UAS over the 7 days prior to the first treatment. A higher UAS or higher UAS7 indicates greater urticaria disease activity. | All randomized participants who received at least one dose of study drug and had UAS7 ≤6. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving Urticaria Activity Score Over 7 Days (UAS7) ≤6 (Stratified by Baseline UAS7 (< Median vs >= Median) Score) | The UAS7 is the sum of the daily urticaria activity scores (UAS) over a 7-day period and ranges from 0 to 42.The daily UAS is the sum of the daily itch severity score (ISS) and daily number of hives score, and ranges from 0 to 6. The baseline UAS7 is the sum of the daily UAS over the 7 days prior to the first treatment. A higher UAS or higher UAS7 indicates greater urticaria disease activity. | All randomized participants who received at least one dose of study drug and had UAS7 ≤6. | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 336 Hours (AUC [0-336h]) of LY3454738 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 336 Hours (AUC [0-336h]) of LY3454738 | All randomized participants who received at least one dose of LY3454738 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*hour per milliliter( ug*h/mL) | Before Infusion, after infusion, 1 hour after infusion and 2 hours after infusion on Day 1; Before Infusion on Day 8, 15, 29, 43, 57, 71, 85, 92, 99, 113, 127, 141, 155, 169 and Post-Treatment Follow-up |
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| Secondary | PK: Maximum Concentration (Cmax) of LY3454738 | PK: Maximum Concentration (Cmax) of LY3454738 | All randomized participants who received at least one dose of LY3454738 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (ug/mL) | Before Infusion, after infusion, 1 hour after infusion and 2 hours after infusion on Day 1; Before Infusion on Day 8, 15, 29, 43, 57, 71, 85, 92, 99, 113, 127, 141, 155, 169 and Post-Treatment Follow-up |
|
|
Baseline Up To 28 Weeks
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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 | 500 mg LY3454738_First 12-Week Period | Participants received 500 mg LY3454738 IV Q2W for 12 weeks. | 0 | 39 | 0 | 39 | 4 | 39 |
| EG001 | Placebo_First 12-Week Period | Participants received Placebo IV Q2W for 12 weeks. | 0 | 13 | 0 | 13 | 4 | 13 |
| EG002 | 500 LY3454738_Second 12-Week Crossover Period | Participants received 500 mg LY3454738 IV Q2W for 12 weeks. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG003 | Placebo_Second 12-Week Crossover Period | Participants received Placebo IV Q2W for 12 weeks. | 0 | 18 | 0 | 18 | 7 | 18 |
| EG004 | Follow-Up Period | Participants did not receive study drug during the follow-up period. | 0 | 38 | 0 | 38 | 2 | 38 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eczema eyelids | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sensation of foreign body | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
The study was terminated for lack of efficacy after an interim analysis was performed.
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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 | Jun 4, 2021 | Oct 11, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Withdrawal by Subject |
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| Inadvertent Enrollment |
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| Miscellaneous |
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| Inadvertent Enrollment |
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| >=65 years |
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| Male |
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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 |
|
| More than one race |
|
| Unknown or Not Reported |
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| Poland |
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| Germany |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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