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| ID | Type | Description | Link |
|---|---|---|---|
| J2T-DM-KGAE | Other Identifier | Eli Lilly and Company | |
| DRM06-AD17 | Other Identifier | Dermira, Inc | |
| 2019-004301-28 | EudraCT Number |
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| Name | Class |
|---|---|
| Dermira, Inc. | INDUSTRY |
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This is an open-label, single arm study of 52 weeks duration. The study will assess the safety and efficacy of lebrikizumab in adolescent participants (≥12 to <18 years weighing ≥40 kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lebrikizumab 250 mg | Experimental | Participants received two subcutaneous (SC) injections of 250 milligram(mg) Lebrikizumab at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 up to (but not including) Week 52. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lebrikizumab | Biological | Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Discontinued From Study Treatment Due to Adverse Events (AEs) | The percentage of participants who discontinued from study treatment due to 1 or more AEs assessed is summarized cumulatively. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline | The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. |
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Inclusion Criteria:
Exclusion Criteria:
Participation in a prior lebrikizumab clinical study.
Treatment with the following prior to the baseline visit:
Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
Uncontrolled chronic disease that might require bursts of oral corticosteroids.
Evidence of active acute or chronic hepatitis
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
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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 |
|---|---|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | United States | ||
| Arkansas Research Trials, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37318750 | Derived | Paller AS, Flohr C, Eichenfield LF, Irvine AD, Weisman J, Soung J, Pinto Correia A, Natalie CR, Rodriguez Capriles C, Pierce E, Reifeis S, Gontijo Lima R, Armengol Tubau C, Laquer V, Weidinger S. Safety and Efficacy of Lebrikizumab in Adolescent Patients with Moderate-to-Severe Atopic Dermatitis: A 52-Week, Open-Label, Phase 3 Study. Dermatol Ther (Heidelb). 2023 Jul;13(7):1517-1534. doi: 10.1007/s13555-023-00942-y. Epub 2023 Jun 15. |
| Label | URL |
|---|---|
| Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis (ADore) | 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 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 | Lebrikizumab 250 mg | Participants received two subcutaneous (SC) injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 up to (but not including) Week 52. |
| 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 | May 12, 2020 | Sep 30, 2022 |
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| Week 52 |
| Percentage of Participants Achieving ≥75% Reduction From Baseline in Eczema Area and Severity Instrument (EASI) Score (EASI-75) | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score. | Week 52 |
| Percentage Change From Baseline in EASI Score | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). | Baseline, Week 52 |
| Percentage of Participants Achieving EASI-50 (≥50 Reduction From Baseline in EASI Score) | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 50% improvement from baseline in the EASI score. | Week 52 |
| Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score. | Week 52 |
| Change From Baseline in Body Surface Area (BSA) | The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD. | Baseline, Week 52 |
| Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Anxiety | PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. | Baseline, Week 52 |
| Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Depression | PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion Distress-Depression. Questions are measured on a 5-point scale with 1 being "Never" and 5 being "Always". Responses for each section will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service, which rescales the raw score to a standardized T-Score with a population mean of 50 and a standard deviation of 10. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. | Baseline, Week 52 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) | The DLQI questionnaire designed for participants aged 17 years or more is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. 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". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. | Baseline, Week 52 |
| Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) | The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment). | Baseline, Week 52 |
| Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab | Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab was evaluated at Week 52. | Predose: Week 52 |
| North Little Rock |
| Arkansas |
| 72117 |
| United States |
| Hope Clinical Research | Canoga Park | California | 91303 | United States |
| First OC Dermatology | Fountain Valley | California | 92708 | United States |
| MD Studies | Fountain Valley | California | 92708 | United States |
| Integrative Skin Science and Research | Sacramento | California | 95825 | United States |
| University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology | San Diego | California | 92123 | United States |
| Southern California Dermatology, Inc. | Santa Ana | California | 92701 | United States |
| IMMUNOe International Research Centers | Centennial | Colorado | 80112 | United States |
| C&R Research Services USA | Coral Gables | Florida | 33134 | United States |
| Florida Academic Centers Research and Education, LLC | Coral Gables | Florida | 33134 | United States |
| Pediatric Skin Research, LLC | Coral Gables | Florida | 33146 | United States |
| Encore Medical Research | Hollywood | Florida | 33021 | United States |
| Solutions Through Advanced Research, Inc. | Jacksonville | Florida | 32256 | United States |
| Well Pharma Medical Research Corp. | Miami | Florida | 33143 | United States |
| Sanchez Clinical Research Inc | Miami | Florida | 33157 | United States |
| Miami Dermatology and Laser Research | Miami | Florida | 33173 | United States |
| Park Avenue Dermatology | Orange Park | Florida | 32073 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613-1244 | United States |
| Georgia Pollens Clinical Research Centers, Inc | Albany | Georgia | 31707 | United States |
| Advanced Medical Research | Sandy Springs | Georgia | 30328 | United States |
| Georgia Skin & Cancer Clinic | Savannah | Georgia | 31419 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Sneeze, Wheeze, & Itch Associates LLC | Normal | Illinois | 61761 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| Kansas Medical Clinic | Topeka | Kansas | 66614 | United States |
| Skin Sciences, PLLC | Louisville | Kentucky | 40217 | United States |
| Tulane Univ School of Med | New Orleans | Louisiana | 70112 | United States |
| Dermatology and Skin Cancer Specialists | Rockville | Maryland | 20850 | United States |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | United States |
| St Joseph Dermatology and Vein Clinic | Saint Joseph | Michigan | 49085 | United States |
| Central Dermatology PC | St Louis | Missouri | 63117 | United States |
| ALLCUTIS Research | Portsmouth | New Hampshire | 03801 | United States |
| Forest Hills Dermatology Group | Kew Gardens | New York | 11415 | United States |
| Advanced Asthma and Allergy | Watertown | New York | 13601 | United States |
| Ohio Pediatric Research Association | Dayton | Ohio | 45414 | United States |
| Central States Research | Tulsa | Oklahoma | 74136 | United States |
| Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma | 74136 | United States |
| Paddington Testing Company Inc | Philadelphia | Pennsylvania | 19103 | United States |
| Arlington Research Center, Inc | Arlington | Texas | 76011 | United States |
| Encore Imaging & Medical Research | Houston | Texas | 77065 | United States |
| Cutis Wellness Dermatology | Laredo | Texas | 78041 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Acclaim Dermatology, PLLC | Sugar Land | Texas | 77497 | United States |
| Center for Clinical Studies | Webster | Texas | 77598 | United States |
| PI-Coor Clinical Research, LLC | Burke | Virginia | 22015 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | United States |
| Woden Dermatology | Phillip | Australian Capital Territory | 2606 | Australia |
| The Skin Hospital | Sydney | New South Wales | 02010 | Australia |
| The Skin Centre | Benowa | Queensland | 4217 | Australia |
| Veracity Clinical Research Pty Ltd | Woolloongabba | Queensland | 4102 | Australia |
| Sinclair Dermatology | East Melbourne | Victoria | 3002 | Australia |
| Royal Childrens Hospital Melbourne | Parkville | Victoria | 3052 | Australia |
| Burswood Dermatology | Victoria Park | Western Australia | 06100 | Australia |
| Captain Stirling Medical Centre | Nedlands | 6009 | Australia |
| Institute for Skin Advancement | Calgary | Alberta | T3A 2N1 | Canada |
| CARe Clinic | Red Deer | Alberta | T4N 6V7 | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X3 | Canada |
| The Centre for Clinical Trials, Inc | Oakville | Ontario | L6J7W5 | Canada |
| AvantDerm | Toronto | Ontario | M5A3R6 | Canada |
| Grazyna Pulka Specjalistyczny Osrodek "ALL-MED" | Krakow | Lesser Poland Voivodeship | 30-033 | Poland |
| Diamond Clinic | Krakow | Lesser Poland Voivodeship | 31-559 | Poland |
| Centrum Medyczne Evimed | Warsaw | Masovian Voivodeship | 02-625 | Poland |
| Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o. | Iwonicz-Zdrój | Podkarpackie Voivodeship | 38-440 | Poland |
| Provita Sp. z o.o | Katowice | 40-611 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie | Lublin | 20-081 | Poland |
| CityClinic Przychodnia Lekarsko-Psychologiczna | Wroclaw | 50-566 | Poland |
| Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak | Lodz | Łódź Voivodeship | 90-436 | Poland |
| Gabinet Dermatlogiczny. Beata Krecisz | Kielce | Świętokrzyskie Voivodeship | 25-155 | Poland |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled or randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lebrikizumab 250 mg | Participants received 250 mg Lebrikizumab SC at baseline and Week 2. From Week 4 onwards, all participants received 250 mg lebrikizumab SC every 2 weeks up to (but not including) Week 52. |
| 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 |
| ||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Weight | 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 | Percentage of Participants Discontinued From Study Treatment Due to Adverse Events (AEs) | The percentage of participants who discontinued from study treatment due to 1 or more AEs assessed is summarized cumulatively. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section. | All enrolled participants. | Posted | Number | percentage of participants | Week 52 |
|
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| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline | The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. | All participants with evaluable data for IGA score of 0 or 1. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 52 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving ≥75% Reduction From Baseline in Eczema Area and Severity Instrument (EASI) Score (EASI-75) | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score. | All participants with evaluable data for EASI-75. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 52 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in EASI Score | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). | All participants with evaluable data for EASI score. | Posted | Mean | 95% Confidence Interval | percentage change | Baseline, Week 52 |
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| Secondary | Percentage of Participants Achieving EASI-50 (≥50 Reduction From Baseline in EASI Score) | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 50% improvement from baseline in the EASI score. | All participants with evaluable data for EASI-50. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 52 |
|
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| Secondary | Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score. | All participants with evaluable data for EASI-90. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 52 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body Surface Area (BSA) | The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD. | All participants with evaluable data for BSA. | Posted | Mean | Standard Deviation | percentage of body surface area | Baseline, Week 52 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Anxiety | PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. | All participants with evaluable data for PROMIS Anxiety. | Posted | Mean | Standard Deviation | T-score | Baseline, Week 52 |
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| Secondary | Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Depression | PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion Distress-Depression. Questions are measured on a 5-point scale with 1 being "Never" and 5 being "Always". Responses for each section will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service, which rescales the raw score to a standardized T-Score with a population mean of 50 and a standard deviation of 10. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. | All participants evaluable data for PROMIS Depression. | Posted | Mean | Standard Deviation | T-score | Baseline, Week 52 |
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| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) | The DLQI questionnaire designed for participants aged 17 years or more is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. 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". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. | All participants with evaluable data for DLQI. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 52 |
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| Secondary | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) | The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment). | All participants with evaluable data for CDLQI. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 52 |
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| Secondary | Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab | Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab was evaluated at Week 52. | All participants with evaluable PK data at Week 52. | Posted | Mean | Standard Deviation | microgram per milliliter (μg/mL) | Predose: Week 52 |
|
|
Baseline up to Week 52
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lebrikizumab 250mg | Participants received two SC injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection Q2W from Week 4 up to (but not including) Week 52. | 1 | 206 | 5 | 206 | 133 | 206 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Testicular torsion | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Thyroglossal cyst | Congenital, familial and genetic disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Type v hyperlipidaemia | Congenital, familial and genetic disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Atopic keratoconjunctivitis | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Episcleritis | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Eyelids pruritus | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Angular cheilitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vaccination site erythema | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Multiple allergies | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Eczema herpeticum | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Herpes dermatitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Herpes ophthalmic | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Nail injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Mean cell haemoglobin concentration decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gluten sensitivity | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vitamin d deficiency | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cutaneous t-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Persistent depressive disorder | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Social anxiety disorder | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Polymenorrhoea | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Alopecia areata | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dandruff | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Milia | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Perioral dermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 8005455979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 12, 2022 | Sep 30, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C561806 | lebrikizumab |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Poland |
|
| Australia |
|
| >= 100 kg |
|
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