Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06444165 | Lebrikizumab Pen Ease of Use in Participants With Atopic Dermatitis | PHASE3 | COMPLETED | 55 | — | — | Jun 4, 2024 | Jun 10, 2024 | Jul 29, 2025 | 1 | United States |
| NCT06280716 | A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis | PHASE3 | ACTIVE NOT_RECRUITING | 301 | — | — | Apr 24, 2024 | Aug 1, 2026 | Oct 15, 2025 | 46 | China, South Korea |
| NCT05735483 | A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis | PHASE3 | ENROLLING BY_INVITATION | 310 | — | — | Mar 9, 2023 | Apr 1, 2029 | May 6, 2026 | 94 | United States, Argentina +11 |
| NCT05372419 | A Study of (LY3650150) Lebrikizumab to Assess the Safety and Efficacy of Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color | PHASE3 | COMPLETED | 90 | — | — | Jan 12, 2023 | Feb 17, 2025 | Mar 9, 2026 | 36 | United States |
| NCT05369403 | A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab | PHASE3 | COMPLETED | 86 | — | — | Dec 19, 2022 | Feb 5, 2025 | Feb 25, 2026 | 37 | United States |
| NCT05559359 | A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis | PHASE3 | ACTIVE NOT_RECRUITING | 367 | — | — | Oct 18, 2022 | Dec 1, 2026 | Jan 21, 2026 | 85 | United States, Argentina +10 |
| NCT04626297 | A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA) | PHASE3 | COMPLETED | 254 | — | — | Nov 17, 2020 | Sep 30, 2022 | Oct 17, 2023 | 85 | United States |
| NCT04392154 | Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin) | PHASE3 | COMPLETED | 1,153 | — | — | Jun 15, 2020 | Apr 22, 2025 | Nov 5, 2025 | 321 | United States, Australia +14 |
| NCT04250350 | Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis | PHASE3 | COMPLETED | 206 | — | — | Feb 11, 2020 | Jun 22, 2022 | Feb 24, 2023 | 70 | United States, Australia +2 |
| NCT04250337 | Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis. | PHASE3 | COMPLETED | 228 | — | — | Feb 3, 2020 | Sep 16, 2021 | May 9, 2022 | 63 | United States, Canada +2 |
| NCT04178967 | Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis | PHASE3 | COMPLETED | 445 | — | — | Oct 29, 2019 | Apr 28, 2022 | May 24, 2023 | 89 | United States, Bulgaria +6 |
| NCT04146363 | Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1) | PHASE3 | COMPLETED | 424 | — | — | Sep 24, 2019 | May 3, 2022 | Nov 30, 2022 | 94 | United States, Australia +8 |
| NCT03443024 | A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis | PHASE2 | COMPLETED | 280 | — | — | Jan 30, 2018 | May 23, 2019 | May 4, 2021 | 58 | United States |
mSQAAQ: This modified, short questionnaire is an instrument that includes 10 questions about the ease of use and confidence in using the lebrikizumab pen. Questions: 1) Easy for me to learn how to use, 2) Easy for me to unlock, 3) Easy to hold in my hand when I inject my dose, 4) Easy to inject my dose, 5) Easy to know that my dose is complete, 7) Easy to remove needle shield/cover, 8) Easy to pick up, 9) Overall, easy to use, 11) I am confident in my ability to use the device, and 12) I am confident my dose is complete. Responses were scored on a 7-point Likert scale ranging from 'strongly disagree' to 'strongly agree' for each question. (1) Strongly disagree; (2) Disagree; (3) Slightly disagree; (4) Neither agree nor disagree; (5) Slightly agree; (6) Agree; (7) Strongly agree. A higher score indicates greater ease and confidence in using the lebrikizumab pen. This endpoint reports results for Question 9: Overall, easy to use.
mSQAAQ: This modified, short questionnaire is an instrument that includes 10 questions about the ease of use and confidence in using the lebrikizumab pen. Questions 1) Easy for me to learn how to use, 2) Easy for me to unlock, 3) Easy to hold in my hand when I inject my dose, 4) Easy to inject my dose, 5) Easy to know that my dose is complete, 7) Easy to remove needle shield/cover, 8) Easy to pick up, 9) Overall easy to use, 11) I am confident in my ability to use the device, and 12) I am confident my dose is complete. Responses were scored on a 7-point Likert scale ranging from 'strongly disagree' to 'strongly agree' for each question. (1) Strongly disagree; (2) Disagree; (3) Slightly disagree; (4) Neither agree nor disagree; (5) Slightly agree; (6) Agree; (7) Strongly agree. A higher score indicates greater ease and confidence in using the lebrikizumab pen. This endpoint reports results for Question 11: I am confident in my ability to use the device.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin 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 (none) to 72 (severe). The EASI-75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin 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-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.
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.
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. when used in combination with TCS treatment.
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) at each time point. The EASI75 responder is defined as a ≥ 75% improvement from baseline in the 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-75 responder is defined as a ≥ 75% improvement from baseline in the EASI score.
EASI-75 is a co-primary endpoint with IGA.
IGA is a co-primary endpoint with EASI-75.
Booster response to tetanus toxoid is defined as: ≥4-fold increase in anti-tetanus toxoid immunoglobulin G (IgG) antibody concentration if the pre-vaccination level was \>0.10 International units per milliliter (IU/mL) and ≤2.7 IU/mL; OR ≥2-fold increase in anti-tetanus toxoid IgG antibody concentration if the pre-vaccination level was \>2.7 IU/mL; OR ≥4-fold increase in anti-tetanus toxoid IgG antibody concentration and a post-vaccination level ≥0.10 IU/mL if the pre-vaccination level was ≤0.10 IU/mL
Positive antibody response to Meningococcus C antigen as measured by group C serum bactericidal antibodies is defined as: post-vaccination rabbit complement serum bactericidal assay (rSBA) titer ≥4 times the lower limit of quantitation (LLOQ), if the pre-vaccination rSBA titer is less than the LLOQ; OR post-vaccination rSBA titer ≥4 times the pre-vaccination titer, if the pre-vaccination rSBA titer is greater than or equal to the LLOQ.
Percentage of participants discontinued from study treatment due to adverse events is reported.
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.
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.
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (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.
The EASI assesses objective physician estimates of 2 dimensions of AD - 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-75 responder is defined as a participant who achieves a ≥ 75% reduction from baseline in the 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). Least Square (LS) Means were calculated using analysis of covariance (ANCOVA) with the factor of treatment and the baseline EASI as covariate. Note: Missing values were imputed using Markov Chain Monte Carlo (MCMC) multiple imputation.
| Arm | Type | Description |
|---|---|---|
| Lebrikizumab Pen | EXPERIMENTAL | Participants were instructed (following training by the study team via a training video) to simulate a single-dose subcutaneous (SC) injection using a pen by directly injecting into an injection pad. The prefilled pen contained active drug (250 milligrams (mg)/2 milliliters (mL) lebrikizumab). No drug was administered to the participants during this study |
| Lebrikizumab every 2 weeks (Q2W) | EXPERIMENTAL | Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of lebrikizumab as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14. Induction period includes mono cohort with only lebrikizumab and combo cohort where lebrikizumab is in combination with TCS treatment. |
| Lebrikizumab every 4 weeks (Q4W) | EXPERIMENTAL | Maintenance Period (Week 16-Week 52): Treatment from Week 16 to Week 52 is based on re-randomization of responders (from lebrikizumab Q2W arm) in the Induction Period. Participants re-randomized to the Lebrikizumab Q4W arm receive one lebrikizumab injection Q4W from Week 16 until Week 48. |
| Lebrikizumab every 8 weeks (Q8W) | EXPERIMENTAL | Maintenance Period (Week 16-Week 52): Treatment from Week 16 to Week 52 is based on re-randomization of responders (from lebrikizumab Q2W arm) in the Induction Period. Participants re-randomized to Lebrikizumab Q8W arm receive one lebrikizumab injection Q8W, with one placebo injection 4 weeks after each lebrikizumab injection from Week 16 until Week 48. |
| Escape Arm (Lebrikizumab Q2W) | EXPERIMENTAL | Maintenance Period (Week 16-Week 50): Participants who require rescue treatment for atopic dermatitis (AD) during the Induction Period, or are non-responders at Week 16, will be eligible for treatment in an Escape Arm where participants will receive open label lebrikizumab Q2W from Week 16 through Week 50. In addition, participants who do not maintain an acceptable response during the Maintenance Period (have an EASI score \<50% of baseline), will be eligible for the Escape Arm. |
| Placebo | PLACEBO_COMPARATOR | Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14. Induction period includes mono cohort with only Placebo and combo cohort where Placebo is given in combination with topical corticosteroid (TCS) treatment. Maintenance Period (Week 16-Week 52): Participants of responders at Week 16 will receive single injection of placebo every 4 weeks (Q4W) from Week 16 until Week 48. |
| Lebrikizumab | EXPERIMENTAL | Participants will receive Lebrikizumab administered subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI. |
| Lebrikizumab - Optional Extension Period (OEP) | EXPERIMENTAL | During the OEP, participants will be assigned to dose and treatment group based on participant weight and response achieved at treatment week-52. |
| Lebrikizumab 250 mg Q2W | EXPERIMENTAL | Participants received a 500 milligram (mg) loading dose of Lebrikizumab subcutaneously (SC) once every 2 weeks (Q2W) at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W | EXPERIMENTAL | Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve Investigator Global Assessment (IGA) 0 or 1 (clear or almost clear) or a 75% reduction in the Eczema Area and Severity Index (EASI) score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until Week 24. After Week 24, eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met. |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | EXPERIMENTAL | Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24. After Week 24, eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met. |
| Lebrikizumab (Cohort 1) | EXPERIMENTAL | Participants who are 6 years to \<18 years of age, 12 years to \<18 years of age who weigh \<40 kilogram (kg) or 6 years to \<12 years of age (may weigh ≥40 kg) will receive a loading dose and then subsequent doses by subcutaneous (SC) injections with a topical corticosteroid (TCS). Dosing will be based on weight. |
| Lebrikizumab (Cohort 2) | EXPERIMENTAL | Participants who are 6 months to \<6 years of age, 2 years to \<6 years of age or 6 months to \<2 years of age will receive a loading dose of lebrikizumab and then subsequent doses by SC injections with a TCS. Dosing will be based on weight. |
| Lebrikizumab Q2W (Primary Treatment Period) | EXPERIMENTAL | 250 milligrams (mg) of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks. |
| Lebrikizumab Q4W (Primary Treatment Period) | EXPERIMENTAL | 250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks. |
| Open-Label Extension Addendum: Lebrikizumab Q4W | EXPERIMENTAL | 250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 32 weeks. |
| Open-Label Extension Addendum: Lebrikizumab Q8W | EXPERIMENTAL | 250 mg of Lebrikizumab, subcutaneous injection administered every 8 weeks (Q8W) up to 32 weeks. |
| 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. |
| Lebrikizumab + Topical Corticosteroid | EXPERIMENTAL | 500 mg Lebrikizumab (2 x 250 mg) subcutaneous (SC) injections of lebrikizumab as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab every 2 weeks (Q2W) from Week 4 until Week 14. Topical corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response. |
| Placebo + Topical Corticosteroid | PLACEBO_COMPARATOR | Two placebo subcutaneous (SC) injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo every Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response |
| Lebrikizumab Q2W | EXPERIMENTAL | Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14. Maintenance Period (Week 16-Week 52): One 250 mg Lebrikizumab SC injection and one placebo SC injection as maintenance loading dose on Week 16 and Week 18. One 250 mg Lebrikizumab SC injection Q2W until Week 50. |
| Lebrikizumab Q4W | EXPERIMENTAL | Maintenance Period (Week 16-Week 52): One 250 mg Lebrikizumab SC injection and one placebo SC injection as maintenance loading dose on Week 16 and two placebo SC injections on Week 18. One 250 mg Lebrikizumab SC injection Every 4 weeks (Q4W) on Weeks 20, 24, 28, 32, 36, 40, 44, and 48. One placebo SC injection Q4W on Weeks 22, 26, 30, 34, 38, 42, 46, and 50. |
| Lebrikizumab 250 Q2W | EXPERIMENTAL | Induction Period (Baseline-Week 16): 500 milligram (mg) Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 visits followed by a single 250 mg Lebrikizumab injection Q2W from Week 4 until Week 14. Maintenance Period (Week 16-Week 52): One 250 mg Lebrikizumab SC injection Q2W until Week 50. For participants who received placebo in the Induction Period, the maintenance loading dose is: Two 250 mg Lebrikizumab SC injections on Week 16. Two 250 mg Lebrikizumab SC injections on Week 18. To maintain the blind, for participants who received Lebrikizumab in the Induction Period, the maintenance loading dose is: One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 16. One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 18. |
| Lebrikizumab 250 Q4W | EXPERIMENTAL | Maintenance Period (Week 16-Week 52): One 250 mg Lebrikizumab SC injection every 4 weeks (Q4W) on Weeks 20, 24, 28, 32, 36, 40, 44, and 48. One placebo SC injection Q4W on Weeks 22, 26, 30, 34, 38, 42, 46, and 50. For participants who received placebo in the Induction Period, the maintenance loading dose is: Two 250 mg Lebrikizumab SC injections on Week 16. Two placebo injections on Week 18. To maintain the blind, for participants who received Lebrikizumab in the Induction Period, the maintenance loading dose is: One 250 mg Lebrikizumab SC injection and one placebo SC injection on Week 16. Two placebo injections on Week 18 |
| 125 milligrams (mg) Lebrikizumab - Every 4 Weeks (Q4W) | EXPERIMENTAL | 125 mg Lebrikizumab administered subcutaneously (SC) once Q4W. Baseline: Loading dose 250 mg Lebrikizumab SC (two injections SC 1-milliliter (mL) of 125 mg/mL Lebrikizumab and 1-mL placebo). Week 2: Four 1-mL SC injections placebo. Weeks 4, 8, 12: 125 mg SC Lebrikizumab and 1-mL SC placebo. Weeks 6, 10, 14: Two 1-mL SC placebo. |
| 250 mg Lebrikizumab - Q4W | EXPERIMENTAL | 250 mg Lebrikizumab administered SC once Q4W. Baseline: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab). Week 2: Four 1-mL SC injections of placebo. Weeks 4, 8, 12: 250 mg (two 1-mL injections of 125 mg/mL Lebrikizumab). Weeks 6, 10, 14: Two 1-mL injections of placebo. |
| 250 mg Lebrikizumab - Every 2 Weeks (Q2W) | EXPERIMENTAL | 250 mg Lebrikizumab administered SC once Q2W. Baseline and Week 2: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab). Week 4, 6, 8, 10, 12, 14: 250 mg (two 1-mL SC injections of 125 mg/mL Lebrikizumab). |
| Group 4 - Placebo | PLACEBO_COMPARATOR | Placebo administered SC once Q2W. Baseline and Week 2: Four 1-mL SC injections of placebo. Week 4, 6, 8, 10, 12, 14: Two 1-mL SC injections of placebo. |
| Name | Type | Description |
|---|---|---|
| Lebrikizumab Pen | DRUG | Injected into a practice pad. |
| Placebo | DRUG | Subcutaneous injection |
| Lebrikizumab | DRUG | Subcutaneous injection |
| Topical Corticosteroid | DRUG | Topical Corticosteroid |
| Topical Corticosteroid (TCS) | DRUG | TCS administered |
Inclusion Criteria: * Self-report being diagnosed with atopic dermatitis (AD) by a physician and able to provide approximate diagnosis date. * Autoinjector or Pen naïve \[have not used an autoinjector or pen previously; permissible to have used a pre-filled syringe (PFS) or vial and syringe\]. * Wi...