Dermatitis, Atopic, Dermatitis, Eczema, Skin Diseases, Skin Diseases, Genetic
Conditions
Keywords
Corticosteroids
Brief summary
The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in combination with a topical corticosteroids in Japanese participants with atopic dermatitis.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have chronic Atopic Dermatitis (AD) that has been present for ≥1 year before the screening. * Have moderate-to-severe AD, including all of the following: * EASI score ≥16 at the baseline * IGA score ≥3 (scale of 0 to 4) at the baseline * AD involvement on ≥10% of Body Surface Area (BSA) at the baseline * Have a documented history provided by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening as defined by at least 1 of the following: * Inability to achieve good disease control, defined as mild disease or better (for example, IGA ≤2) after use of at least a medium-potency topical corticosteroids (TCS) for at least 4 weeks, or for the maximum duration recommended by the product prescribing information (for example, 14 days for super-potent TCS), whichever is shorter. Topical corticosteroids may be used with or without Topical calcineurin inhibitors (TCI) and/or topical Janus Kinase (JAK) inhibitors. * Participants who failed systemic therapies intended to treat AD within 6 months preceding screening, such as cyclosporine, methotrexate (MTX), azathioprine, and mycophenolate mofetil (MMF), will also be considered as surrogates for having inadequate response to topical therapy. * Body weight ≥40 kilogram (kg)
Exclusion criteria
* Have a history of anaphylaxis * Have uncontrolled chronic disease that might require bursts of oral corticosteroids for example, comorbid severe uncontrolled asthma within the past 12 months requiring systemic corticosteroid treatment or hospitalization for \>24 hours at baseline. * Have an active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline or superficial skin infections within 1 week before the baseline. * Evidence of acute or chronic hepatitis or known liver cirrhosis. * Have a history of pneumocystis pneumonia (PCP) or a positive beta-D-glucan test at screening and a confirmed diagnosis of PCP. * Have a history of human immunodeficiency virus (HIV) infection or positive HIV serology at screening. * Have presence of skin comorbidities (for example, sclerosis, psoriasis, or lupus erythematosus) that may interfere with study assessments. * Have presence of significant uncontrolled neuropsychiatric disorder. * Have been exposed to a live vaccine within 12 weeks prior to baseline or are expected to need/receive a live vaccine during the study or up to 125 days after the last dose of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 | Baseline to Week 16 | 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. |
| Percentage of Participants Achieving Eczema Area Severity Index-75 (EASI-75) (≥75% Reduction in EASI Score) at Week 16 | Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Itch Numeric Rating Scale (NRS) Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 1 | Baseline to Week 1 | The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating No itch and 10 indicating Worst itch imaginable. |
| Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 2 | Baseline to Week 2 | The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating No itch and 10 indicating Worst itch imaginable. |
| Percent Change in Eczema Area Severity Index (EASI) Score From Baseline to Week 16 | Baseline to Week 16 | 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). Least Square (LS) Mean was calculated using ANCOVA model with treatment, stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors baseline value as covariate. |
| Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 16 | Baseline to Week 16 | The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating No itch and 10 indicating Worst itch imaginable. |
| Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 4 | Baseline to Week 4 | The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating No itch and 10 indicating Worst itch imaginable. |
| Percentage of Participants Achieving EASI-90 at Week 16 | Week 16 | 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-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score. |
Countries
Japan
Participant flow
Recruitment details
Induction period (16-weeks): Participants were randomly assigned to 250mg Lebrikizumab every 2 weeks (Q2W) or 250mg Lebrikizumab every 4 weeks (Q4W) or Placebo. Maintenance period (52-weeks): At week 16, responders from 250mg Lebrikizumab Q2W were re-randomised to 250mg Lebrikizumab Q2W and 250mg Lebrikizumab Q4W; responders from 250mg Lebrikizumab Q4W or Placebo arms continued with same treatment. Responders were defined as having an IGA of 0 or 1 or a 75% reduction in EASI (EASI-75).
Pre-assignment details
(continued) Escape arm: Induction non-responder (i.e.) participants who do not achieve an IGA of 0 or 1 or an EASI-75 at Week 16 and maintenance non-responders (i.e.) those not maintaining an EASI-50 response at week 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, or 64 following week 16 were assigned to an Escape Arm and received lebrikizumab 250 mg as open-label treatment Q2W through Week 68. Throughout the trial, participants received the study drug in combination with topical corticosteroid.
Participants by arm
| Arm | Count |
|---|---|
| Induction - Placebo Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14. | 82 |
| Induction - Lebrikizumab 250 mg Q4W Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12. | 81 |
| Induction - Lebrikizumab 250 mg Q2W Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14. | 123 |
| Total | 286 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Induction Period | Adverse Event | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induction Period | Withdrawal by Subject | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Maintenance Blinded Period | Assigned Treatment by Mistake | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Maintenance Blinded Period | Enrolled to Escape Arm | 0 | 0 | 0 | 1 | 0 | 4 | 3 | 0 | 0 | 0 | 0 |
| Maintenance Blinded Period | Protocol Deviation | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Maintenance Blinded Period | Withdrawal by Subject | 0 | 0 | 0 | 1 | 2 | 1 | 2 | 0 | 0 | 0 | 0 |
| Maintenance Open Label Escape Arm | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| Maintenance Open Label Escape Arm | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 1 | 5 | 0 |
| Maintenance Open Label Escape Arm | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Maintenance Open Label Escape Arm | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Induction - Placebo | Total | Induction - Lebrikizumab 250 mg Q2W | Induction - Lebrikizumab 250 mg Q4W |
|---|---|---|---|---|
| Age, Continuous | 34.80 years STANDARD_DEVIATION 13.6 | 36.00 years STANDARD_DEVIATION 12.59 | 35.50 years STANDARD_DEVIATION 12.24 | 37.80 years STANDARD_DEVIATION 12.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 82 Participants | 286 Participants | 123 Participants | 81 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 82 Participants | 286 Participants | 123 Participants | 81 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 82 Participants | 286 Participants | 123 Participants | 81 Participants |
| Sex: Female, Male Female | 24 Participants | 90 Participants | 41 Participants | 25 Participants |
| Sex: Female, Male Male | 58 Participants | 196 Participants | 82 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 81 | 0 / 123 | 0 / 38 | 0 / 33 | 0 / 32 | 0 / 11 | 0 / 71 | 0 / 42 | 0 / 55 | 0 / 8 |
| other Total, other adverse events | 52 / 82 | 49 / 81 | 93 / 123 | 31 / 38 | 25 / 33 | 29 / 32 | 10 / 11 | 63 / 71 | 36 / 42 | 49 / 55 | 6 / 8 |
| serious Total, serious adverse events | 2 / 82 | 0 / 81 | 1 / 123 | 1 / 38 | 0 / 33 | 1 / 32 | 0 / 11 | 1 / 71 | 2 / 42 | 1 / 55 | 1 / 8 |
Outcome results
Primary
Percentage of Participants Achieving Eczema Area Severity Index-75 (EASI-75) (≥75% Reduction in EASI Score) at Week 16
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.
Time frame: Week 16
Population: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction - Placebo | Percentage of Participants Achieving Eczema Area Severity Index-75 (EASI-75) (≥75% Reduction in EASI Score) at Week 16 | 13.4 Percentage of participants |
| Induction - Lebrikizumab 250 mg Q4W | Percentage of Participants Achieving Eczema Area Severity Index-75 (EASI-75) (≥75% Reduction in EASI Score) at Week 16 | 47.2 Percentage of participants |
| Induction - Lebrikizumab 250 mg Q2W | Percentage of Participants Achieving Eczema Area Severity Index-75 (EASI-75) (≥75% Reduction in EASI Score) at Week 16 | 51.2 Percentage of participants |
p-value: <0.00195% CI: [20.6, 45.8]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [26.2, 49]Cochran-Mantel-Haenszel
Primary
Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16
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.
Time frame: Baseline to Week 16
Population: All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Markov Chain Monte Carlo Multiple Imputation (MCMC-MI) was used to handle missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction - Placebo | Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 | 6.1 Percentage of participants |
| Induction - Lebrikizumab 250 mg Q4W | Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 | 29.1 Percentage of participants |
| Induction - Lebrikizumab 250 mg Q2W | Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 | 33.4 Percentage of participants |
p-value: <0.00195% CI: [11.6, 33.6]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [17.5, 37]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Achieving EASI-90 at Week 16
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-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score.
Time frame: Week 16
Population: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction - Placebo | Percentage of Participants Achieving EASI-90 at Week 16 | 9.8 Percentage of participants |
| Induction - Lebrikizumab 250 mg Q4W | Percentage of Participants Achieving EASI-90 at Week 16 | 28.4 Percentage of participants |
| Induction - Lebrikizumab 250 mg Q2W | Percentage of Participants Achieving EASI-90 at Week 16 | 34.3 Percentage of participants |
p-value: 0.00395% CI: [6.8, 29.9]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [13.9, 34.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 16
The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating No itch and 10 indicating Worst itch imaginable.
Time frame: Baseline to Week 16
Population: All randomized participants, with a Baseline Itch NRS Score ≥4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction - Placebo | Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 16 | 3.3 Percentage of participants |
| Induction - Lebrikizumab 250 mg Q4W | Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 16 | 23.8 Percentage of participants |
| Induction - Lebrikizumab 250 mg Q2W | Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 16 | 32.7 Percentage of participants |
p-value: 0.00195% CI: [8.7, 32.4]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [17.9, 40.4]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 2
The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating No itch and 10 indicating Worst itch imaginable.
Time frame: Baseline to Week 2
Population: All randomized participants, with a Baseline Itch NRS Score ≥4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction - Placebo | Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 2 | 0 Percentage of participants |
| Induction - Lebrikizumab 250 mg Q4W | Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 2 | 1.7 Percentage of participants |
| Induction - Lebrikizumab 250 mg Q2W | Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 2 | 3.8 Percentage of participants |
p-value: 0.29495% CI: [-1.6, 5.1]Cochran-Mantel-Haenszel
p-value: 0.13895% CI: [-0.5, 7.8]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 4
The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating No itch and 10 indicating Worst itch imaginable.
Time frame: Baseline to Week 4
Population: All randomized participants, with a Baseline Itch NRS Score ≥4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction - Placebo | Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 4 | 0 Percentage of participants |
| Induction - Lebrikizumab 250 mg Q4W | Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 4 | 8.5 Percentage of participants |
| Induction - Lebrikizumab 250 mg Q2W | Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 4 | 16.3 Percentage of participants |
p-value: 0.01395% CI: [1.8, 16.5]Cochran-Mantel-Haenszel
p-value: 0.00195% CI: [8.1, 24.3]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With an Itch Numeric Rating Scale (NRS) Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 1
The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating No itch and 10 indicating Worst itch imaginable.
Time frame: Baseline to Week 1
Population: All randomized participants, with a Baseline Itch NRS Score ≥4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction - Placebo | Percentage of Participants With an Itch Numeric Rating Scale (NRS) Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 1 | 0 Percentage of participants |
| Induction - Lebrikizumab 250 mg Q4W | Percentage of Participants With an Itch Numeric Rating Scale (NRS) Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 1 | 0 Percentage of participants |
| Induction - Lebrikizumab 250 mg Q2W | Percentage of Participants With an Itch Numeric Rating Scale (NRS) Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 1 | 1.3 Percentage of participants |
p-value: 0.40495% CI: [-1.2, 3.6]Cochran-Mantel-Haenszel
Secondary
Percent Change in Eczema Area Severity Index (EASI) Score From Baseline to Week 16
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). Least Square (LS) Mean was calculated using ANCOVA model with treatment, stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors baseline value as covariate.
Time frame: Baseline to Week 16
Population: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Induction - Placebo | Percent Change in Eczema Area Severity Index (EASI) Score From Baseline to Week 16 | -25.25 Percent change | Standard Error 4.765 |
| Induction - Lebrikizumab 250 mg Q4W | Percent Change in Eczema Area Severity Index (EASI) Score From Baseline to Week 16 | -59.74 Percent change | Standard Error 4.92 |
| Induction - Lebrikizumab 250 mg Q2W | Percent Change in Eczema Area Severity Index (EASI) Score From Baseline to Week 16 | -64.23 Percent change | Standard Error 4.402 |
p-value: <0.00195% CI: [-44.1, -24.9]ANCOVA
p-value: <0.00195% CI: [-47.7, -30.3]ANCOVA