Atopic Dermatitis
Conditions
Keywords
Eczema
Brief summary
The study will assess the safety and efficacy of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD) previously treated with Dupilumab.
Interventions
DRUGLebrikizumab
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All participants must have prior treatment with dupilumab meeting one of the following conditions: * Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab (at labeled dose level) for at least 4 months. * Participants who stopped dupilumab treatment due to intolerance or adverse events (AEs) to the drug may enter the study with no required prior length of dupilumab treatment. * Participants who stopped dupilumab treatment due to cost or loss of access to dupilumab (for example, insurance coverage) may enter the study with no required prior length of dupilumab treatment. * Participants who have chronic AD that has been present for ≥1 year before screening. * Have EASI ≥16 at baseline * Have IGA score ≥3 (Scale of 0 to 4) at baseline * Have ≥10% body surface area (BSA) of AD involvement at baseline * Have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable. * Adolescents body weight must be ≥40 kg at baseline.
Exclusion criteria
* History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening. * Have a current infection or chronic infection with hepatitis B virus (HBV) at screening (that is, positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA * Have a current infection with hepatitis C virus (HCV) at screening (that is, positive for HCV RNA * Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening, as defined by the investigator. * Have uncontrolled asthma that * might require bursts of oral or systemic corticosteroids, or * required the following due to ≥1 exacerbations within 12 months before baseline * systemic (oral and/or parenteral) corticosteroid treatment, or * hospitalization for \>24 hours. * Have known liver cirrhosis and/or chronic hepatitis of any etiology. * Had Dupilumab treatment within 4 weeks prior to baseline * Had prior treatment with tralokinumab. * Treatment with topical agents: corticosteroids, calcineurin inhibitors, Janus Kinase (JAK) inhibitors, or phosphodiesterase-4 inhibitors, such as crisaborole within 2 weeks prior to baseline * Treatment with any of the following agents within 4 weeks prior to the baseline * systemic immunosuppressive or immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants) * small molecules (e.g. JAK inhibitors) * phototherapy and photochemotherapy for AD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75) at Week 16 | Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving EASI-75 at Week 24 | Week 24 | 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. |
| Percentage of Participants With an Investigator's 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 AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on the descriptors that best describe the overall appearance of the lesions at a given time point. |
| Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 24 | Baseline to Week 24 | 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 the descriptors that best describe the overall appearance of the lesions at a given time point. |
| Percentage Change From Baseline in EASI Total Score From Baseline to Week 16 | Baseline, Week 16 | 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). |
| Percentage Change From Baseline in EASI Score From Baseline to Week 24 | Baseline, Week 24 | 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). |
| Change in EASI Score From Baseline to Week 16 | Baseline, Week 16 | 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). |
| Change in EASI Score From Baseline to Week 24 | Baseline, Week 24 | 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). |
| Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) at Week 16 | Week 16 | 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 EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score. |
| Percentage of Participants Achieving EASI-90 From Baseline to Week 24 | Baseline to Week 24 | 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 EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score. |
| Percentage of Participants With a Pruritus Numeric Rating Scale (NRS) of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 16 | Baseline to Week 16 | Pruritus NRS is 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 a Pruritus NRS of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 24 | Baseline to Week 24 | Pruritus NRS is 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 a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 16 | Baseline to Week 16 | Pruritus NRS is 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 a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 24 | Baseline to Week 24 | Pruritus NRS is 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 Change From Baseline in Pruritus NRS Score From Baseline to Week 16 | Baseline, Week 16 | Pruritus NRS is 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." Assessments were recorded daily by the participant using an electronic diary. |
| Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 24 | Baseline, Week 24 | Pruritus NRS is 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." Assessments were recorded daily by the participant using an electronic diary. |
| Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 16 | Baseline to Week 16 | Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \[0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant. |
| Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 24 | Baseline to Week 24 | Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \[0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant. |
| Change From Baseline in Sleep-Loss Scale From Baseline to Week 16 | Baseline, Week 16 | Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \[0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant. |
| Change From Baseline in Sleep-Loss Scale From Baseline to Week 24 | Baseline, Week 24 | Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \[0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant. |
| Change From Baseline in Skin Pain NRS From Baseline to Week 16 | Baseline, Week 16 | The Skin Pain NRS is an 11-point scale used by participants to rate their worst level of skin pain over the past 24 hours, with 0 indicating "no pain" and 10 indicating "worst pain imaginable." |
| Change From Baseline in Skin Pain NRS From Baseline to Week 24 | Baseline, Week 24 | The Skin Pain NRS is an 11-point scale used by participants to rate their worst level of skin pain over the past 24 hours, with 0 indicating "no pain" and 10 indicating "worst pain imaginable." |
| Change From Baseline in Dermatology Life Quality Index (DLQI) From Baseline to Week 16 | Baseline, Week 16 | The DLQI questionnaire designed for participants aged \>=16 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 and feelings, daily activities, leisure, work and school, personal relationships, 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. |
| Change From Baseline in DLQI From Baseline to Week 24 | Baseline, Week 24 | The DLQI questionnaire for participants aged 16 and above is a 10-item tool used to assess the impact of skin disease on quality of life. The 10 questions cover topics: symptoms and feelings, daily activities, leisure, work and school, personal relationships, 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 have an additional response category of "not relevant," which is scored as "0." Questions are scored from 0 to 3. Total score ranges from 0 (no impact) to 30 (maximum impact), with higher scores indicating poorer quality of life. |
| Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) From Baseline to Week 16 | Baseline, Week 16 | The CDLQI questionnaire designed for participants aged \<16 years and 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). |
| Change From Baseline in CDLQI From Baseline to Week 24 | Baseline, Week 24 | The CDLQI questionnaire designed for participants aged \<16 years and 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). |
| Percentage Change From Baseline in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16 | Baseline, Week 16 | SCORAD is validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on visual analog scale (VAS), where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7\*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease. |
| Percentage Change From Baseline in SCORAD From Baseline to Week 24 | Baseline, Week 24 | SCORAD is a validated tool for assessing the extent and intensity of AD. It consists of three components: A) the extent of AD as a percentage of each body area, with a maximum score of 100%; B) the severity of six specific symptoms (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) rated from 0 (none) to 3 (severe) for a maximum of 18 points; and C) the subjective assessment of itch and sleeplessness on a visual analog scale (VAS) from 0 (no itch/sleeplessness) to 10 (worst imaginable itch/sleeplessness) with a maximum score of 20. The total SCORAD score is calculated as A/5 + 7\*B/2 + C, ranging from 0 (no disease) to 103 (severe disease). |
Countries
United States
Contacts
STUDY_DIRECTORCall 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
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lebrikizumab 250mg Q2W Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24. | 86 |
| Total | 86 |
Baseline characteristics
| Characteristic | Lebrikizumab 250mg Q2W |
|---|---|
| Age, Continuous | 46.4 years STANDARD_DEVIATION 20 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 57 Participants |
| Region of Enrollment United States | 86 Participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 0 / 18 | 0 / 41 |
| other Total, other adverse events | 38 / 86 | 7 / 18 | 14 / 41 |
| serious Total, serious adverse events | 1 / 86 | 0 / 18 | 1 / 41 |
Outcome results
Primary
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) at Week 16
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 EASI75 responder is defined as a ≥ 75% improvement from baseline in the EASI score.
Time frame: Week 16
Population: ITT population included all enrolled participants according to their planned intervention and had Week 16 EASI 75 data. Observed Cases (OC) analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) at Week 16 | 57.4 percentage of participants |
Secondary
Change From Baseline in CDLQI From Baseline to Week 24
The CDLQI questionnaire designed for participants aged \<16 years and 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).
Time frame: Baseline, Week 24
Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had week 24 cDLQI score. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab 250mg Q2W | Change From Baseline in CDLQI From Baseline to Week 24 | -1.0 score on a scale | — |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | Change From Baseline in CDLQI From Baseline to Week 24 | -3.3 score on a scale | Standard Deviation 9.45 |
Secondary
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) From Baseline to Week 16
The CDLQI questionnaire designed for participants aged \<16 years and 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).
Time frame: Baseline, Week 16
Population: ITT population included all enrolled participants according to their planned intervention and had week 16 CDLQI score. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab 250mg Q2W | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) From Baseline to Week 16 | -3.0 score on a scale | Standard Deviation 7.96 |
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) From Baseline to Week 16
The DLQI questionnaire designed for participants aged \>=16 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 and feelings, daily activities, leisure, work and school, personal relationships, 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.
Time frame: Baseline, Week 16
Population: ITT population included all enrolled participants according to their planned intervention and had week 16 DLQI score. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab 250mg Q2W | Change From Baseline in Dermatology Life Quality Index (DLQI) From Baseline to Week 16 | -8.7 score on a scale | Standard Deviation 6.98 |
Secondary
Change From Baseline in DLQI From Baseline to Week 24
The DLQI questionnaire for participants aged 16 and above is a 10-item tool used to assess the impact of skin disease on quality of life. The 10 questions cover topics: symptoms and feelings, daily activities, leisure, work and school, personal relationships, 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 have an additional response category of not relevant, which is scored as 0. Questions are scored from 0 to 3. Total score ranges from 0 (no impact) to 30 (maximum impact), with higher scores indicating poorer quality of life.
Time frame: Baseline, Week 24
Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 to 24 of the treatment period and had week 24 DLQI score. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab 250mg Q2W | Change From Baseline in DLQI From Baseline to Week 24 | -7.5 score on a scale | Standard Deviation 7.13 |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | Change From Baseline in DLQI From Baseline to Week 24 | -9.5 score on a scale | Standard Deviation 5.83 |
Secondary
Change From Baseline in EASI Score From Baseline to Week 16
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).
Time frame: Baseline, Week 16
Population: ITT population included all enrolled participants according to their planned intervention and had Week 16 EASI data. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab 250mg Q2W | Change From Baseline in EASI Score From Baseline to Week 16 | -17.4 score on a scale | Standard Deviation 9.34 |
Secondary
Change From Baseline in EASI Score From Baseline to Week 24
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).
Time frame: Baseline, Week 24
Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had Week 24 EASI score data. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab 250mg Q2W | Change From Baseline in EASI Score From Baseline to Week 24 | -17.4 score on a scale | Standard Deviation 8.9 |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | Change From Baseline in EASI Score From Baseline to Week 24 | -19.0 score on a scale | Standard Deviation 8.29 |
Secondary
Change From Baseline in Skin Pain NRS From Baseline to Week 16
The Skin Pain NRS is an 11-point scale used by participants to rate their worst level of skin pain over the past 24 hours, with 0 indicating no pain and 10 indicating worst pain imaginable.
Time frame: Baseline, Week 16
Population: ITT population included all enrolled participants according to their planned intervention and had week 16 skin pain NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab 250mg Q2W | Change From Baseline in Skin Pain NRS From Baseline to Week 16 | -3.2 score on a scale | Standard Deviation 2.96 |
Secondary
Change From Baseline in Skin Pain NRS From Baseline to Week 24
The Skin Pain NRS is an 11-point scale used by participants to rate their worst level of skin pain over the past 24 hours, with 0 indicating no pain and 10 indicating worst pain imaginable.
Time frame: Baseline, Week 24
Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 to 24 of the treatment period and had week 24 skin pain NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab 250mg Q2W | Change From Baseline in Skin Pain NRS From Baseline to Week 24 | -2.8 score on a scale | Standard Deviation 3.51 |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | Change From Baseline in Skin Pain NRS From Baseline to Week 24 | -3.3 score on a scale | Standard Deviation 2.73 |
Secondary
Change From Baseline in Sleep-Loss Scale From Baseline to Week 16
Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \[0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.
Time frame: Baseline, Week 16
Population: ITT population included all enrolled participants according to their planned intervention and had week 16 Sleep-Loss scale score. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab 250mg Q2W | Change From Baseline in Sleep-Loss Scale From Baseline to Week 16 | -1.0 percentage of participants | Standard Deviation 1 |
Secondary
Change From Baseline in Sleep-Loss Scale From Baseline to Week 24
Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \[0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.
Time frame: Baseline, Week 24
Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had week 24 Sleep-Loss scale score. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab 250mg Q2W | Change From Baseline in Sleep-Loss Scale From Baseline to Week 24 | -0.7 percentage of participants | Standard Deviation 1.07 |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | Change From Baseline in Sleep-Loss Scale From Baseline to Week 24 | -1.1 percentage of participants | Standard Deviation 0.91 |
Secondary
Percentage Change From Baseline in EASI Score From Baseline to Week 24
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).
Time frame: Baseline, Week 24
Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had EASI score data. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage Change From Baseline in EASI Score From Baseline to Week 24 | -64.6 percentage change | Standard Deviation 23.26 |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | Percentage Change From Baseline in EASI Score From Baseline to Week 24 | -82.4 percentage change | Standard Deviation 15.93 |
Secondary
Percentage Change From Baseline in EASI Total Score From Baseline to Week 16
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).
Time frame: Baseline, Week 16
Population: ITT population included all enrolled participants according to their planned intervention and had Week 16 EASI data. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage Change From Baseline in EASI Total Score From Baseline to Week 16 | -73.3 percentage change | Standard Deviation 23.06 |
Secondary
Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 16
Pruritus NRS is 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. Assessments were recorded daily by the participant using an electronic diary.
Time frame: Baseline, Week 16
Population: ITT population included all enrolled participants according to their planned intervention and had week 16 pruritus NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 16 | -55.6 percentage change | Standard Deviation 41.78 |
Secondary
Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 24
Pruritus NRS is 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. Assessments were recorded daily by the participant using an electronic diary.
Time frame: Baseline, Week 24
Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had week 24 pruritus NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 24 | -30.0 percentage change | Standard Deviation 99.07 |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 24 | -62.0 percentage change | Standard Deviation 35.74 |
Secondary
Percentage Change From Baseline in SCORAD From Baseline to Week 24
SCORAD is a validated tool for assessing the extent and intensity of AD. It consists of three components: A) the extent of AD as a percentage of each body area, with a maximum score of 100%; B) the severity of six specific symptoms (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) rated from 0 (none) to 3 (severe) for a maximum of 18 points; and C) the subjective assessment of itch and sleeplessness on a visual analog scale (VAS) from 0 (no itch/sleeplessness) to 10 (worst imaginable itch/sleeplessness) with a maximum score of 20. The total SCORAD score is calculated as A/5 + 7\*B/2 + C, ranging from 0 (no disease) to 103 (severe disease).
Time frame: Baseline, Week 24
Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 to 24 of the treatment period and had week 24 SCORAD score. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage Change From Baseline in SCORAD From Baseline to Week 24 | -47.4 percentage change | Standard Deviation 27.07 |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | Percentage Change From Baseline in SCORAD From Baseline to Week 24 | -60.1 percentage change | Standard Deviation 23.51 |
Secondary
Percentage Change From Baseline in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16
SCORAD is validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on visual analog scale (VAS), where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7\*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease.
Time frame: Baseline, Week 16
Population: ITT population included all enrolled participants according to their planned intervention and had week 16 SCORAD score. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage Change From Baseline in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16 | -55.7 percentage change | Standard Deviation 22.46 |
Secondary
Percentage of Participants Achieving EASI 75 at Week 24
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 EASI75 responder is defined as a ≥ 75% improvement from baseline in the EASI score.
Time frame: Week 24
Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had Week 24 EASI 75 data. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage of Participants Achieving EASI 75 at Week 24 | 31.3 percentage of participants |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | Percentage of Participants Achieving EASI 75 at Week 24 | 71.8 percentage of participants |
Secondary
Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16
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 EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score.
Time frame: Baseline to Week 16
Population: ITT population included all enrolled participants according to their planned intervention and had Week 16 EASI 90 data. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16 | 29.5 percentage of participants |
Secondary
Percentage of Participants Achieving EASI-90 From Baseline to Week 24
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 EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score.
Time frame: Baseline to Week 24
Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had Week 24 EASI 90 data. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage of Participants Achieving EASI-90 From Baseline to Week 24 | 12.5 percentage of participants |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | Percentage of Participants Achieving EASI-90 From Baseline to Week 24 | 35.9 percentage of participants |
Secondary
Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 24
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 the descriptors that best describe the overall appearance of the lesions at a given time point.
Time frame: Baseline to Week 24
Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had Week 24 IGA score data. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 24 | 12.5 percentage of participants |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 24 | 48.7 percentage of participants |
Secondary
Percentage of Participants With an Investigator's 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 AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on the descriptors that best describe the overall appearance of the lesions at a given time point.
Time frame: Baseline to Week 16
Population: ITT population included all enrolled participants according to their planned intervention and had Baseline IGA of at least 2. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 | 38.7 percentage of participants |
Secondary
Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 16
Pruritus NRS is 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: ITT population included all enrolled participants according to their planned intervention and had a Baseline Pruritus NRS score of at least 3. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 16 | 72.9 percentage of participants |
Secondary
Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 24
Pruritus NRS is 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 24
Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had a \>=3-point improvement from baseline in week 24 pruritus NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 24 | 76.9 percentage of participants |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 24 | 77.8 percentage of participants |
Secondary
Percentage of Participants With a Pruritus NRS of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 24
Pruritus NRS is 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 24
Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had a \>=4-point improvement from baseline in week 24 pruritus NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage of Participants With a Pruritus NRS of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 24 | 53.8 percentage of participants |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | Percentage of Participants With a Pruritus NRS of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 24 | 65.4 percentage of participants |
Secondary
Percentage of Participants With a Pruritus Numeric Rating Scale (NRS) of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 16
Pruritus NRS is 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: ITT population included all enrolled participants according to their planned intervention and had a Baseline Pruritus NRS score of at least 4. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage of Participants With a Pruritus Numeric Rating Scale (NRS) of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 16 | 53.2 percentage of participants |
Secondary
Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 16
Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \[0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.
Time frame: Baseline to Week 16
Population: ITT population included all enrolled participants according to their planned intervention and had a baseline Sleep-Loss scale score of at least 2. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 16 | 41.7 percentage of participants |
Secondary
Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 24
Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \[0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.
Time frame: Baseline to Week 24
Population: Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 to 24 of the treatment period and had a \>=2-point improvement from baseline in week 24 Sleep-Loss scale score. OC analysis is applied here, where analysis is using all the observed data at each time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lebrikizumab 250mg Q2W | Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 24 | 40.0 percentage of participants |
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 24 | 42.9 percentage of participants |