A Phase 2 interventional study of Lebrikizumab and Placebo in Atopic Dermatitis, sponsored by Eli Lilly and Company. Completed at 58 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-04.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
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Among 24 studies testing lebrikizumab in Dermatitis, Atopic — 4 open to participants now, 7 under way, 4 of them phase 3. lebrikizumab · Dermatitis, Atopic.
Among the 24 studies testing lebrikizumab in Dermatitis, Atopic, this one is the 10th largest by enrollment, is the only one that started in 2018, is one of 3 in phase 2, and was the 3rd registered.
1,592 studies on the registry are indexed under Dermatitis, Atopic; 287 are open to participants now.
Browse Dermatitis, Atopic studies →4 of the 24 studies testing lebrikizumab in Dermatitis, Atopic are open now, in 12 countries. Recruiting first, the newest first:
Eli Lilly and Company · Sites in United States, Argentina, Australia and 10 more countries
Ages 6 mo–18 yrs
Forefront Dermatology S.C · Sites in United States
Ages 12+
Almirall, S.A.
Ages 12+
University of California, San Francisco · Sites in United States
Ages 18+
By country, each count listing its studies:
lebrikizumab: first FDA approval 2024 (EBGLYSS), first EMA approval 2023. What it is approved for, and how studies give it, is on its page →
Of the 195 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 96 (49%) stop at 75 or younger; 94 take children under 18; 52 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 280 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Median enrollment 252 across the 24 interventional studies. Of the 17 that completed or were terminated, 13 (76%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 24 have an industry lead sponsor. The 6 most frequent:
Eli Lilly and Company is the lead sponsor of 2,108 studies on the registry; 153 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 358 (67%) have results posted.
30 studies in Dermatitis, Atopic by Eli Lilly and Company: 1 open now, 2 under way, 2 of them phase 3. Of 28 finished, 25 (89%) have results posted.
Among the 30 studies in Dermatitis, Atopic by Eli Lilly and Company, this one is the 16th largest by enrollment, is one of 7 that started in 2018, is one of 5 in phase 2, and was the 8th registered.
Eli Lilly and Company’s Dermatitis, Atopic studies by the year they started, since 2013.
3 of the studies testing lebrikizumab in Dermatitis, Atopic that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06526182Phase 3Almirall, S.A.A Study of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis | 2027-04-25 |
| NCT06906497Johann E Gudjonsson MD PhDLebrikizumab in Moderate-to-severe Atopic Dermatitis | 2027-07 |
| NCT07856134Forefront Dermatology S.CAD Treatment Optimization With Ebglyss in Real-World Practice: A Multicenter Study of Patient-Centered Outcomes | 2027-08-31 |
Add all 3 to your calendar (.ics) → With an account.
Among the 24 studies testing lebrikizumab in Dermatitis, Atopic, from their registry updates:
Among Eli Lilly and Company’s 30 in Dermatitis, Atopic:
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The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in participants with moderate-to-severe atopic dermatitis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Lebrikizumab · Drug: Placebo
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.
Biological: Lebrikizumab · Drug: Placebo
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).
Biological: Lebrikizumab · Drug: Placebo
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.
Drug: Placebo
Sterile liquid solution administered subcutaneously.
Also known as: LY3650150, DRM06
Solution administered subcutaneously.
Percent Change From Baseline in Eczema Area and Severity Index (EASI)
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.
Time frame: Baseline, Week 16
Percentage of Participants With a 75% Improvement From Baseline in EASI (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 EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.
Time frame: Week 16
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Reduction ≥2 Points From Baseline to Week 16 (5-point Scale)
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.
Time frame: Week 16
Percentage of Participants With EASI <7 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).
Time frame: Week 16
Percentage of Participants Achieving EASI50 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 EASI responder is defined as a participant who achieves a ≥ 50% improvement from baseline in the EASI score.
Time frame: Week 16
Percentage of Participants Achieving EASI90 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 EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score
Time frame: Week 16
Percent Change From Baseline in the Sleep Loss Scale Score
The Sleep Loss Scale is used by the participants to report the impact of itching on their sleep every night. Participants responded to the question to what extent did your itching interfere with your sleep last night. The scale ranged from 0 to 4, with 0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments were recorded daily by the participant using an electronic diary. Least Squares (LS) Means were calculated using ANCOVA with the factor of treatment and the baseline sleep-loss scale as covariates.
Time frame: Baseline, Week 16
Percent Change From Baseline in Pruritus Numeric Rating Score (NRS)
The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Pruritus assessments were recorded daily by the participant using an electronic diary. LS Means were calculated using ANCOVA with the factor of treatments and the baseline pruritus NRS as covariates.
Time frame: Baseline, Week 16
Percentage of Participants With Pruritus NRS Change of ≥3 at Week 16
The Pruritus NRS is an 11-point scale used by participants to assess 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. The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 3-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.
Time frame: Week 16
Percentage of Participants With Pruritus NRS Change of ≥4 From Baseline to Week 16
The Pruritus NRS is an 11-point scale used by participants to assess 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. The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 4-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.
Time frame: Week 16
Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD)
The body surface area (BSA) affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region \* % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.
Time frame: Baseline, Week 16
Change From Baseline in Atopic Dermatitis Impact Questionnaire (ADIQ) Score
The ADIQ is a 17-item questionnaire used to assess the participant's AD-specific health-related quality of life. Each item is rated on a 5-point scale from 0 to 4, with higher numbers indicating greater burden. The questionnaire assesses AD's impact on emotions, energy, activities of daily living, and social activities. The ADIQ has a recall specification of 7 days. Assessments were recorded by the participant using an electronic diary and transferred to the clinical database.The ADIQ score is calculated by summing the score of each of the 14 questions resulting in a maximum of 56 and a minimum of 0, with higher scores indicating greater burden.
Time frame: Baseline, Week 16
| Milestone | 125 Milligrams (mg) Lebrikizumab - Every 4 Weeks (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab - Every 2 Weeks (Q2W) | Placebo |
|---|---|---|---|---|
| Started | 73 | 80 | 75 | 52 |
| Received at least one dose of study drug | 73 | 80 | 75 | 52 |
| Completed | 52 | 49 | 56 | 20 |
| Not completed | 21 | 31 | 19 | 32 |
| Withdrew: Adverse event | 2 | 4 | 3 | 1 |
| Withdrew: Lost to follow-up | 9 | 9 | 7 | 5 |
| Withdrew: Withdrawal by subject | 8 | 15 | 9 | 23 |
| Withdrew: Physician decision | 1 | 2 | 0 | 1 |
| Withdrew: Sponsor decision | 1 | 1 | 0 | 0 |
| Withdrew: Protocol deviation | 0 | 0 | 0 | 2 |
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.
| percent change | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo |
|---|---|---|---|---|
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) | -62.34 ± 37.266 | -69.21 ± 38.282 | -72.09 ± 37.229 | -41.12 ± 59.496 |
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.
| percentage of participants | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo |
|---|---|---|---|---|
| Percentage of Participants With a 75% Improvement From Baseline in EASI (EASI75) at Week 16 | 43.3 | 56.1 | 60.6 | 24.3 |
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.
| percentage of participants | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo |
|---|---|---|---|---|
| Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Reduction ≥2 Points From Baseline to Week 16 (5-point Scale) | 26.6 | 33.7 | 44.6 | 15.3 |
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 | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo |
|---|---|---|---|---|
| Percentage of Participants With EASI <7 at Week 16 | 42.2 | 61.2 | 61.8 | 29.3 |
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 50% improvement from baseline in the EASI score.
| percentage of participants | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo |
|---|---|---|---|---|
| Percentage of Participants Achieving EASI50 at Week 16 | 66.4 | 77.0 | 81.0 | 45.8 |
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score
| percentage of participants | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo |
|---|---|---|---|---|
| Percentage of Participants Achieving EASI90 at Week 16 | 26.1 | 36.1 | 44.0 | 11.4 |
The Sleep Loss Scale is used by the participants to report the impact of itching on their sleep every night. Participants responded to the question to what extent did your itching interfere with your sleep last night. The scale ranged from 0 to 4, with 0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments were recorded daily by the participant using an electronic diary. Least Squares (LS) Means were calculated using ANCOVA with the factor of treatment and the baseline sleep-loss scale as covariates.
| percent change | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo |
|---|---|---|---|---|
| Percent Change From Baseline in the Sleep Loss Scale Score | -48.68 ± 50.692 | -53.03 ± 50.662 | -64.69 ± 50.692 | -20.24 ± 51.066 |
The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Pruritus assessments were recorded daily by the participant using an electronic diary. LS Means were calculated using ANCOVA with the factor of treatments and the baseline pruritus NRS as covariates.
| percent change | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo |
|---|---|---|---|---|
| Percent Change From Baseline in Pruritus Numeric Rating Score (NRS) | -35.94 ± 55.553 | -49.60 ± 55.555 | -60.63 ± 55.564 | 4.26 ± 55.610 |
The Pruritus NRS is an 11-point scale used by participants to assess 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. The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 3-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.
| percentage of participants | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo |
|---|---|---|---|---|
| Percentage of Participants With Pruritus NRS Change of ≥3 at Week 16 | 50.9 | 64.9 | 76.0 | 45.5 |
The Pruritus NRS is an 11-point scale used by participants to assess 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. The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 4-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.
| percentage of participants | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo |
|---|---|---|---|---|
| Percentage of Participants With Pruritus NRS Change of ≥4 From Baseline to Week 16 | 41.8 | 47.4 | 70.0 | 27.3 |
The body surface area (BSA) affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region \* % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.
| percentage of BSA | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo |
|---|---|---|---|---|
| Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD) | -19.6 ± 19.08 | -24.9 ± 20.08 | -24.3 ± 21.00 | -17.4 ± 20.56 |
The ADIQ is a 17-item questionnaire used to assess the participant's AD-specific health-related quality of life. Each item is rated on a 5-point scale from 0 to 4, with higher numbers indicating greater burden. The questionnaire assesses AD's impact on emotions, energy, activities of daily living, and social activities. The ADIQ has a recall specification of 7 days. Assessments were recorded by the participant using an electronic diary and transferred to the clinical database.The ADIQ score is calculated by summing the score of each of the 14 questions resulting in a maximum of 56 and a minimum of 0, with higher scores indicating greater burden.
| score on a scale | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo |
|---|---|---|---|---|
| Change From Baseline in Atopic Dermatitis Impact Questionnaire (ADIQ) Score | -14.2 ± 12.74 | -18.8 ± 12.03 | -18.6 ± 12.63 | -11.0 ± 13.96 |
Collected over Baseline up to 271 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 125 mg Lebrikizumab (Q4W) | 0/73 (0%) | 2/73 (2.7%) | 41/73 (56.2%) |
| 250 mg Lebrikizumab (Q4W) | 0/80 (0%) | 0/80 (0%) | 39/80 (48.8%) |
| 250 mg Lebrikizumab (Q2W) | 0/75 (0%) | 2/75 (2.7%) | 45/75 (60%) |
| Placebo | 0/52 (0%) | 2/52 (3.8%) | 24/52 (46.2%) |
| Event | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo |
|---|---|---|---|---|
| Oedema peripheralGeneral disorders | 0/73 | 0/80 | 0/75 | 1/52 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/73 | 0/80 | 0/75 | 1/52 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/73 | 0/80 | 0/75 | 1/52 |
| Hernial eventrationGastrointestinal disorders | 1/73 | 0/80 | 0/75 | 0/52 |
| Periprosthetic fractureInjury, poisoning and procedural complications | 1/73 | 0/80 | 0/75 | 0/52 |
| Chest painGeneral disorders | 0/73 | 0/80 | 1/75 | 0/52 |
| Panic attackPsychiatric disorders | 0/73 | 0/80 | 1/75 | 0/52 |
| Event | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 4/73 | 2/80 | 9/75 | 2/52 |
| Upper respiratory tract infectionInfections and infestations | 6/73 | 9/80 | 2/75 | 3/52 |
| HeadacheNervous system disorders | 3/73 | 1/80 | 4/75 | 3/52 |
| Dermatitis atopicSkin and subcutaneous tissue disorders | 2/73 | 2/80 | 0/75 | 3/52 |
| Injection site painGeneral disorders | 0/73 | 3/80 | 4/75 | 1/52 |
| FatigueGeneral disorders | 0/73 | 4/80 | 0/75 | 0/52 |
| Bacterial vaginosisInfections and infestations | 2/46 | 0/47 | 0/49 | 0/24 |
| Vulvovaginitis gonococcalInfections and infestations | 0/46 | 0/47 | 0/49 | 1/24 |
| Vomiting in pregnancyPregnancy, puerperium and perinatal conditions | 0/46 | 0/47 | 0/49 | 1/24 |
| Back painMusculoskeletal and connective tissue disorders | 3/73 | 0/80 | 1/75 | 0/52 |
All randomized participants.
| Age, Continuous(years) | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 36.7 ± 16.54 | 40.2 ± 17.88 | 38.9 ± 17.36 | 42.2 ± 18.21 | 39.3 ± 17.48 |
| Sex: Female, Male(Participants) | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo | Total |
|---|---|---|---|---|---|
| Female | 46 | 47 | 49 | 24 | 166 |
| Male | 27 | 33 | 26 | 28 | 114 |
| Ethnicity (NIH/OMB)(Participants) | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 14 | 11 | 12 | 5 | 42 |
| Not Hispanic or Latino | 59 | 69 | 63 | 47 | 238 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 1 | 0 | 3 |
| Asian | 8 | 7 | 6 | 6 | 27 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 26 | 28 | 23 | 16 | 93 |
| White | 37 | 42 | 40 | 26 | 145 |
| More than one race | 1 | 2 | 5 | 4 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo | Total |
|---|---|---|---|---|---|
| United States | 73 | 80 | 75 | 52 | 280 |
| Eczema Area and Severity Index (EASI)(units on a scale) | 125 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q4W) | 250 mg Lebrikizumab (Q2W) | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 29.85 ± 13.517 | 26.15 ± 10.135 | 25.48 ± 11.206 | 28.90 ± 11.790 | 27.45 ± 11.764 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Ran from Jan 2018 to primary completion in Feb 2019, 12 months.
Results were first posted in May 2021, 2 years 2 months after primary completion. A results delay was requested in Mar 2020.
Of 195 industry-sponsored phase 2 interventional studies under Dermatitis, Atopic, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 17. This study's 12 months is close to that.
Counting every sponsor, half of 223 studies reached it within 14 months; a quarter within 10 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lebrikizumab