A Phase 3 interventional study of Lebrikizumab in Atopic Dermatitis, sponsored by Eli Lilly and Company. Completed at 70 sites in 4 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-02-24.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
This is an open-label, single arm study of 52 weeks duration. The study will assess the safety and efficacy of lebrikizumab in adolescent participants (≥12 to \<18 years weighing ≥40 kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 206 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with the following prior to the baseline visit:
Participants received two subcutaneous (SC) injections of 250 milligram(mg) Lebrikizumab at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 up to (but not including) Week 52.
Biological: Lebrikizumab
Subcutaneous injection
Also known as: LY3650150, DRM06
Percentage of Participants Discontinued From Study Treatment Due to Adverse Events (AEs)
The percentage of participants who discontinued from study treatment due to 1 or more AEs assessed is summarized cumulatively. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Week 52
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Time frame: Week 52
Percentage of Participants Achieving ≥75% Reduction From Baseline in Eczema Area and Severity Instrument (EASI) Score (EASI-75)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.
Time frame: Week 52
Percentage Change From Baseline in EASI Score
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).
Time frame: Baseline, Week 52
Percentage of Participants Achieving EASI-50 (≥50 Reduction From Baseline in EASI Score)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 50% improvement from baseline in the EASI score.
Time frame: Week 52
Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score)
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score.
Time frame: Week 52
Change From Baseline in Body Surface Area (BSA)
The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region \* % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.
Time frame: Baseline, Week 52
Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Anxiety
PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety.
Time frame: Baseline, Week 52
Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Depression
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion Distress-Depression. Questions are measured on a 5-point scale with 1 being "Never" and 5 being "Always". Responses for each section will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service, which rescales the raw score to a standardized T-Score with a population mean of 50 and a standard deviation of 10. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms.
Time frame: Baseline, Week 52
Change From Baseline in Dermatology Life Quality Index (DLQI)
The DLQI questionnaire designed for participants aged 17 years or more is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.
Time frame: Baseline, Week 52
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)
The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms \& feelings, leisure, school or holidays, personal relationships, sleep, \& treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment).
Time frame: Baseline, Week 52
Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab
Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab was evaluated at Week 52.
Time frame: Predose: Week 52
| Milestone | Lebrikizumab 250 mg |
|---|---|
| Started | 206 |
| Completed | 172 |
| Not completed | 34 |
| Withdrew: Withdrawal by subject | 13 |
| Withdrew: Lost to follow-up | 8 |
| Withdrew: Adverse event | 5 |
| Withdrew: Lack of efficacy | 4 |
| Withdrew: Physician decision | 1 |
| Withdrew: Participant moved out of the country/non-compliance | 3 |
The percentage of participants who discontinued from study treatment due to 1 or more AEs assessed is summarized cumulatively. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
| percentage of participants | Lebrikizumab 250 mg |
|---|---|
| Percentage of Participants Discontinued From Study Treatment Due to Adverse Events (AEs) | 2.4 |
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 | Lebrikizumab 250 mg |
|---|---|
| Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline | 62.6 (55.6 to 69.6) |
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 | Lebrikizumab 250 mg |
|---|---|
| Percentage of Participants Achieving ≥75% Reduction From Baseline in Eczema Area and Severity Instrument (EASI) Score (EASI-75) | 81.9 (76.5 to 87.4) |
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 | Lebrikizumab 250 mg |
|---|---|
| Percentage Change From Baseline in EASI Score | -86.0 (-89.1 to -83.0) |
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 | Lebrikizumab 250 mg |
|---|---|
| Percentage of Participants Achieving EASI-50 (≥50 Reduction From Baseline in EASI Score) | 94.4 (91.1 to 97.7) |
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 | Lebrikizumab 250 mg |
|---|---|
| Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) | 61.4 (54.5 to 68.3) |
The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region \* % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.
| percentage of body surface area | Lebrikizumab 250 mg |
|---|---|
| Change From Baseline in Body Surface Area (BSA) | -37.63 ± 21.071 |
PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety.
| T-score | Lebrikizumab 250 mg |
|---|---|
| Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Anxiety | -6.34 ± 9.979 |
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion Distress-Depression. Questions are measured on a 5-point scale with 1 being "Never" and 5 being "Always". Responses for each section will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service, which rescales the raw score to a standardized T-Score with a population mean of 50 and a standard deviation of 10. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms.
| T-score | Lebrikizumab 250 mg |
|---|---|
| Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Depression | -3.43 ± 9.057 |
The DLQI questionnaire designed for participants aged 17 years or more is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.
| score on a scale | Lebrikizumab 250 mg |
|---|---|
| Change From Baseline in Dermatology Life Quality Index (DLQI) | -8.92 (-10.8 to -7.1) |
The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms \& feelings, leisure, school or holidays, personal relationships, sleep, \& treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment).
| score on a scale | Lebrikizumab 250 mg |
|---|---|
| Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) | -6.45 (-7.4 to -5.5) |
Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab was evaluated at Week 52.
| microgram per milliliter (μg/mL) | Lebrikizumab 250 mg |
|---|---|
| Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab | 82.3 ± 39.8 |
Collected over Baseline up to Week 52. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lebrikizumab 250mg | 1/206 (0.5%) | 5/206 (2.4%) | 133/206 (64.6%) |
| Event | Lebrikizumab 250mg |
|---|---|
| Testicular torsionReproductive system and breast disorders | 1/98 |
| Cardiac arrestCardiac disorders | 1/206 |
| Bile duct stoneHepatobiliary disorders | 1/206 |
| Multiple injuriesInjury, poisoning and procedural complications | 1/206 |
| Dermatitis atopicSkin and subcutaneous tissue disorders | 1/206 |
| Event | Lebrikizumab 250mg |
|---|---|
| Dermatitis atopicSkin and subcutaneous tissue disorders | 26/206 |
| NasopharyngitisInfections and infestations | 20/206 |
| Covid-19Infections and infestations | 19/206 |
| Upper respiratory tract infectionInfections and infestations | 13/206 |
| HeadacheNervous system disorders | 12/206 |
| Oral herpesInfections and infestations | 11/206 |
| ConjunctivitisInfections and infestations | 10/206 |
| EosinophiliaBlood and lymphatic system disorders | 8/206 |
| CoughRespiratory, thoracic and mediastinal disorders | 7/206 |
| AcneSkin and subcutaneous tissue disorders | 7/206 |
All enrolled or randomized participants who received at least one dose of study drug.
| Age, Categorical(Participants) | Lebrikizumab 250 mg |
|---|---|
| <=18 years | 206 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Lebrikizumab 250 mg |
|---|---|
| Mean | 14.6 ± 1.79 |
| Sex: Female, Male(Participants) | Lebrikizumab 250 mg |
|---|---|
| Female | 108 |
| Male | 98 |
| Race (NIH/OMB)(Participants) | Lebrikizumab 250 mg |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 24 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 26 |
| White | 138 |
| More than one race | 11 |
| Unknown or Not Reported | 5 |
| Region of Enrollment(Participants) | Lebrikizumab 250 mg |
|---|---|
| Canada | 20 |
| United States | 111 |
| Poland | 63 |
| Australia | 12 |
| Weight(Participants) | Lebrikizumab 250 mg |
|---|---|
| <60 kg | 92 |
| >=60 - <100 kg | 95 |
| >= 100 kg | 19 |
Documents are hosted by the registry — open the source record to download them.
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, Sap, Csr
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