Trial · NCT04392154
Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin)
NCT04392154, Phase 3, Completed, Eli Lilly and Company; results first posted 2025-08-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin). Trials, record NCT04392154. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04392154
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin)
- NCT number
- NCT04392154
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,153 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Atopic Dermatitis
- Interventions
- Lebrikizumab
- First posted
- 2020-05-18
- Last updated
- 2025-11-05
- Other registries' IDs
- eudract:2020-001211-24
- Results first posted
- 2025-08-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Treatment Period: Percentage of Participants Discontinued From Study Treatment Due to Adverse Events | Baseline to Week 100 | Percentage of participants discontinued from study treatment due to adverse events is reported. |
| Secondary | Primary Treatment Period: Percentage of Participants With a Response of Investigator Global Assessment (IGA) Score 0 or 1 at Week 100 | Week 100 | The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis. The IGA is comprised of a 5-point numeric scale ranging from 0 (clear skin) to 4 (severe disease) and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point. |
| Secondary | Primary Treatment Period: Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) at Week 100 | Week 100 | EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs, by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. The final EASI score will be obtained by weight-averaging these 4 scores and will range from 0 to 72. A higher score represents greater disease severity. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Treatment Period: Percentage of Participants Discontinued From Study Treatment Due to Adverse Events | Baseline to Week 100 | All participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Primary Treatment Period: Percentage of Participants With a Response of Investigator Global Assessment (IGA) Score 0 or 1 at Week 100 | Week 100 | All participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Primary Treatment Period: Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) at Week 100 | Week 100 | All participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Treatment Period: Percentage of Participants Discontinued From Study Treatment Due to Adverse Events | Primary Treatment Period: Lebrikizumab Q4W | 2.1 | percentage of participants | ||
| Primary Treatment Period: Percentage of Participants Discontinued From Study Treatment Due to Adverse Events | Primary Treatment Period: Lebrikizumab Q2W | 4.5 | percentage of participants | ||
| Primary Treatment Period: Percentage of Participants With a Response of Investigator Global Assessment (IGA) Score 0 or 1 at Week 100 | Primary Treatment Period: Lebrikizumab Q4W | 80.1 | Percentage of participants | ||
| Primary Treatment Period: Percentage of Participants With a Response of Investigator Global Assessment (IGA) Score 0 or 1 at Week 100 | Primary Treatment Period: Lebrikizumab Q2W | 60.6 | Percentage of participants | ||
| Primary Treatment Period: Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) at Week 100 | Primary Treatment Period: Lebrikizumab Q4W | 90.4 | Percentage of participants | ||
| Primary Treatment Period: Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) at Week 100 | Primary Treatment Period: Lebrikizumab Q2W | 79.4 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Primary Treatment Period (100 Weeks) | STARTED | Primary Treatment Period: Lebrikizumab Q4W | 141 | |
| Primary Treatment Period (100 Weeks) | STARTED | Primary Treatment Period: Lebrikizumab Q2W | 1,012 | |
| Primary Treatment Period (100 Weeks) | STARTED | Open-Label Extension Addendum: Lebrikizumab Q4W | 0 | |
| Primary Treatment Period (100 Weeks) | STARTED | Open-Label Extension Addendum: Lebrikizumab Q8W | 0 | |
| Primary Treatment Period (100 Weeks) | Received at Least 1 Dose of Study Drug | Primary Treatment Period: Lebrikizumab Q4W | 141 | |
| Primary Treatment Period (100 Weeks) | Received at Least 1 Dose of Study Drug | Primary Treatment Period: Lebrikizumab Q2W | 1,012 | |
| Primary Treatment Period (100 Weeks) | Received at Least 1 Dose of Study Drug | Open-Label Extension Addendum: Lebrikizumab Q4W | 0 | |
| Primary Treatment Period (100 Weeks) | Received at Least 1 Dose of Study Drug | Open-Label Extension Addendum: Lebrikizumab Q8W | 0 | |
| Primary Treatment Period (100 Weeks) | COMPLETED | Primary Treatment Period: Lebrikizumab Q4W | 103 | |
| Primary Treatment Period (100 Weeks) | COMPLETED | Primary Treatment Period: Lebrikizumab Q2W | 675 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events2,432
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Primary Treatment Period: Lebrikizumab Q4W | 1 | 141 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Primary Treatment Period: Lebrikizumab Q2W | 6 | 1,012 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Open-Label Extension Addendum: Lebrikizumab Q4W | 0 | 52 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Open-Label Extension Addendum: Lebrikizumab Q8W | 0 | 51 | 0 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Primary Treatment Period: Lebrikizumab Q4W | 0 | 141 | 0 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Primary Treatment Period: Lebrikizumab Q2W | 1 | 1,012 | 1 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Open-Label Extension Addendum: Lebrikizumab Q4W | 0 | 52 | 0 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Open-Label Extension Addendum: Lebrikizumab Q8W | 0 | 51 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Primary Treatment Period: Lebrikizumab Q4W | 1 | 141 | 1 |
| other | Eosinophilia | Blood and lymphatic system disorders | Primary Treatment Period: Lebrikizumab Q2W | 10 | 1,012 | 12 |
1 to 10 of 2,432Source ClinicalTrials.gov
See all 2,432 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Primary Treatment Period: Lebrikizumab Q4W | 0 | 141 |
| Total, all-cause mortality | Primary Treatment Period: Lebrikizumab Q2W | 2 | 1,012 |
| Total, all-cause mortality | Open-Label Extension Addendum: Lebrikizumab Q4W | 0 | 52 |
| Total, all-cause mortality | Open-Label Extension Addendum: Lebrikizumab Q8W | 0 | 51 |
| Total, other adverse events | Primary Treatment Period: Lebrikizumab Q4W | 89 | 141 |
| Total, other adverse events | Primary Treatment Period: Lebrikizumab Q2W | 638 | 1,012 |
| Total, other adverse events | Open-Label Extension Addendum: Lebrikizumab Q4W | 17 | 52 |
| Total, other adverse events | Open-Label Extension Addendum: Lebrikizumab Q8W | 13 | 51 |
| Total, serious adverse events | Primary Treatment Period: Lebrikizumab Q4W | 5 | 141 |
| Total, serious adverse events | Primary Treatment Period: Lebrikizumab Q2W | 45 | 1,012 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04392154
GET https://conductscience.org/api/trials/v1/NCT04392154/flow?page=2