Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT04392154) looked at a medicine called lebrikizumab in people with atopic dermatitis (eczema). During the main part of the trial, which ran for 100 weeks, 141 participants received the medicine once every four weeks (Q4W) and 1,012 participants received it once every two weeks (Q2W). A separate 32-week extension phase then followed for a smaller group of 103 participants, split roughly evenly between a once-every-four-weeks group and a once-every-eight-weeks group. The trial measured several things, including how many people stopped taking the medicine because of unwanted side effects, as well as two standard eczema scoring tools used by doctors to assess skin appearance and the area of skin affected. The reported data shows the following numbers from the main 100-week period. For the primary outcome — the proportion of participants who stopped the medicine due to adverse events (unwanted health effects) — 2.1% in the Q4W group and 4.5% in the Q2W group did so. For one secondary outcome, a doctor's rating scale called the IGA (scored 0 to 4, where 0 means clear skin), 80.1% of the Q4W group and 60.6% of the Q2W group were reported to have achieved a score of 0 or 1 (meaning clear or nearly clear skin) at week 100. For another secondary outcome using a different scoring tool called EASI-75 — which measures whether a participant's eczema severity score improved by at least 75% — 90.4% of the Q4W group and 79.4% of the Q2W group were reported to have reached that level of improvement at week 100. Completion rates and outcome numbers for the extension phase were not reported in the submitted data beyond participant counts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 42315763) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Eczema Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
For people coming from a related ("parent") lebrikizumab study:
- People who previously received treatment in one of the specified lebrikizumab parent studies (NCT04146363, NCT04178967, NCT04250337, or NCT04250350) and fully completed that study's treatments and final visit
- Women who are able to become pregnant and agree to either avoid heterosexual intercourse, or use a highly effective form of birth control, during treatment and for at least 18 weeks after the last dose of the study drug
For people joining the Open-Label Addendum (a separate entry pathway):
- Adults and teenagers aged 12 and older (but under 18) who weigh at least 40 kg (about 88 pounds), as well as adult participants
- People who have had eczema (atopic dermatitis) as a long-term condition, diagnosed for at least 1 year before the screening visit
- People whose eczema scores at the start of the study meet specific severity thresholds set by doctors using standard medical scales (confirm with trial site)
- People whose eczema covers at least 10% of their body surface at the start of the study
- People whose eczema has not responded well enough to prescription creams or ointments, or for whom topical treatments are not medically suitable
For people joining the Open-Label Extension Addendum:
- People who have completed Week 100 of the main study (referred to as Study KGAA) and have not yet attended their final safety follow-up visit for that study
Who may not be able to join:
For people coming from a related ("parent") lebrikizumab study:
- People who experienced a serious harmful reaction during the parent study that doctors believe was caused by lebrikizumab and could indicate that continuing treatment would carry unreasonable risk
- People who had a harmful reaction during the parent study that was linked to lebrikizumab and caused them to stop treatment, if doctors believe continuing would carry unreasonable risk
- People who met conditions during the parent study that required permanent stopping of the study drug, or who were withdrawn from the study for reasons such as not following the study rules or being unable to complete required assessments
- Women who are currently pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
For people joining the Open-Label Addendum:
- People who have previously received lebrikizumab in any clinical study
- People with a history of a severe allergic reaction (anaphylaxis)
- People who have used certain prescription skin treatments — including moisturizers, steroid creams, calcineurin inhibitors, or specific anti-inflammatory creams such as crisaborole — within 1 week before the study start
- People who have used immune-suppressing or immune-modifying medicines (such as oral steroids, cyclosporine, methotrexate, or similar drugs) within 4 weeks before the study start
- People who have received light therapy (phototherapy or PUVA) for eczema within 4 weeks before the study start
- People who have taken another experimental drug within 8 weeks before the study start, or within 5 half-lives of that drug (whichever is longer)
- People who have received certain biological medicines that reduce B cells (such as rituximab) within 6 months before the study start
- People who have received other biological medicines within 8 weeks before the study start, or within 5 half-lives of that medicine (whichever is longer)
- People who have used a tanning booth or sunbed more than twice a week in the 4 weeks before the study start
- People who have received a live or live-attenuated vaccine within 12 weeks before the study start, or who plan to receive one during the study
- People with an uncontrolled long-term condition that requires repeated use of oral steroid medicines — for example, severe uncontrolled asthma
- Women who are currently pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
- People with signs of active liver inflammation (hepatitis), whether recent or ongoing
- People with a history of HIV infection, or whose HIV test comes back positive at screening
- People who have had a cancer diagnosis within the past 5 years, with limited exceptions for certain fully treated and resolved skin cancers or cervical conditions (confirm with trial site)
For people joining the Open-Label Extension Addendum:
- People who began taking any medicine that is not permitted under the main study rules before the addendum start date — including biological medicines used for eczema such as dupilumab or tralokinumab, even if taken during the safety follow-up period
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Call 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
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
19 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Primary Treatment Period: Percentage of Participants Discontinued From Study Treatment Due to Adverse Events
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.