Monoclonal Antibodies
Lebrikizumab for Atopic Dermatitis
Axon Clinical Research, Inglewood, CA
LebrikizumabPhase 3RecruitingResearch Sponsored by Eli Lilly and CompanyEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants who are Fitzpatrick phototype IV-VI
Contraceptive use - Male and/or female
Must not have
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline, week 24
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Study Summary
This trialtests a drug to treat atopic dermatitis, a common skin condition, in teens and adults, especially in people with skin of color.
Eligible Conditions
- Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have dark skin (Fitzpatrick phototype IV-VI).
Select...
You must use birth control if you are a man or a woman.
Select...
Your skin condition has a score of 16 or higher on a scale called EASI (Eczema Area and Severity Index).
Select...
You have tried using creams or ointments before, but they didn't work well for you.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (≥75% reduction from baseline in EASI)
Secondary outcome measures
Change from Baseline in Children's Dermatology Life Quality Index (cDLQI)
Change from Baseline in DLQI
Change from Baseline in Dermatology Life Quality Index (DLQI)
+17 moreSide effects data
From 2022 Phase 3 trial • 424 Patients • NCT0414636313%
Covid-19
10%
Nasopharyngitis
6%
Dermatitis atopic
5%
Conjunctivitis allergic
4%
Benign prostatic hyperplasia
3%
Vulvovaginal candidiasis
3%
Oral herpes
3%
Sinusitis
3%
Contusion
3%
Aspartate aminotransferase increased
3%
Headache
2%
Cholecystitis
2%
Impetigo
2%
Hepatic steatosis
2%
Food allergy
2%
Postoperative wound infection
2%
Overdose
2%
Myalgia
2%
Cough
2%
Solar lentigo
2%
Somatic symptom disorder
2%
Eyelid oedema
2%
Sunburn
2%
Otitis media
2%
Upper respiratory tract infection
2%
Vaccination complication
2%
Blood lactate dehydrogenase increased
2%
Osteoarthritis
2%
Alopecia
2%
Pruritus
2%
Urticaria
2%
Eyelid irritation
2%
Conjunctivitis
2%
Herpes dermatitis
2%
Tooth infection
2%
Urinary tract infection
2%
Ligament sprain
2%
Alanine aminotransferase increased
2%
Weight increased
2%
Back pain
2%
Sciatica
2%
Micturition disorder
2%
Erythema
2%
Papule
2%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Blinded - Placebo Responder/ Lebrikizumab Q2W
Maintenance Blinded - Lebrikizumab Responder/Lebrikizumab Q4W
Maintenance Blinded - Lebrikizumab Responder/Lebrikizumab Q2W
Escape Arm Week 16 - Maintenance OL- Lebrikizumab Non-Responder/Lebrikizumab Q2W
Escape Arm Week 24 to 48 - Maintenance Lebrikizumab
Maintenance Blinded - Placebo Responder/Lebrikizumab Q4W
Maintenance Blinded - Placebo Responder/ Placebo
Escape Arm Week 16 - Maintenance Open Label (OL) -Placebo Non-Responder/Lebrikizumab Q2W
Induction - Placebo
Maintenance Blinded - Lebrikizumab Responder/ Placebo
Induction - Lebrikizumab 250mg Q2W
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: LebrikizumabExperimental Treatment1 Intervention
Participants will receive Lebrikizumab subcutaneously (SC).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lebrikizumab
2014
Completed Phase 3
~6750
Find a site
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,531 Previous Clinical Trials
3,173,759 Total Patients Enrolled
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)Study Director
Eli Lilly and Company1,300 Previous Clinical Trials
394,508 Total Patients Enrolled
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559Study Director
Eli Lilly and CompanyMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree does Lebrikizumab present a risk to individuals?
"The safety of Lebrikizumab is rated a 3, indicating that there has been preceding evidence to demonstrate its efficacy and multiple evaluations in favor of the drug's security."
Answered by AI
Does this research endeavor currently accept new enrollees?
"Investigation of clinicaltrials.gov reveals that this medical trial is not enrolling patients at the current moment, having been posted on December 15th 2022 and last updated on December 7th 2022. Fortunately, there are an additional 237 studies currently recruiting participants."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
San Francisco Research Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria