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Monoclonal Antibodies
AK002 for Atopic Dermatitis (ATLAS Trial)
Phase 2
Waitlist Available
Research Sponsored by Allakos, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female aged ≥18 and ≤80 years at the time of signing the informed consent form.
The subject should have applied a stable dose of non-medicated, non-prescription, topical emollient at least twice daily for 7 consecutive days immediately before the baseline visit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 14
Awards & highlights
ATLAS Trial Summary
This trial is testing a new drug to see if it's effective and safe for people with moderate-to-severe eczema that isn't controlled by other treatments.
Who is the study for?
Adults aged 18-80 with moderate-to-severe Atopic Dermatitis (AD) not well-controlled by topical treatments can join. They must have used a non-medicated emollient twice daily for a week before the study, have an EASI score ≥16, IGA score ≥3, and at least 10% body surface area affected. Those who haven't responded to or can't use certain topical meds due to side effects are eligible. People currently on biologics or those without primary response to biologic treatment for AD are excluded.Check my eligibility
What is being tested?
The trial is testing Lirentelimab (AK002), administered subcutaneously every two weeks for seven doses against a placebo in adults with AD inadequately controlled by topical treatments. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real drug versus placebo during the test phase.See study design
What are the potential side effects?
While specific side effects of Lirentelimab aren't listed here, similar medications may cause reactions at injection sites, increased risk of infections, potential allergic responses, headaches, nausea and fatigue among others.
ATLAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
Select...
I have used a regular skin moisturizer twice daily for the last week.
ATLAS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The proportion of subjects who achieve 75% improvement on the Eczema Area and Severity Index (EASI-75) at Week 14
Secondary outcome measures
Percent change in EASI from baseline to Week 14
Proportion of subjects achieving an IGA score of 0 or 1 and a 2-point improvement at Week 14 vs baseline
Side effects data
From 2023 Phase 3 trial • 94 Patients • NCT0485689120%
Infusion related reaction
11%
Corona virus infection
9%
Sinusitis
7%
Abdominal pain
4%
Hiatus hernia
2%
Diabetic ketoacidosis
2%
Diarrhea
2%
Depression
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
3.0 mg/kg of Lirentelimab (AK002)
Placebo
ATLAS Trial Design
2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Placebo
Group II: Lirentelimab (AK002) SC 300 mgExperimental Treatment1 Intervention
Subjects in this arm will receive 7 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AK002
2016
Completed Phase 3
~340
Find a Location
Who is running the clinical trial?
Allakos, Inc.Lead Sponsor
14 Previous Clinical Trials
1,127 Total Patients Enrolled
Allakos Inc.Lead Sponsor
16 Previous Clinical Trials
1,402 Total Patients Enrolled
Chin Lee, MD, MPHStudy DirectorAllakos Inc.
1 Previous Clinical Trials
127 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had chemotherapy or radiotherapy in the last 6 months.I understand the study details and have signed the consent form.I have skin conditions that could affect the study's outcome.I have either never used biologic drugs or have used them but stopped due to side effects, ineffectiveness, or cost issues.I have had cancer before, but it was either in my cervix, early-stage prostate cancer, or a non-melanoma skin cancer.I haven't used any skin creams for eczema in the last week.My skin condition didn't improve after using creams like steroids for 4 weeks.I haven't taken any cell-depleting drugs or other biologics recently.I did not improve after 3 months of treatment with a biologic for AD.I haven't used specific skin or immune system treatments in the last 4 weeks.I have had chronic atopic dermatitis for at least 3 years.I am currently using biologic medication.I am between 18 and 80 years old.I have used a regular skin moisturizer twice daily for the last week.I'm sorry, I cannot provide a summary for the criterion "Key" as it is incomplete and lacks context. Could you please provide more information or clarify your question?
Research Study Groups:
This trial has the following groups:- Group 1: Lirentelimab (AK002) SC 300 mg
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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