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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~week 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 14 for reporting.

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 • NCT04856891
20%
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
1,394 Total Patients Enrolled
Chin Lee, MD, MPHStudy DirectorAllakos Inc.
1 Previous Clinical Trials
127 Total Patients Enrolled

Media Library

Lirentelimab (AK002) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05155085 — Phase 2
Atopic Dermatitis Research Study Groups: Lirentelimab (AK002) SC 300 mg, Placebo
Atopic Dermatitis Clinical Trial 2023: Lirentelimab (AK002) Highlights & Side Effects. Trial Name: NCT05155085 — Phase 2
Lirentelimab (AK002) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05155085 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study open to individuals aged 40 and over?

"As per the terms of enrolment, participants must not be younger than 18 years old or older than 80."

Answered by AI

Who qualifies to partake in this medical experiment?

"This medical research is looking for 130 participants aged 18-80 with a chronic history of dermatitis. To be eligible, subjects must have unsuccessfully attempted to treat the condition using topical corticosteroids, calcineurin inhibitors, JAK inhibitors or PDE4 inhibitors prior to screening; not had any biologic treatments within 6 months before the trial's start date; achieved an EASI score and IGA rating of 16/3 respectively at both screening and baseline visits; consented in writing after understanding all relevant study information; affected 10%+ BSA during assessment periods; used non-prescription emollient twice daily 7"

Answered by AI

What potential perils might be associated with AK002 treatment?

"There is evidence of safety around AK002, so it was given a score of 2 on our 3-point scale. This evaluation accounts for the fact that there has been no clinical data regarding its efficacy as this medical trial is currently in phase 2."

Answered by AI

In how many distinct locations is this trial currently taking place?

"This trial is being facilitated at 86 sites, including the Allakos Investigational Site in Boston, New England Research in Murray, and Clinical Research of Brandon in Portland."

Answered by AI

How many participants are taking part in this research initiative?

"Affirmative, the data from clinicaltrials.gov demonstrates active recruitment for this trial that was initially posted on June 27th 2022 and lastly updated November 21st 2022. 130 individuals are required to partake in the experiment across 86 different sites."

Answered by AI

What other experiments have been conducted involving AK002?

"AK002 was initially trialled at Allakos Investigational Site in 2020, with a cumulative number of 18327 finished studies. As of now, 3 active clinical trials are underway, many occurring within the confines of Boston Massachusetts."

Answered by AI

Has this clinical trial been undertaken previously and, if not, what makes it novel?

"The exploration of AK002 began in 2020, with the first trial funded by Allakos Inc. After that original study involving 170 people was concluded, Phase 3 drug approval followed suit. Nowadays, there are three active studies being conducted across a hundred and four locations spread out over one nation."

Answered by AI

Are researchers currently seeking participants for this research experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial began recruiting on June 27th 2022 and is still ongoing as of November 21st 2022. A total of 130 individuals are required for the study across 86 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
Other
Pennsylvania
New York
How old are they?
18 - 65
What site did they apply to?
Brock Clinical
Skin Specialists
Allakos Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis
2022. "A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05155085.
All > Seborrheic Dermatitis > Atopic Dermatitis
~47 spots leftby Apr 2025
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