Lebrikizumab in Moderate-to-severe Atopic Dermatitis

Part of paid clinical trials in Folsom, California.

Sponsor
Johann E Gudjonsson MD PhD
Study ID
NCT06906497
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lebrikizumab — DRUG
    Patients will receive lebrikizumab with a 500 mg loading dose administered subcutaneously at baseline and Week 2 followed by 250 mg every 2 weeks until Week 24. At week 24, patients with ≥ Eczema Area and Severity Index (EASI) 50 will continue in the study and begin receiving lebrikizumab 250mg every 4 weeks (Q4W), while patients with \<EASI 50 will be discontinued from the study. At week 36, patients with EASI ≥50 to \<90 will remain on Q4W through W60 (do not enter withdrawal arm), while patients with sustained low disease activity (IGA 0/1 or EASI≥90 response for at least 3 months assessed at W24 and W36) will withdraw from lebrikizumab treatment

Study Details

This research is studying a drug already approved for the treatment of atopic dermatitis (AD). This research collects health-related information and blood and skin samples to understand if the study drug, lebrikizumab, leads to long-term improvement in AD skin.

Key Dates

Start date
Jul 2, 2025
Status verified
Aug 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Moderate-to-severe Atopic Dermatitis
    A total of 48 subjects with active moderate-to-severe Atopic Dermatitis (AD) will be enrolled in a 60-week study from 4 independent sites (2 US sites and 2 EU sites).

Primary Outcome Measure

Degree of normalization of transcriptomic/epigenetic profile [ Time Frame: Up to week 60 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Physioseq USA - CAFolsomCalifornia95630
Stephanie Le
[email protected]
(916) 603-2157
Emanual Maverakis, MD (SUB_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Johann E. Gudjonsson, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Folsom, CA

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Physioseq USA - CA· Folsom, CAUniversity of Michigan· Ann Arbor, MI

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