A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis

Lilly

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Biological: Lebrikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03443024

17826

DRM06-AD01 (Other Identifier)

J2T-DM-KGAF (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in participants with moderate-to-severe atopic dermatitis.

Enrollment: 280 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 18 years or older.
• Chronic AD as defined by Hanifin and Rajka (1980) that has been present for ≥1 year before the screening visit .
• Eczema Area and Severity Index (EASI) score ≥16 at the screening and the baseline visit.
• Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and the baseline visit.
• ≥10% body surface area (BSA) of AD involvement at the screening and the baseline visit.

Exclusion criteria

• Treatment with any of the following agents within 4 weeks prior to the baseline visit:
• Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
• Phototherapy and photochemotherapy (PUVA) for AD.
• Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week prior to the baseline visit.
• Treatment with:
• An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to the baseline visit.
• Dupilumab within 3 months prior to baseline visit.
• Cell-depleting biologics, including rituximab, within 6 months prior to the baseline visit.
• Other biologics within 5 half-lives (if known) or 16 weeks prior to baseline visit (whichever is longer).
• Use of prescription moisturizers within 7 days of the baseline visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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280 participants in 4 patient groups, including a placebo group

125 milligrams (mg) Lebrikizumab - Every 4 Weeks (Q4W)

Experimental group

Description:

125 mg Lebrikizumab administered subcutaneously (SC) once Q4W. Baseline: Loading dose 250 mg Lebrikizumab SC (two injections SC 1-milliliter (mL) of 125 mg/mL Lebrikizumab and 1-mL placebo). Week 2: Four 1-mL SC injections placebo. Weeks 4, 8, 12: 125 mg SC Lebrikizumab and 1-mL SC placebo. Weeks 6, 10, 14: Two 1-mL SC placebo.

Treatment:

Drug: Placebo

Biological: Lebrikizumab

250 mg Lebrikizumab - Q4W

Experimental group

Description:

250 mg Lebrikizumab administered SC once Q4W. Baseline: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab). Week 2: Four 1-mL SC injections of placebo. Weeks 4, 8, 12: 250 mg (two 1-mL injections of 125 mg/mL Lebrikizumab). Weeks 6, 10, 14: Two 1-mL injections of placebo.

Treatment:

Drug: Placebo

Biological: Lebrikizumab

250 mg Lebrikizumab - Every 2 Weeks (Q2W)

Experimental group

Description:

250 mg Lebrikizumab administered SC once Q2W. Baseline and Week 2: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab). Week 4, 6, 8, 10, 12, 14: 250 mg (two 1-mL SC injections of 125 mg/mL Lebrikizumab).

Treatment:

Drug: Placebo

Biological: Lebrikizumab

Group 4 - Placebo

Placebo Comparator group

Description:

Placebo administered SC once Q2W. Baseline and Week 2: Four 1-mL SC injections of placebo. Week 4, 6, 8, 10, 12, 14: Two 1-mL SC injections of placebo.

Treatment:

Drug: Placebo