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A Study of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03443024
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: Lebrikizumab Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : February 7, 2019
Actual Study Completion Date : May 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Group 1
Lebrikizumab, 125 mg every 4 weeks
Biological: Lebrikizumab
Sterile liquid solution injected subcutaneously

Experimental: Group 2
Lebrikizumab, 250 mg every 4 weeks
Biological: Lebrikizumab
Sterile liquid solution injected subcutaneously

Experimental: Group 3
Lebrikizumab, 250 mg every 2 weeks
Biological: Lebrikizumab
Sterile liquid solution injected subcutaneously

Placebo Comparator: Group 4
Placebos, every 2 weeks
Drug: Placebos
Solution injected subcutaneously




Primary Outcome Measures :
  1. Percent change in Eczema Area and Severity Index (EASI) from baseline to Week 16. [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Proportion of patients with a 75% improvement from baseline in EASI (EASI75) at Week 16. [ Time Frame: Week 16 ]
  2. Proportion of patient with an IGA score of 0 (clear) or 1 (almost clear) and a reduction ≥2 points from baseline to Week 16 (5-point scale). [ Time Frame: Week 16 ]
  3. Proportion of patients with EASI <7 at Week 16. [ Time Frame: Week 16 ]
  4. Proportion of patients achieving EASI50 and EASI90 at Week 16. [ Time Frame: Week 16 ]
  5. Percent change in the sleep loss numerical rating scale (NRS) score from baseline to Week 16. [ Time Frame: Week 16 ]
  6. Percent change in pruritus NRS score from baseline to Week 16. [ Time Frame: Week 16 ]
  7. Proportion of patients with pruritus NRS change of ≥3 from baseline to Week 16. [ Time Frame: Week 16 ]
  8. Proportion of patients with pruritus NRS change of ≥4 from baseline to Week 16. [ Time Frame: Week 16 ]
  9. Change in Body Surface Area (BSA) involved with AD from baseline to Week 16. [ Time Frame: Week 15 ]
  10. Change from Baseline in Atopic Dermatitis Impact Questionnaire (ADIQ) score. [ Time Frame: Week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443024


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Sponsors and Collaborators
Dermira, Inc.

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Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT03443024     History of Changes
Other Study ID Numbers: DRM06-AD01
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dermira, Inc.:
Eczema

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs