Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Efficacy and Safety of Lebrikizumab in Moderate to Severe Atopic Dermatitis (ADvocate2)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04178967
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.

Brief Summary:
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: Lebrikizumab Other: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, parallel group, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis.
Actual Study Start Date : November 8, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Placebo Comparator: Placebo

Induction Period (Baseline-Week 16):

Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.

Maintenance Period (Week 16-Week 52):

Treatment from Week 16 to Week 52 is based on re-randomization of responders in the Induction Period. Participants re-randomized to Placebo arm receive one Placebo injection Q2W.

Other: Placebo
Subcutaneous Injection

Experimental: Lebrikizumab Q2W

Induction Period (Baseline-Week 16):

Two subcutaneous (SC) injections of lebrikizumab as a loading dose at Baseline and Week 2 visits followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.

Maintenance Period (Week 16-Week 52):

Treatment from Week 16 to Week 52 is based on re-randomization of responders in the Induction Period. Participants re-randomized to Lebrikizumab Q2W arm receive lebrikizumab injection Q2W.

Biological: Lebrikizumab
Subcutaneous injection
Other Names:
  • lebri
  • DRM06

Experimental: Lebrikizumab Q4W

Maintenance Period (Week 16-Week 52):

Treatment from Week 16 to Week 52 is based on re-randomization of responders in the Induction Period. Participants re-randomized to Lebrikizumab Q4W arm receive one lebrikizumab injection Q4W.

Biological: Lebrikizumab
Subcutaneous injection
Other Names:
  • lebri
  • DRM06

Other: Placebo
Subcutaneous Injection

Experimental: Escape Arm (Lebrikizumab Q2W)

Maintenance Period (Week 16-Week 52):

Participants who require rescue treatment for atopic dermatitis during the Induction Period, or are non-responders at Week 16, will be eligible for treatment in an Escape Arm where participants will receive open-label lebrikizumab Q2W from Week 16 through Week 52. In addition, participants who do not maintain an acceptable response during the Maintenance Period (have an EASI score <50% of baseline), will be eligible for the Escape Arm.

Biological: Lebrikizumab
Subcutaneous injection
Other Names:
  • lebri
  • DRM06




Primary Outcome Measures :
  1. Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]

Secondary Outcome Measures :
  1. Percentage of patients achieving EASI-75 (≥75% reduction in EASI score) from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  2. Percentage of patients achieving EASI-90 (≥90% reduction in EASI score) from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  3. Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  4. Percentage of patients with a Pruritus NRS score of ≥4-points at Baseline who achieve a ≥4-point reduction in Pruritus NRS score from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  5. Percentage of patients with a Pruritus NRS score of ≥5-points at Baseline who achieve a ≥4-point reduction in Pruritus NRS score from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  6. Percentage change in EASI score from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  7. Change from Baseline to Week 16 in percent BSA [ Time Frame: Baseline to Week 16 ]
  8. Percentage of patients achieving EASI-90 from Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
  9. Percentage change in Sleep-loss score from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  10. Change from Baseline in Sleep-loss score at Week 16 [ Time Frame: Baseline to Week 16 ]
  11. Percentage of patients with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 1 [ Time Frame: Baseline to Week 1 ]
  12. Percentage of patients with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 2 [ Time Frame: Baseline to Week 2 ]
  13. Percentage of patients with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
  14. Percentage of patients with a Pruritus NRS score of ≥5 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 1 [ Time Frame: Baseline to Week 1 ]
  15. Percentage of patients with a Pruritus NRS score of ≥5 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 2 [ Time Frame: Baseline to Week 2 ]
  16. Percentage of patients with a Pruritus NRS score of ≥5 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female adults and adolescents (≥12 years and ≥40 kg).
  2. Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit
  3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit
  4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit.
  5. ≥10% body surface area (BSA) of atopic dermatitis involvement at the baseline visit
  6. History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.

Exclusion Criteria:

  1. Prior treatment with dupilumab or tralokinumab.
  2. Treatment with the following prior to the baseline visit:

    1. An investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer.
    2. Cell-depleting biologics, including to rituximab, within 6 months of baseline.
    3. Other biologics within 5 half-lives (if known) or 16 weeks of baseline, whichever is longer.
  3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
  4. Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma.
  5. Evidence of active acute or chronic hepatitis
  6. History of human immunodeficiency virus (HIV) infection or positive HIV serology.
  7. History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
  8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

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): NCT04178967


Contacts
Layout table for location contacts
Contact: Dermira 650-885-3349 clinicaltrials@dermira.com

Locations
Show Show 97 study locations
Sponsors and Collaborators
Dermira, Inc.
Investigators
Layout table for investigator information
Study Director: Kate Doherty Dermira, Inc.

Additional Information:
Layout table for additonal information
Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT04178967    
Other Study ID Numbers: DRM06-AD05
2019-002933-12 ( EudraCT Number )
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dermira, Inc.:
Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
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