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Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants 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. 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: NCT04392154
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : September 17, 2020
Sponsor:
Collaborator:
Dermira, Inc. a wholly owned subsidiary of Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to evaluate the long-term safety and efficacy of lebrikizumab in participants with moderate-to-severe atopic dermatitis.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 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)
Primary Purpose: Treatment
Official Title: A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : May 30, 2024
Estimated Study Completion Date : May 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Lebrikizumab Q2W
Participants randomized to Lebrikizumab Q2W arm will receive investigational product on a once every 2 week schedule.
Biological: Lebrikizumab
Subcutaneous injection
Other Names:
  • LY3650150
  • DRM06

Experimental: Lebrikizumab Q4W

Participants randomized to Lebrikizumab Q4W arm will receive investigational product on a once every 4 week schedule.

Intervention assigned: Lebrikizumab balanced with Placebo to maintain the blind between treatment arms.

Biological: Lebrikizumab
Subcutaneous injection
Other Names:
  • LY3650150
  • DRM06




Primary Outcome Measures :
  1. Proportion of participants discontinued from study treatment due to adverse events through the last treatment visit. [ Time Frame: Baseline to Week 52 ]

Secondary Outcome Measures :
  1. Proportion of participants with a response of IGA 0 or 1 [ Time Frame: Baseline to Week 52 ]
  2. Proportion of participants achieving response of EASI-75 from baseline of parent study. [ Time Frame: Baseline to Week 52 ]


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.


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

Inclusion Criteria:

Participants must meet all the following criteria to be eligible for this study:

  1. Received treatment in a lebrikizumab study, NCT04146363, NCT04178967, NCT04250337, NCT04250350 and have adequately completed the study treatments and last patient visit of the parent trial.
  2. Willing and able to comply with all clinic visits and study-related procedures.
  3. For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of lebrikizumab or placebo.

    NOTE: A woman of childbearing potential (WOCBP) is defined as a postmenarcheal female, who has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause) and has not undergone surgical sterilization (removal of ovaries and/or uterus).

    NOTE: The following are highly effective contraceptive methods: combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation, progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, or sexual abstinence. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.

  4. Male participants must agree to use an effective barrier method of contraception during the study and for a minimum of 18 weeks following the last dose of study drug if sexually active with a female of child-bearing potential.
  5. Provide signed informed consent/assent.

Exclusion Criteria:

Participants meeting any of the criteria below will not be included in this study:

  1. Participants who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant. *
  2. Participants who, during their participation in the parent trial, developed an AE that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant. *
  3. Conditions in the previous parent study consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to lebrikizumab or led to investigator - or sponsor-initiated withdrawal of participant from the study (e.g., non-compliance, inability to complete study assessments, etc.). *
  4. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

Note for exclusion criteria # 1, 2, and 3: In studies that are still blinded, conditions deemed related to the study treatment will be considered related to lebrikizumab.


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): NCT04392154


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

Locations
Show Show 197 study locations
Sponsors and Collaborators
Eli Lilly and Company
Dermira, Inc. a wholly owned subsidiary of Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04392154    
Other Study ID Numbers: 17789
2020-001211-24 ( EudraCT Number )
J2T-DM-KGAA ( Other Identifier: Eli Lilly and Company )
DRM06-AD07 ( Other Identifier: Dermira, Inc. )
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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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 Eli Lilly and Company:
Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases