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Trial record 21 of 157 for:    Dermatitis, Atopic, 8

A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT02340234
Recruitment Status : Completed
First Posted : January 16, 2015
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE January 13, 2015
First Posted Date  ICMJE January 16, 2015
Last Update Posted Date October 2, 2017
Study Start Date  ICMJE May 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
Percentage of Participants Achieving a 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50) at Week 12 [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
Percentage of patients achieving a 50% reduction in Eczema Area and Severity Index (EASI) score (EASI-50) from baseline to Week 12 [ Time Frame: Week 12 ]
Change History Complete list of historical versions of study NCT02340234 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
  • Percent Change From Baseline in EASI Score at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Absolute Change From Baseline in EASI Score at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 12 [ Time Frame: Week 12 ]
  • Percentage of Participants Achieving an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 12 [ Time Frame: Week 12 ]
  • Percentage of Participants With a Greater Than or Equal to (>/=) 2 Point Reduction From Baseline in IGA at Week 12 [ Time Frame: Week 12 ]
  • Absolute Change From Baseline in IGA at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Percentage of Participants Achieving an Investigator Global Signs Assessment (IGSA) Score of 0 or 1 at Week 12 [ Time Frame: Week 12 ]
  • Percentage of Participants with a >/=2 Point Reduction From Baseline in IGSA at Week 12 [ Time Frame: Week 12 ]
  • Absolute Change From Baseline in IGSA at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Percent Change From baseline in Severity Scoring of Atopic Dermatitis (SCORAD) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Absolute Change From baseline in SCORAD at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Percentage of Participants With a 50% or 75% Reduction From Baseline in SCORAD-50/75 at Week 12 [ Time Frame: Week 12 ]
  • Percentage of Participants Achieving EASI-50 at Week 12 and Maintaining EASI-50 at Weeks 16 [ Time Frame: Weeks 12, 16 ]
  • Percentage of Participants Achieving EASI-50 at Week 12 and Maintaining EASI-50 at Weeks 16 and 20 [ Time Frame: Weeks 12, 16, 20 ]
  • Percentage of Participants Achieving IGA Score of 0 or 1 at Week 12 and Maintaining IGA Score of 0 or 1 at Weeks 16 [ Time Frame: Weeks 12, 16 ]
  • Percentage of Participants Achieving IGA Score of 0 or 1 at Week 12 and Maintaining IGA Score of 0 or 1 at Weeks 16 and 20 [ Time Frame: Weeks 12, 16, 20 ]
  • Percentage of Participants Achieving IGSA Score of 0 or 1 at Week 12 and Maintaining IGSA Score of 0 or 1 at Weeks 16 [ Time Frame: Weeks 12, 16 ]
  • Percentage of Participants Achieving IGSA Score of 0 or 1 at Week 12 and Maintaining IGSA Score of 0 or 1 at Weeks 16 and 20 [ Time Frame: Weeks 12, 16, 20 ]
  • Percentage of Participants Achieving SCORAD-50 at Week 12 and Maintaining SCORAD-50 at Weeks 16 [ Time Frame: Weeks 12, 16 ]
  • Percentage of Participants Achieving SCORAD-50 at Week 12 and Maintaining SCORAD-50 at Weeks 16 and 20 [ Time Frame: Weeks 12, 16, 20 ]
  • Percent Change From Baseline in Total % Body Surface Area (BSA) Affected At Week 12 [ Time Frame: Baseline, Week 12 ]
  • Absolute Change From Baseline in Pruritus as Measured by the Pruritus Visual Analog Scale (VAS) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Percent Change From Baseline in Pruritus as Measured by the Pruritus VAS at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Absolute Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Percent Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Total Use (Grams) of TCS From Baseline to Week 12 [ Time Frame: From Baseline to Week 12 ]
  • Total Use (Grams) of TCS From Week 12 to End of Study or Early Termination [ Time Frame: From Week 12 to end of study or early termination (up to approximately 20 weeks) ]
  • Number of Disease Flares From Baseline to Week 12 [ Time Frame: From Baseline to Week 12 ]
  • Change in AD Symptoms From Baseline to Week 12, as Assessed by the Atopic Dermatitis Symptom Diary (ADSD) [ Time Frame: Baseline, Week 12 ]
  • Change in AD-Specific HealthRelated Quality of Life (QoL) From Baseline to Week 12, as Assessed by the Atopic Dermatitis Impact Questionnaire (ADIQ) [ Time Frame: Baseline, Week 12 ]
  • Change in Health-Related QoL From Baseline to Week 12, as Measured by the Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline, Week 12 ]
  • Percentage of Participants With Treatment-Emergent Adverse Events (AEs) [ Time Frame: From start of run-in period (Day -14) until study completion (up to approximately 20 Weeks) ]
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Lebrikizumab [ Time Frame: Pre-dose on Days 1, 29, 85, 141, study discontinuation visit (up to Day 141) ]
  • Percentage of Participants With ATA to Phospholipase B-Like 2 (PLBL2) Protein [ Time Frame: Pre-dose on Days 1, 29, 85, 141, study discontinuation visit (up to Day 141) ]
  • Percentage of Participants With Disease Rebound [ Time Frame: From Week 12 up to approximately 20 weeks ]
  • Maximum Serum Concentration (Cmax) of Lebrikizumab [ Time Frame: After first dose of lebrikizumab at Week 1 ]
  • Time to Reach Cmax (Tmax) of Lebrikizumab [ Time Frame: After first dose of lebrikizumab at Week 1 ]
  • Minimum Serum Concentration (Cmin) of Lebrikizumab [ Time Frame: Pre-dose at Weeks 4, 8, 12 ]
  • Elimination Half-Life (t1/2) of Lebrikizumab [ Time Frame: Pre-dose on Days 1, 8, 29, 43, 57, 85, 113, 141, study discontinuation visit (up to Day 141) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
  • Efficacy (composite outcome measure): Percent and absolute change from baseline in EASI score at Week 12 [ Time Frame: Week 12 ]
  • Percent of patients achieving an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 12 [ Time Frame: Week 12 ]
  • Efficacy (composite outcome measure): Percent and absolute change from baseline in Severity Scoring of Atopic Dermatitis (SCORAD) at Week 12 [ Time Frame: Week 12 ]
  • Frequency and severity of treatment-emergent adverse events [ Time Frame: Up to 20 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis
Official Title  ICMJE A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lebrikizumab in Patients With Persistent Moderate to Severe Atopic Dermatitis That is Inadequately Controlled by Topical Corticosteroids
Brief Summary This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of lebrikizumab administered subcutaneously (SC) in adult participants with persistent moderate to severe atopic dermatitis (AD) who are inadequately controlled by topical corticosteroids (TCS). The study includes a screening visit, a 2-week run-in period, a 12-week blinded treatment period, and an 8-week safety follow-up period. Following screening visit, eligible participants will enter in run-in period (Days − 14 to − 1) during which a protocol-specified topical therapy regimen will be initiated. At the end of the run-in period, participants who have: 1) demonstrated compliance with the protocol-specified TCS regimen, and 2) who continue to fulfill the eligibility criteria will be randomized.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: Lebrikizumab
    Lebrikizumab will be administered SC as per the schedule specified in the respective arms.
  • Drug: Placebo
    Placebo matching to lebrikizumab will be administered as per the schedule specified in the respective arms.
  • Drug: TCS Cream
    TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily
Study Arms  ICMJE
  • Experimental: Lebrikizumab 250 mg Single Dose + TCS Cream
    Participants will receive lebrikizumab 250 milligrams (mg) SC single dose on Day 1 followed by placebo on Week 4 and Week 8. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
    Interventions:
    • Drug: Lebrikizumab
    • Drug: Placebo
    • Drug: TCS Cream
  • Experimental: Lebrikizumab 125 mg Single Dose + TCS Cream
    Participants will receive lebrikizumab 125 mg SC single dose on Day 1 followed by placebo on Week 4 and Week 8. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
    Interventions:
    • Drug: Lebrikizumab
    • Drug: Placebo
    • Drug: TCS Cream
  • Experimental: Lebrikizumab 125 mg Q4W + TCS Cream
    Participants will receive lebrikizumab 125 mg SC every 4 weeks (Q4W) for a total of 3 doses. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
    Interventions:
    • Drug: Lebrikizumab
    • Drug: TCS Cream
  • Placebo Comparator: Placebo Q4W + TCS Cream
    Participants will receive placebo Q4W for a total of 3 doses. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
    Interventions:
    • Drug: Placebo
    • Drug: TCS Cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2016)
212
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2015)
200
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • AD diagnosed by the Hanifin/Rajka criteria and that has been present for at least 1 year at screening
  • Moderate to severe AD as graded by the Rajka/Langeland criteria at screening
  • History of inadequate response to a >/= 1 month (within the 3 months prior to the screening visit) treatment regimen of at least daily TCS and regular emollient for treatment of AD
  • EASI score >/= 14 at screening and end of the run-in period
  • IGA score >/= 3 (5-point scale) at screening and end of the run-in period
  • AD involvement of >/= 10% BSA at screening
  • Pruritus VAS score >/= 3 at screening

Exclusion Criteria:

  • Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab
  • Use of an investigational agent within 4 weeks prior to screening or within 5 half-lives of the investigational agent, whichever is longer
  • History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
  • Use of any complementary, alternative, or homeopathic medicines including, but not limited to, phytotherapies, traditional or non-traditional herbal medications, essential fatty acids, or acupuncture within 7 days prior to the run-in period or need for such medications during the study
  • Evidence of other skin conditions; including, but not limited to, T-cell lymphoma or allergic contact dermatitis
  • Evidence of, or ongoing treatment (including topical antibiotics) for active skin infection at screening
  • Other recent infections meeting protocol criteria
  • Active tuberculosis requiring treatment within the 12 months prior to Visit 1
  • Evidence of acute or chronic hepatitis or known liver cirrhosis
  • Known immunodeficiency, including human immunodeficiency virus (HIV) infection
  • Use of a topical calcineurin inhibitor (TCI) at the time of screening, unless the participant is willing to stop TCI use during the study (including the run-in period) and, in the investigator's opinion, it is safe to do so
  • Clinically significant abnormality on screening electrocardiogram (ECG) or laboratory tests that, in the opinion of the investigator, may pose an additional risk in administering study drug or TCS to the participant
  • Known current malignancy or current evaluation for a potential malignancy, including basal or squamous cell carcinoma of the skin or carcinoma in situ
  • History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Czechia,   Finland,   France,   Germany,   Korea, Republic of,   Netherlands,   Poland,   Spain,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02340234
Other Study ID Numbers  ICMJE GS29250
2014-000049-56 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP