Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 21 of 159 for:    Dermatitis, Atopic, 8

A Study of Lebrikizumab in Participants With Persistent 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: NCT02340234
Recruitment Status : Completed
First Posted : January 16, 2015
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Lebrikizumab Drug: Placebo Drug: TCS Cream Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
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.
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

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.
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

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.
Drug: Lebrikizumab
Lebrikizumab will be administered SC 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

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.
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Percent Change From Baseline in EASI Score at Week 12 [ Time Frame: Baseline, Week 12 ]
  2. Absolute Change From Baseline in EASI Score at Week 12 [ Time Frame: Baseline, Week 12 ]
  3. Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 12 [ Time Frame: Week 12 ]
  4. Percentage of Participants Achieving an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 12 [ Time Frame: Week 12 ]
  5. Percentage of Participants With a Greater Than or Equal to (>/=) 2 Point Reduction From Baseline in IGA at Week 12 [ Time Frame: Week 12 ]
  6. Absolute Change From Baseline in IGA at Week 12 [ Time Frame: Baseline, Week 12 ]
  7. Percentage of Participants Achieving an Investigator Global Signs Assessment (IGSA) Score of 0 or 1 at Week 12 [ Time Frame: Week 12 ]
  8. Percentage of Participants with a >/=2 Point Reduction From Baseline in IGSA at Week 12 [ Time Frame: Week 12 ]
  9. Absolute Change From Baseline in IGSA at Week 12 [ Time Frame: Baseline, Week 12 ]
  10. Percent Change From baseline in Severity Scoring of Atopic Dermatitis (SCORAD) at Week 12 [ Time Frame: Baseline, Week 12 ]
  11. Absolute Change From baseline in SCORAD at Week 12 [ Time Frame: Baseline, Week 12 ]
  12. Percentage of Participants With a 50% or 75% Reduction From Baseline in SCORAD-50/75 at Week 12 [ Time Frame: Week 12 ]
  13. Percentage of Participants Achieving EASI-50 at Week 12 and Maintaining EASI-50 at Weeks 16 [ Time Frame: Weeks 12, 16 ]
  14. Percentage of Participants Achieving EASI-50 at Week 12 and Maintaining EASI-50 at Weeks 16 and 20 [ Time Frame: Weeks 12, 16, 20 ]
  15. 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 ]
  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 ]
  17. 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 ]
  18. 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 ]
  19. Percentage of Participants Achieving SCORAD-50 at Week 12 and Maintaining SCORAD-50 at Weeks 16 [ Time Frame: Weeks 12, 16 ]
  20. Percentage of Participants Achieving SCORAD-50 at Week 12 and Maintaining SCORAD-50 at Weeks 16 and 20 [ Time Frame: Weeks 12, 16, 20 ]
  21. Percent Change From Baseline in Total % Body Surface Area (BSA) Affected At Week 12 [ Time Frame: Baseline, Week 12 ]
  22. Absolute Change From Baseline in Pruritus as Measured by the Pruritus Visual Analog Scale (VAS) at Week 12 [ Time Frame: Baseline, Week 12 ]
  23. Percent Change From Baseline in Pruritus as Measured by the Pruritus VAS at Week 12 [ Time Frame: Baseline, Week 12 ]
  24. Absolute Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12 [ Time Frame: Baseline, Week 12 ]
  25. Percent Change From Baseline in Pruritus as Measured by the 5-D Itch Scale at Week 12 [ Time Frame: Baseline, Week 12 ]
  26. Total Use (Grams) of TCS From Baseline to Week 12 [ Time Frame: From Baseline to Week 12 ]
  27. 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) ]
  28. Number of Disease Flares From Baseline to Week 12 [ Time Frame: From Baseline to Week 12 ]
  29. Change in AD Symptoms From Baseline to Week 12, as Assessed by the Atopic Dermatitis Symptom Diary (ADSD) [ Time Frame: Baseline, Week 12 ]
  30. 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 ]
  31. Change in Health-Related QoL From Baseline to Week 12, as Measured by the Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline, Week 12 ]
  32. 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) ]
  33. 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) ]
  34. 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) ]
  35. Percentage of Participants With Disease Rebound [ Time Frame: From Week 12 up to approximately 20 weeks ]
  36. Maximum Serum Concentration (Cmax) of Lebrikizumab [ Time Frame: After first dose of lebrikizumab at Week 1 ]
  37. Time to Reach Cmax (Tmax) of Lebrikizumab [ Time Frame: After first dose of lebrikizumab at Week 1 ]
  38. Minimum Serum Concentration (Cmin) of Lebrikizumab [ Time Frame: Pre-dose at Weeks 4, 8, 12 ]
  39. 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) ]


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:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02340234


  Show 74 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02340234     History of Changes
Other Study ID Numbers: GS29250
2014-000049-56 ( EudraCT Number )
First Posted: January 16, 2015    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
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
Hydrocortisone
Antibodies, Monoclonal
Anti-Inflammatory Agents
Immunologic Factors
Physiological Effects of Drugs