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Completed

NCT Number: NCT02340234

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St George Dermatology and Skin Cancer Centre, Kogarah, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lebrikizumab

Drug

Lebrikizumab will be administered SC as per the schedule specified in the respective arms.

Placebo

Drug

Placebo matching to lebrikizumab will be administered as per the schedule specified in the respective arms.

TCS Cream

Drug

TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 16, 2015
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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