A Study of Lebrikizumab in Patients with Persistent Moderate to Severe Atopic Dermatitis

• Register: EUCTR
• Last refreshed on: 17 May 2016
• Main ID: EUCTR2014-000049-56-ES
• Date of registration: 27/03/2015
• Prospective Registration: Yes
• Primary sponsor: Roche Farma, S.A. , en nombre de F. Hoffmann- La Roche
• Public title: A Study of Lebrikizumab in Patients with Persistent Moderate to Severe Atopic Dermatitis
• Scientific title: A phase II, randomised, 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
• Date of first enrolment: 06/05/2015
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000049-56
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Run-in period If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Canada, Czech Republic, Finland, France, Germany, Korea, Republic of, Netherlands, Poland, Spain, Switzerland, Taiwan, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
- Age 18 to 75 years, inclusive, at the start of the run-in period
- 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
- IGA score >/= 3
- AD involvement of >/= 10% body surface area
- Pruritus Visual Analog Scale score >/= 3
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 198
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion criteria:
- Past and/or current use of any anti-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
- Evidence of other skin conditions, including, but not limited to, T-cell lymphoma or allergic contact dermatitis
- 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 HIV infection
- Use of a topical calcineurin inhibitor (TCI) at the time of screening, unless the patient is willing to stop TCI use during the study (including the run-in period) and, in the investigators opinion, it is safe to do so
- Clinically significant abnormality on screening ECG or laboratory tests
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Atopic Dermatitis
MedDRA version: 17.1 Level: PT Classification code 10012438 Term: Dermatitis atopic System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Intervention(s)

Product Name: lebrikizumab
Product Code: RO5490255/F01-02
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: LEBRIKIZUMAB
Current Sponsor code: RO5490255
Other descriptive name: TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Trade Name: Hydrocortisone cream USP, 2.5%
Pharmaceutical Form: Cream
INN or Proposed INN: HYDROCORTISONE
Current Sponsor code: RO0079351
Concentration unit: % percent
Concentration type: equal
Concentration number: 2.5-

Trade Name: triamcinolone Acetonide cream USP, 0.1%
Pharmaceutical Form: Cream
INN or Proposed INN: TRIAMCINOLONE ACETONIDE
Current Sponsor code: RO0058382
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.1-

Primary Outcome(s)

Main Objective: The primary objective of this study is to evaluate the efficacy and safety of lebrikizumab used as adjunctive therapy with topical corticosteroid (TCS) compared with TCS alone in patients with persistent moderate to severe atopic dermatitis.

Timepoint(s) of evaluation of this end point: From Baseline to Week 12

Secondary Objective: To evaluate the efficacy of lebrikizumab adjunctive therapy with TCS compared with TCS alone, as measured by AD symptoms, including pruritis, and AD-specific health-related quality of life.
? To evaluate the pharmacokinetics and immunogenicity of lebrikizumab administered by subcutaneous (SC) injection
? To evaluate AD-related biomarkers and the effect on their expression from lebrikizumab used as adjunctive therapy with TCS compared with TCS

Primary end point(s): Percentage of patients achieving a 50% reduction in Eczema Area and Severity Index (EASI) score (EASI-50) from baseline to Week 12

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1 to 3. From Baseline to Week 12
4. Up to Week 20

Secondary end point(s): 1. Outcome Measure: Efficacy (composite outcome measure): Percent and absolute change from baseline in EASI score at Week 12
2. Outcome Measure: Percent of patients achieving an Investigators Global Assessment (IGA) score of 0 or 1 at Week 12
3. Outcome Measure: Efficacy (composite outcome measure): Percent and absolute change from baseline in Severity Scoring of Atopic Dermatitis (SCORAD) at Week 12
4. Outcome Measure: Frequency and severity of treatment-emergent adverse events

Secondary ID(s)

GS29250

2014-000049-56-DE

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd