Clinical trial NCT02683928: To Assess the Safety and Activity of GBR 830, Compared to Placebo, in Adults With Moderate-to-severe Atopic Dermatitis
Official title: A Phase IIa, Double-Blind, Randomised, Placebo-controlled, Exploratory Study to Evaluate the Safety, Biological Activity and Pharmacokinetics of GBR 830 in Adults With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Ichnos Sciences SA
Sponsor class: INDUSTRY
Collaborators: name: Glenmark Pharmaceuticals S.A.
First posted: 2016-02-17
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of GBR 830 on biomarkers in atopic dermatitis to enable further studies in this indication.


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years or older
* Atopic dermatitis involvement that of at least 10% body surface area

Exclusion Criteria:

* Treatment with systemic corticosteroids within 4 weeks before randomization, and topical steroids, tacrolimus and/or pimecrolimus within 1 week before the randomization (except emollients, and mild steroids (class 6 or 7)
* Any cell-depleting agents including but not limited to rituximab: within 6 months prior to the baseline visit or until lymphocyte and CD 19+ lymphocyte counts return to normal, whichever is longer. Other biologics: within 5 half-lives or 8 weeks prior to the baseline visit, whichever is longer. Allergen immunotherapy within 6 months before the baseline visit.
* Patient with history of serious local infection and systemic infection Patient with history or current evidence of diseases such as tuberculosis, malignant disease, other inflammatory or autoimmune disease or HIV or Hepatitis B or C positive.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 16 weeks
measure: Change From Baseline in Thickness of Lesional Skin Biopsies
timeFrame: Day 1, before dosing (baseline), and Day 29 and Day 71, after dosing.
measure: Change From Baseline in Ratio of Active Atopic Dermatitis Messenger Ribonucleic Acid (mRNA) Expression (Normalized to Human Acidic Ribosomal Protein [hARP]) in Lesional Skin Biopsies
timeFrame: 71 days
Secondary outcomes:
measure: Percent Change in Eczema Area and Severity Index (EASI) Clinical Scores From Baseline
timeFrame: Day 4, Day 29, Day 57, Day 71
measure: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Clinical Score of 0 or 1
timeFrame: Day 4, Day 29, Day 57, Day 71
measure: Pharmacokinetics of GBR 830 in Terms of Cmax After First and Second Dose.
timeFrame: Blood samples were collected on Day 1 and Day 29: pre-dose (15 mins), end of infusion (1 hour) and 1.5, 2, 72, and 504 hours post start of infusion
measure: Pharmacokinetics of GBR 830 in Terms of AUC0-tau After the First and Second Dose.
timeFrame: Blood samples were collected on Day 1 and Day 29: pre-dose (15 mins), end of infusion (1 hour) and 1.5, 2, 72, and 504 hours post start of infusion
measure: Number of Participants Positive or Negative for Anti-drug Antibodies (ADA) to GBR 830 to Evaluate Immunogenicity
timeFrame: Samples collected for immunogenicity analysis at Baseline (pre-dose), and at Day 15, Day 29 (pre-dose), Day 57, and Day 85.
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Glenmark Investigational Site 14
state: Arkansas
city: Los Angeles
country: United States
facility: Glenmark Investigational Site 5
state: California
city: San Diego
country: United States
facility: Glenmark Investigational Site 3
state: California
city: Tampa
country: United States
facility: Glenmark Investigational Site 15
state: Florida
city: Saint Louis
country: United States
facility: Glenmark Investigational Site 11
state: Missouri
city: Berlin
country: United States
facility: Glenmark Investigational Site 16
state: New Jersey
city: New York
country: United States
facility: Glenmark Investigational Site 1
state: New York
city: Raleigh
country: United States
facility: Glenmark Investigational Site 9
state: North Carolina
city: Fairborn
country: United States
facility: Glenmark Investigational Site 13
state: Ohio
city: Dallas
country: United States
facility: Glenmark Investigational Site 2
state: Texas
city: Katy
country: United States
facility: Glenmark Investigational Site 17
state: Texas
city: Webster
country: United States
facility: Glenmark Investigational Site 12
state: Texas
city: Markham
country: Canada
facility: Glenmark Investigational Site 8
state: Ontario
city: Peterborough
country: Canada
facility: Glenmark Investigational Site 7
state: Ontario
city: Richmond Hill
country: Canada
facility: Glenmark Investigational Site 6
state: Ontario
city: Waterloo
country: Canada
facility: Glenmark Investigational Site 10
state: Ontario
city: Montreal
country: Canada
facility: Glenmark Investigational Site 4
state: Quebec
Study officials:
affiliation: Glenmark Pharmaceuticals
name: Gerhard Wolff, MD
role: STUDY_DIRECTOR
References:
citation: Guttman-Yassky E, Pavel AB, Zhou L, Estrada YD, Zhang N, Xu H, Peng X, Wen HC, Govas P, Gudi G, Ca V, Fang H, Salhi Y, Back J, Reddy V, Bissonnette R, Maari C, Grossman F, Wolff G. GBR 830, an anti-OX40, improves skin gene signatures and clinical scores in patients with atopic dermatitis. J Allergy Clin Immunol. 2019 Aug;144(2):482-493.e7. doi: 10.1016/j.jaci.2018.11.053. Epub 2019 Feb 6.