To Assess the Safety and Activity of GBR 830, Compared to Placebo, in Adults With Moderate-to-severe Atopic Dermatitis

NCT02683928 | Completed Phase 2 Results

• 1 other identifier: GBR 830-201
• Study Type: interventional
• Target: 64
• Locations: 2 countries
• Sites: 17

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events

  A treatment-emergent adverse event (TEAE) was defined as any new adverse event (AEs) or worsening of an existing condition after administration of the study drug up to and including the follow-up visit.

  16 weeks

• Change From Baseline in Thickness of Lesional Skin Biopsies

  Epidermal thickness was assessed in Hematoxylin and Eosin stained sections of lesional skin biopsies on Day 1 (baseline), Day 29, and Day 71.

  Day 1, before dosing (baseline), and Day 29 and Day 71, after dosing.

• 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

  Ratio of post-baseline/baseline value of messenger ribonucleic acid (mRNA) expression in lesional skin biopsies is reported.

  71 days

Secondary Outcomes (5)

• Percent Change in Eczema Area and Severity Index (EASI) Clinical Scores From Baseline

  Day 4, Day 29, Day 57, Day 71

• Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Clinical Score of 0 or 1

  Day 4, Day 29, Day 57, Day 71

• Pharmacokinetics of GBR 830 in Terms of Cmax After First and Second Dose.

  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

• Pharmacokinetics of GBR 830 in Terms of AUC0-tau After the First and Second Dose.

  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

• Number of Participants Positive or Negative for Anti-drug Antibodies (ADA) to GBR 830 to Evaluate Immunogenicity

  Samples collected for immunogenicity analysis at Baseline (pre-dose), and at Day 15, Day 29 (pre-dose), Day 57, and Day 85.

Study Arms (2)

GBR 830

EXPERIMENTAL

Two doses of GBR 830, 10 mg/kg (solution for infusion, prepared in normal saline) administered intravenously (IV) four weeks apart.

Biological: GBR 830

Placebo

PLACEBO COMPARATOR

Two doses of placebo (formulation buffer for infusion, prepared in normal saline) administered IV four weeks apart.

Biological: Placebo

Interventions

GBR 830 BIOLOGICAL

GBR 830

Placebo BIOLOGICAL

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ichnos Sciences SA: lead
• Glenmark Pharmaceuticals S.A.: collaborator

Study Sites (17)

Glenmark Investigational Site 14

Rogers, Arkansas, 72759, United States

Location

Glenmark Investigational Site 5

Los Angeles, California, 90045, United States

Location

Glenmark Investigational Site 3

San Diego, California, 92123, United States

Location

Glenmark Investigational Site 15

Tampa, Florida, 33624, United States

Location

Glenmark Investigational Site 11

St Louis, Missouri, 63117, United States

Location

Glenmark Investigational Site 16

Berlin, New Jersey, 08009, United States

Location

Glenmark Investigational Site 1

New York, New York, 10029, United States

Location

Glenmark Investigational Site 9

Raleigh, North Carolina, 27612, United States

Location

Glenmark Investigational Site 13

Fairborn, Ohio, 45324, United States

Location

Glenmark Investigational Site 2

Dallas, Texas, 75230, United States

Location

Glenmark Investigational Site 17

Katy, Texas, 77494, United States

Location

Glenmark Investigational Site 12

Webster, Texas, 77598, United States

Location

Glenmark Investigational Site 8

Markham, Ontario, L3P 1X2, Canada

Location

Glenmark Investigational Site 7

Peterborough, Ontario, K9J 5K2, Canada

Location

Glenmark Investigational Site 6

Richmond Hill, Ontario, L4C 9M7, Canada

Location

Glenmark Investigational Site 10

Waterloo, Ontario, N2J 1C4, Canada

Location

Glenmark Investigational Site 4

Montreal, Quebec, H2K 4L5, Canada

Location

Related Publications (1)

• 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.

  PMID: 30738171 RESULT

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Ichnos Sciences SA

clinicaltrialsdisclosuredesk@ichnossciences.com

2013314000

Study Officials

• Gerhard Wolff, MD

  Glenmark Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 17, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 18, 2020
• Results First Posted: May 18, 2020

Record last verified: 2020-05

Locations

US (12); CA (5)