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

A Phase 2 study testing GBR 830 in people with Atopic Dermatitis, run by Ichnos Sciences SA at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atopic Dermatitis
What is being tested?: GBR 830
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 17 sitesin 2 countries
Study dates: Mar 2016to Jun 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

17 sites in 2 countries.

Country

City, postcode or hospital

17 sites in 2 countries

United States12 sites

Glenmark Investigational Site 16
Berlin, New Jersey, 08009
Glenmark Investigational Site 2
Dallas, Texas, 75230
Glenmark Investigational Site 13
Fairborn, Ohio, 45324
Glenmark Investigational Site 17
Katy, Texas, 77494
Glenmark Investigational Site 5
Los Angeles, California, 90045
Glenmark Investigational Site 1
New York, New York, 10029
Glenmark Investigational Site 9
Raleigh, North Carolina, 27612
Glenmark Investigational Site 14
Rogers, Arkansas, 72759
Glenmark Investigational Site 3
San Diego, California, 92123
Glenmark Investigational Site 11
St Louis, Missouri, 63117
Glenmark Investigational Site 15
Tampa, Florida, 33624
Glenmark Investigational Site 12
Webster, Texas, 77598

Other trials in United States

Canada5 sites

Glenmark Investigational Site 8
Markham, Ontario, L3P 1X2
Glenmark Investigational Site 4
Montreal, Quebec, H2K 4L5
Glenmark Investigational Site 7
Peterborough, Ontario, K9J 5K2
Glenmark Investigational Site 6
Richmond Hill, Ontario, L4C 9M7
Glenmark Investigational Site 10
Waterloo, Ontario, N2J 1C4

Other trials in Canada

About this study

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

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
Being tested: GBR 830, Placebo
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GBR 830Biological
PlaceboBiological

Study groups in NCT02683928
Study group	Role	What they receive
GBR 830	Experimental	Two doses of GBR 830, 10 mg/kg (solution for infusion, prepared in normal saline) administered intravenously (IV) four weeks apart. Receives: Biological: GBR 830
Placebo	Placebo comparator	Two doses of placebo (formulation buffer for infusion, prepared in normal saline) administered IV four weeks apart. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 71 days

Secondary outcomes (5)

Percent Change in Eczema Area and Severity Index (EASI) Clinical Scores From Baseline
In EASI, four disease characteristics of atopic dermatitis (erythema, edema/papulation, excoriation, and lichenification) are assessed for severity on a scale of 0 (absent), 1 (mild), 2 (moderate), 3 (severe). The scores are added up for each of the four body regions (Head and neck, trunk, arms, and legs). The assigned percentages of body surface area (BSA) for each section of the body are 10% for head and neck, 20% for arms, 30% for trunk, and 40% for legs, respectively. Each subtotal score is multiplied by the BSA represented by that region. In addition, an area score of 0 to 6 is assigned for each body region, depending on the percentage of AD-affected skin in that area: 0 (none), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Each of the body area scores are multiplied by the area affected. The resulting EASI score ranges from 0 to 72 points, with the highest score indicating worse severity of AD.
Measured: 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
The IGA is an assessment scale used in clinical studies to determine severity of AD based on a 5-point scale ranging from 0 (clear) to 4 (severe/very severe).
Measured: Day 4, Day 29, Day 57, Day 71
Pharmacokinetics of GBR 830 in Terms of Cmax After First and Second Dose.
Pharmacokinetics in terms of Cmax (maximum observed concentration after second [last] dosing interval) was estimated after the first and second dose.
Measured: 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.
Pharmacokinetics in terms of AUC0-tau [Trapezoid calculation of area under the serum drug concentration-time curve from time zero (pre dose time point of the infusion) to the end of the dosing interval] was estimated.
Measured: 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
Blood samples were collected at time points to detect anti-drug antibodies (ADAs) to GBR 830, as per procedures similar to collection of PK samples. Antibodies of GBR 830 were detected and confirmed using a validated enzyme-linked immunosorbent assay (ELISA) method.
Measured: Samples collected for immunogenicity analysis at Baseline (pre-dose), and at Day 15, Day 29 (pre-dose), Day 57, and Day 85.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Jun 2017

First posted17 Feb 2016 (estimated)
Study startMar 2016
Primary completionJun 2017
Study completionJun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02683928
Sponsor's protocol ID: GBR 830-201
Status last verified: May 2020
First submitted: 4 Feb 2016
Last updated: 18 May 2020
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 30738171

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis

All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02683928
Acronym / sponsor ID: GBR 830-201
Conditions: Atopic Dermatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Ichnos Sciences SAIndustry (pharma, biotech, devices)
Collaborators: Glenmark Pharmaceuticals S.A.
Study start: Mar 2016 (actual)
Primary completion: Jun 2017 (actual)
Study completion: Jun 2017 (actual)
First posted: 17 Feb 2016 (estimated)
Results: Posted 18 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
GBR 830	Experimental	Biological: GBR 830Two doses of GBR 830, 10 mg/kg (solution for infusion, prepared in normal saline) administered intravenously (IV) four weeks apart.
Placebo	Placebo comparator	Biological: PlaceboTwo doses of placebo (formulation buffer for infusion, prepared in normal saline) administered IV four weeks apart.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GBR 830	Biological	GBR 830
Placebo	Biological	Placebo

Primary outcome

Incidence of Treatment-Emergent Adverse Events
Time frame: 16 weeks
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.
Change From Baseline in Thickness of Lesional Skin Biopsies
Time frame: Day 1, before dosing (baseline), and Day 29 and Day 71, after dosing.
Epidermal thickness was assessed in Hematoxylin and Eosin stained sections of lesional skin biopsies on Day 1 (baseline), Day 29, and Day 71.
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
Time frame: 71 days
Ratio of post-baseline/baseline value of messenger ribonucleic acid (mRNA) expression in lesional skin biopsies is reported.

5 secondary outcomes

Percent Change in Eczema Area and Severity Index (EASI) Clinical Scores From Baseline
Time frame: 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
Time frame: Day 4, Day 29, Day 57, Day 71
Pharmacokinetics of GBR 830 in Terms of Cmax After First and Second Dose.
Time frame: 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.
Time frame: 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
Time frame: Samples collected for immunogenicity analysis at Baseline (pre-dose), and at Day 15, Day 29 (pre-dose), Day 57, and Day 85.

Results and safety

Results posted to the registry on 18 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GBR 830	48	26
Placebo	16	8

Primary outcome: Incidence of Treatment-Emergent Adverse Events

Time frame: 16 weeks. Count of participants. Unit: Participants

Measure	GBR 830 n = 46	Placebo n = 16
experiencing at least 1 TEAE	29	10
experiencing at least 1 SAE	1	0
TEAE leading to permanent withdrawal of study drug	2	1
TEAE related to study drug	4	4

Population analysed: The Safety Analysis Set consisted of all participants who took at least 1 full or partial dose of study treatment and were used in the assessment and reporting of safety data.

Primary outcome: Change From Baseline in Thickness of Lesional Skin Biopsies

Time frame: Day 1, before dosing (baseline), and Day 29 and Day 71, after dosing.. Mean (Standard Deviation). Unit: micrometer

Measure	GBR 830 n = 29	Placebo n = 11
Baseline	140.56 (57.623)	124.95 (47.021)
Change from Baseline in H&E Thickness to Day 29	-14.90 (57.787)	-3.02 (51.589)
Change from Baseline in H&E Thickness to Day 71	-26.51 (88.676)	-6.01 (39.402)

Population analysed: The Biological Activity Set (BAS) consisted of all FAS subjects who had at least 1 post-baseline skin biopsy (Visit 7, Visit 13), and received 2 doses of study drug. The primary analyses on biomarkers of disease activity obtained from biopsy were based on the BAS. Subjects were analyzed according to the treatment to which they were randomized.

Primary outcome: 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

Time frame: 71 days. Geometric least squares mean (95% Confidence Interval). Unit: ratio

Measure	GBR 830 n = 29	Placebo n = 11
CCL11/hARP	0.67 (0.40 to 1.13)	1.20 (0.5 to 2.9)
CCL17/hARP	0.62 (0.38 to 1.01)	0.75 (0.34 to 1.67)
CCL18/hARP	0.75 (0.59 to 0.96)	0.64 (0.43 to 0.96)
CCL26/hARP	0.81 (0.63 to 1.03)	0.67 (0.45 to 1.01)
CXCL10/hARP	0.53 (0.36 to 0.79)	0.85 (0.45 to 1.63)
FOXP3/hARP	0.88 (0.77 to 1.02)	0.93 (0.74 to 1.16)
INFg/hARP	0.77 (0.48 to 1.23)	1.34 (0.62 to 2.91)
IL-23p40/hARP	0.74 (0.52 to 1.04)	0.71 (0.41 to 1.23)

Population analysed: The Biological Activity Set (BAS) consisted of all FAS participants who had at least 1 post-baseline skin biopsy (Visit 7, Visit 13), and received 2 doses of drug. The primary analyses on biomarkers of disease activity obtained from biopsy were based on the BAS. Participants were analyzed according to the treatment to which they were randomized.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs and SAEs were collected from the time of signing the informed consent form (ICF) until the follow up for a total duration of 16 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GBR 830	1 of 46 (2.2%)	21 of 46 (45.7%)	0 of 46
Placebo	0 of 16 (0%)	10 of 16 (62.5%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30738171Guttman-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.

Related trials for Atopic Dermatitis

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gerhard Wolff, MD study director

Glenmark Pharmaceuticals S.A.

17 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GBR 830 in people with Atopic Dermatitis, run by Ichnos Sciences SA at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02683928, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.