Clinical trial NCT03568162: Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of ISB 830 in Adult Subjects With Moderate to Severe Atopic Dermatitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate to Severe Atopic Dermatitis
Keywords: ISB 830, OX40, atopic dermatitis
Lead sponsor: Ichnos Sciences SA
Sponsor class: INDUSTRY
Collaborators: name: Glenmark Pharmaceuticals S.A.
First posted: 2018-06-26
Enrollment: 462
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: Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate the efficacy, safety and tolerability of ISB 830 in adults with moderate to severe atopic dermatitis. The study will be conducted in 2 Parts, with dosing Groups 1-4 comprising Part 1, and dosing Groups 5-6 comprising Part 2. All subjects will receive open-label ISB 830 after a 16 week blinded treatment period.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged ≥18 years with physician diagnosis of atopic dermatitis for \>1 year as defined by American Academy of Dermatology Consensus Criteria.
* Atopic dermatitis involvement of ≥10% of body surface area at screening and baseline.
* EASI score of ≥12 at screening or ≥16 at baseline.
* IGA score of ≥3 at screening and baseline (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe)
* Baseline Pruritus Numerical Rating Scale (NRS) score for maximum itch intensity ≥3 over the previous 24 hours.

Exclusion Criteria:

* Pregnant or lactating women.
* Prior treatment with ISB 830
* Treatment with biologics
* Systemic corticosteroids, immunosuppressive/immunomodulatory drugs or phototherapy within 4 weeks of baseline
* Active chronic or acute infection requiring systemic treatment

Primary outcomes:
measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Clinical Score at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving Both Investigator's Global Assessment (IGA) Clinical Score of 0 or 1 and an IGA Reduction From Baseline of ≥ 2 Points at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants With Improvement (Reduction) in Pruritus Numerical Rating Scale (NRS) Score of ≥ 4 From Baseline at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving a 50% Reduction From Baseline in EASI Score (EASI-50) at Week 16
timeFrame: Baseline, Week 16
measure: Percent Change From Baseline in SCORAD Score at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Global Individual Signs Score (GISS) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale Scores at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Patient Global Assessment (PGA) of Disease and Treatment at Week 16
timeFrame: Baseline, Week 16
measure: Percentage Change From Baseline in PGA of Disease and Treatment at Week 16
timeFrame: Baseline, Week 16
measure: Number of Missed Work or School Days at Week 16
timeFrame: Week 16
measure: Maximum Observed Serum Concentration (Cmax) of ISB 830
timeFrame: Predose (within 15 minutes prior to dose), 4, 24, 96, 120, 168, and 336 hours postdose on Day 1 and predose (within 15 minutes prior to dose), 4, 24, 96, 120, and 168 hours postdose on Day 85
measure: Area Under Curve From Time Zero to the End of Dosing Interval (AUC0-tau)
timeFrame: Predose (within 15 minutes prior to dose), 4, 24, 96, 120, 168, and 336 hours postdose on Day 1 and predose (within 15 minutes prior to dose), and at 4, 24, 96, 120, 168 hours postdose on Day 85
measure: Percentage of Participants With Anti-Drug Antibody (ADA) at Week 16
timeFrame: Baseline through Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Ichnos Investigational Site 129
state: Alabama
city: Clovis
country: United States
facility: Ichnos Investigational Site 120
state: California
city: Rolling Hills Estates
country: United States
facility: Ichnos Investigational Site 105
state: California
city: Bridgeport
country: United States
facility: Ichnos Investigational Site 106
state: Connecticut
city: Danbury
country: United States
facility: Ichnos Investigational Site 146
state: Connecticut
city: Brandon
country: United States
facility: Ichnos Investigational Site 142
state: Florida
city: Fort Myers
country: United States
facility: Ichnos Investigational Site 143
state: Florida
city: Lake City
country: United States
facility: Ichnos Investigational Site 148
state: Florida
city: Lake Worth
country: United States
facility: Ichnos Investigational Site 141
state: Florida
city: Miami
country: United States
facility: Ichnos Investigational Site 140
state: Florida
city: Miami
country: United States
facility: Ichnos Investigational Site 123
state: Florida
city: Ormond Beach
country: United States
facility: Ichnos Investigational Site 147
state: Florida
city: Tampa
country: United States
facility: Ichnos Investigational site 101
state: Florida
city: Tampa
country: United States
facility: Ichnos Investigational Site 135
state: Florida
city: Newnan
country: United States
facility: Ichnos Investigational Site 115
state: Georgia
city: Savannah
country: United States
facility: Ichnos Investigational Site 139
state: Georgia
city: Plainfield
country: United States
facility: Ichnos Investigational Site 112
state: Indiana
city: West Des Moines
country: United States
facility: Ichnos Investigational Site 125
state: Iowa
city: New Orleans
country: United States
facility: Ichnos Investigational Site109
state: Louisiana
city: Saint Louis
country: United States
facility: Ichnos Investigational Site 126
state: Missouri
city: Las Vegas
country: United States
facility: Ichnos Investigational Site 144
state: Nevada
city: Verona
country: United States
facility: Ichnos Investigational Site 117
state: New Jersey
city: Forest Hills
country: United States
facility: Glenmark Investigational Site 102
state: New York
city: Medford
country: United States
facility: Ichnos Investigational Site 114
state: Oregon
city: Hazleton
country: United States
facility: Ichnos Investigational Site 133
state: Pennsylvania
city: Philadelphia
country: United States
facility: Ichnos Investigational Site 122
state: Pennsylvania
city: Chattanooga
country: United States
facility: Ichnos Investigational Site 132
state: Tennessee
city: Houston
country: United States
facility: Ichnos Investigational Site 119
state: Texas
city: Pflugerville
country: United States
facility: Ichnos Investigational Site 138
state: Texas
city: San Antonio
country: United States
facility: Ichnos Investigational Site 116
state: Texas
city: Waco
country: United States
facility: Ichnos Investigational Site 110
state: Texas
city: Newport News
country: United States
facility: Ichnos Investigational Site 103
state: Virginia
city: Richmond
country: United States
facility: Ichnos Investigational Site 131
state: Virginia
city: Spokane
country: United States
facility: Ichnos Investigational Site 136
state: Washington
city: Calgary
country: Canada
facility: Ichnos Investigational Site 202
state: Alberta
city: Surrey
country: Canada
facility: Ichnos Investigational Site 203
state: British Columbia
city: Winnipeg
country: Canada
facility: Ichnos Investigational Site 207
state: Manitoba
city: Hamilton
country: Canada
facility: Ichnos Investigational Site 214
state: Ontario
city: Markham
country: Canada
facility: Ichnos Investigational Site 204
state: Ontario
city: Ottawa
country: Canada
facility: Ichnos Investigational Site 206
state: Ontario
city: Ottawa
country: Canada
facility: Ichnos Investigational Site 208
state: Ontario
city: Richmond Hill
country: Canada
facility: Ichnos Investigational Site 201
state: Ontario
city: Drummondville
country: Canada
facility: Ichnos Investigational Site 211
state: Quebec
city: Brno
country: Czechia
facility: Ichnos Investigational Site 404
state: Brno-město
city: Náchod
country: Czechia
facility: Ichnos Investigational Site 402
state: Královéhradecký Kraj
city: Praha
country: Czechia
facility: Ichnos Investigational Site 403
state: Praha 3
city: Ostrava
country: Czechia
facility: Ichnos Investigational Site 401
city: Pardubice
country: Czechia
facility: Ichnos Investigational Site 405
city: Praha 1
country: Czechia
facility: Ichnos Investigational Site 407
city: Svitavy
country: Czechia
facility: Ichnos Investigational Site 406
city: Friedrichshafen
country: Germany
facility: Ichnos Investigational Site 313
state: Baden-Württemberg
city: Langenau
country: Germany
facility: Ichnos Investigational Site 305
state: Baden-Württemberg
city: Erlangen
country: Germany
facility: Ichnos Investigational Site 311
state: Bayern
city: Osnabrück
country: Germany
facility: Ichnos Investigational Site 314
state: Niedersachsen
city: Bielefeld
country: Germany
facility: Ichnos Investigational Site 322
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: Ichnos Investigational Site 318
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Ichnos Investigational Site 302
state: Sachsen
city: Dresden
country: Germany
facility: Ichnos Investigational Site 309
state: Sachsen
city: Lübeck
country: Germany
facility: Ichnos Investigational Site 315
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Ichnos Investigational Site 319
city: Berlin
country: Germany
facility: Ichnos Investigational Site 304
city: Berlin
country: Germany
facility: Ichnos Investigational Site 326
city: Hamburg
country: Germany
facility: Ichnos Investigational Site 310
city: Hamburg
country: Germany
facility: Ichnos Investigational Site 308
city: Wroclaw
country: Poland
facility: Ichnos Investigational Site 504
state: Dolnoslaskie
city: Krakow
country: Poland
facility: Ichnos Investigational Site 511
state: Malopolskie
city: Krakow
country: Poland
facility: Ichnos Investigational Site 510
state: Malopolskie
city: Kraków
country: Poland
facility: Ichnos Investigational Site 502
state: Malopolskie
city: Kraków
country: Poland
facility: Ichnos Investigational Site 501
state: Malopolskie
city: Warszawa
country: Poland
facility: Ichnos Investigational Site 509
state: Mazowieckie
city: Warszawa
country: Poland
facility: Ichnos Investigational Site 521
state: Mazowieckie
city: Warszawa
country: Poland
facility: Ichnos Investigational Site 512
state: Mazowieckie
city: Warszawa
country: Poland
facility: Ichnos Investigational Site 506
state: Mazowieckie
city: Iwonicz-Zdrój
country: Poland
facility: Ichnos Investigational Site 517
state: Podkarpackie
city: Gdynia
country: Poland
facility: Ichnos Investigational Site 519
state: Pomorskie
city: Gdynia
country: Poland
facility: Ichnos Investigational Site 520
state: Pomorskie
city: Poznań
country: Poland
facility: Ichnos Investigational Site 518
state: Wielkopolskie
city: Poznań
country: Poland
facility: Ichnos Investigational Site 514
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Ichnos Investigational Site 513
state: Zachodniopomorskie
city: Katowice
country: Poland
facility: Ichnos Investigational Site 503
city: Kraków
country: Poland
facility: Ichnos Investigational Site 505
city: Skarzysko-Kamienna
country: Poland
facility: Ichnos Investigational Site 508
city: Warszawa
country: Poland
facility: Ichnos Investigational Site 507
Study officials:
affiliation: Ichnos Sciences
name: Andrea Acocella, MD, MBA
role: STUDY_DIRECTOR
References: