Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis
NCT ID: NCT03568162
Last Updated: 2022-08-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
462 participants
INTERVENTIONAL
2018-05-31
2021-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ISB 830 - Part 1 Group 1
Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830.
ISB 830 - Part 1 Group 1
Subcutaneous injection (SC) every 2 weeks
ISB 830 - Part 1 Group 2
Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830 or placebo.
ISB 830 - Part 1 Group 2
Subcutaneous injection (SC) every 2 weeks
ISB 830 - Part 1 Group 3
Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830 or placebo.
ISB 830 - Part 1 Group 3
Subcutaneous injection (SC) every 2 weeks
Placebo - Part 1 Group 4
Subcutaneous (SC) administration of placebo, followed by SC maintenance dose of placebo.
Placebo - Part 1 Group 4
Subcutaneous injection (SC) every 2 weeks
ISB 830 - Part 2 Group 5
Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830.
ISB 830 - Part 2 Group 5
Subcutaneous injection (SC) every 2 weeks
Placebo - Part 2 Group 6
Subcutaneous (SC) administration of placebo, followed by SC maintenance dose of placebo.
Placebo - Part 2 Group 6
Subcutaneous injection (SC) every 2 weeks
Interventions
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ISB 830 - Part 1 Group 1
Subcutaneous injection (SC) every 2 weeks
ISB 830 - Part 1 Group 2
Subcutaneous injection (SC) every 2 weeks
ISB 830 - Part 1 Group 3
Subcutaneous injection (SC) every 2 weeks
Placebo - Part 1 Group 4
Subcutaneous injection (SC) every 2 weeks
ISB 830 - Part 2 Group 5
Subcutaneous injection (SC) every 2 weeks
Placebo - Part 2 Group 6
Subcutaneous injection (SC) every 2 weeks
Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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Glenmark Pharmaceuticals S.A.
INDUSTRY
Ichnos Sciences SA
INDUSTRY
Responsible Party
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Principal Investigators
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Andrea Acocella, MD, MBA
Role: STUDY_DIRECTOR
Ichnos Sciences
Locations
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Ichnos Investigational Site 129
Birmingham, Alabama, United States
Ichnos Investigational Site 120
Clovis, California, United States
Ichnos Investigational Site 105
Rolling Hills Estates, California, United States
Ichnos Investigational Site 106
Bridgeport, Connecticut, United States
Ichnos Investigational Site 146
Danbury, Connecticut, United States
Ichnos Investigational Site 142
Brandon, Florida, United States
Ichnos Investigational Site 143
Fort Myers, Florida, United States
Ichnos Investigational Site 148
Lake City, Florida, United States
Ichnos Investigational Site 141
Lake Worth, Florida, United States
Ichnos Investigational Site 140
Miami, Florida, United States
Ichnos Investigational Site 123
Miami, Florida, United States
Ichnos Investigational Site 147
Ormond Beach, Florida, United States
Ichnos Investigational site 101
Tampa, Florida, United States
Ichnos Investigational Site 135
Tampa, Florida, United States
Ichnos Investigational Site 115
Newnan, Georgia, United States
Ichnos Investigational Site 139
Savannah, Georgia, United States
Ichnos Investigational Site 112
Plainfield, Indiana, United States
Ichnos Investigational Site 125
West Des Moines, Iowa, United States
Ichnos Investigational Site109
New Orleans, Louisiana, United States
Ichnos Investigational Site 126
St Louis, Missouri, United States
Ichnos Investigational Site 144
Las Vegas, Nevada, United States
Ichnos Investigational Site 117
Verona, New Jersey, United States
Glenmark Investigational Site 102
Forest Hills, New York, United States
Ichnos Investigational Site 114
Medford, Oregon, United States
Ichnos Investigational Site 133
Hazleton, Pennsylvania, United States
Ichnos Investigational Site 122
Philadelphia, Pennsylvania, United States
Ichnos Investigational Site 132
Chattanooga, Tennessee, United States
Ichnos Investigational Site 119
Houston, Texas, United States
Ichnos Investigational Site 138
Pflugerville, Texas, United States
Ichnos Investigational Site 116
San Antonio, Texas, United States
Ichnos Investigational Site 110
Waco, Texas, United States
Ichnos Investigational Site 103
Newport News, Virginia, United States
Ichnos Investigational Site 131
Richmond, Virginia, United States
Ichnos Investigational Site 136
Spokane, Washington, United States
Ichnos Investigational Site 202
Calgary, Alberta, Canada
Ichnos Investigational Site 203
Surrey, British Columbia, Canada
Ichnos Investigational Site 207
Winnipeg, Manitoba, Canada
Ichnos Investigational Site 214
Hamilton, Ontario, Canada
Ichnos Investigational Site 204
Markham, Ontario, Canada
Ichnos Investigational Site 206
Ottawa, Ontario, Canada
Ichnos Investigational Site 208
Ottawa, Ontario, Canada
Ichnos Investigational Site 201
Richmond Hill, Ontario, Canada
Ichnos Investigational Site 211
Drummondville, Quebec, Canada
Ichnos Investigational Site 404
Brno, Brno-město, Czechia
Ichnos Investigational Site 402
Náchod, Královéhradecký kraj, Czechia
Ichnos Investigational Site 403
Prague, Praha 3, Czechia
Ichnos Investigational Site 401
Ostrava, , Czechia
Ichnos Investigational Site 405
Pardubice, , Czechia
Ichnos Investigational Site 407
Prague, , Czechia
Ichnos Investigational Site 406
Svitavy, , Czechia
Ichnos Investigational Site 313
Friedrichshafen, Baden-Wurttemberg, Germany
Ichnos Investigational Site 305
Langenau, Baden-Wurttemberg, Germany
Ichnos Investigational Site 311
Erlangen, Bavaria, Germany
Ichnos Investigational Site 314
Osnabrück, Lower Saxony, Germany
Ichnos Investigational Site 322
Bielefeld, North Rhine-Westphalia, Germany
Ichnos Investigational Site 318
Bochum, North Rhine-Westphalia, Germany
Ichnos Investigational Site 302
Dresden, Saxony, Germany
Ichnos Investigational Site 309
Dresden, Saxony, Germany
Ichnos Investigational Site 315
Lübeck, Schleswig-Holstein, Germany
Ichnos Investigational Site 319
Berlin, , Germany
Ichnos Investigational Site 304
Berlin, , Germany
Ichnos Investigational Site 326
Berlin, , Germany
Ichnos Investigational Site 310
Hamburg, , Germany
Ichnos Investigational Site 308
Hamburg, , Germany
Ichnos Investigational Site 518
Poznan, Greater Poland Voivodeship, Poland
Ichnos Investigational Site 514
Poznan, Greater Poland Voivodeship, Poland
Ichnos Investigational Site 502
Krakow, Lesser Poland Voivodeship, Poland
Ichnos Investigational Site 511
Krakow, Lesser Poland Voivodeship, Poland
Ichnos Investigational Site 510
Krakow, Lesser Poland Voivodeship, Poland
Ichnos Investigational Site 501
Krakow, Lesser Poland Voivodeship, Poland
Ichnos Investigational Site 504
Wroclaw, Lower Silesian Voivodeship, Poland
Ichnos Investigational Site 509
Warsaw, Masovian Voivodeship, Poland
Ichnos Investigational Site 521
Warsaw, Masovian Voivodeship, Poland
Ichnos Investigational Site 512
Warsaw, Masovian Voivodeship, Poland
Ichnos Investigational Site 506
Warsaw, Masovian Voivodeship, Poland
Ichnos Investigational Site 517
Iwonicz-Zdrój, Podkarpackie Voivodeship, Poland
Ichnos Investigational Site 519
Gdynia, Pomeranian Voivodeship, Poland
Ichnos Investigational Site 520
Gdynia, Pomeranian Voivodeship, Poland
Ichnos Investigational Site 513
Szczecin, West Pomeranian Voivodeship, Poland
Ichnos Investigational Site 503
Katowice, , Poland
Ichnos Investigational Site 505
Krakow, , Poland
Ichnos Investigational Site 508
Skarżysko-Kamienna, , Poland
Ichnos Investigational Site 507
Warsaw, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018-000783-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GBR 830-204
Identifier Type: -
Identifier Source: org_study_id
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