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Clinical Trial Details for Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis


Ichnos Sciences SA
NCT ID: NCT03568162
Last Updated: March 27, 2020

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 2
  • Gender: All
  • Age: 18 Years - N/A
  • Condition: Moderate to Severe Atopic Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Ichnos Sciences SA
  • Location: Not Provided

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of ISB 830 in Adult Subjects With Moderate to Severe Atopic Dermatitis.

Purpose

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

Ages Eligible for Study

18 Years to N/A

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Additional Information, Locations & Contacts

Sponsors & Collaborators

Ichnos Sciences SA

Glenmark Pharmaceuticals S.A.

Investigators

Study Director: Andrea Acocella, MD, MBA

Ichnos Sciences

Please refer to this study by its ClinicalTrials.gov identifier: NCT03568162

Location

Contacts

Glenmark Investigational Site 129

Birmingham, Alabama 35209

United States

Glenmark Investigational Site 120

Clovis, California 93711

United States

Marketa Limova, MD

Shaunna@Sierra-Med.com

Glenmark Investigational Site 124

Long Beach, California 90808

United States

Glenmark Investigational Site 105

Rolling Hills Estates, California 90274

United States

Glenmark Investigational Site 118

Santa Monica, California 90404

United States

Glenmark Investigational Site 106

Bridgeport, Connecticut 06606

United States

Glenmark Investigational Site 146

Danbury, Connecticut 06810

United States

william notaro, MD

wnotaro@danburyclinical.com

Glenmark Investigational Site 142

Brandon, Florida 33511

United States

Mariam Abreu-ruiz, MD

dr.abreu@crtfi.com

Glenmark Investigational Site 143

Fort Myers, Florida 33912

United States

Anais Badia, MD

anais.badia@amrllc.com

Glenmark Investigational Site 148

Lake City, Florida 32055

United States

miguel tepedino, MD

drmtepedino@msrainc.com

Glenmark Investigational Site 141

Lake Worth, Florida 33461

United States

Thomas Ross, MD

tross@altusresearch.com

Glenmark Investigational Site 140

Miami, Florida 33156

United States

david rodriguez, MD

darmd1@aol.com

Glenmark Investigational Site 123

Miami, Florida 33175

United States

Glenmark Investigational Site 147

Ormond Beach, Florida 32174

United States

Glenmark Investigational Site 127

Pensacola, Florida 32504

United States

Glenmark Investigational site 101

Tampa, Florida 33607

United States

Sady Alpizar, MD

s.alpizar.md@crtfi.com

Glenmark Investigational Site 135

Tampa, Florida 33612

United States

Glenmark Investigational Site 115

Newnan, Georgia 30263

United States

Glenmark Investigational Site 139

Savannah, Georgia 31406

United States

Glenmark Investigational Site 112

Plainfield, Indiana 46168

United States

Glenmark Investigational Site 125

West Des Moines, Iowa 50265

United States

James Coggi, MD

kmajors@ictsiowa.com

Glenmark Investigational Site109

New Orleans, Louisiana 70115

United States

Deirdre Hooper, MD

thastings@delricht.com

Glenmark Investigational Site 126

Saint Louis, Missouri 63141

United States

Ann Martin, MD

amartin@wustl.edu

Glenmark Investigational Site 144

Las Vegas, Nevada 89120

United States

Yadwinder Dhillon, MD

y.dhillon@viableresearch.org

Glenmark Investigational Site 117

Verona, New Jersey 07044-2946

United States

Robert Nossa, MD

mjohnson@thedermgroup.com

Glenmark Investigational Site 102

Forest Hills, New York 11375

United States

Jeffrey Weinberg, MD

jmw27@columbia.edu

Glenmark Investigational Site 114

Medford, Oregon 97504-9741

United States

Edward Kerwin, MD

ekerwin@criresearch.com

Glenmark Investigational Site 133

Hazleton, Pennsylvania 18201

United States

Stephen Schleicher

cutismd@aol.com

Glenmark Investigational Site 122

Philadelphia, Pennsylvania 19103

United States

Glenmark Investigational Site 132

Chattanooga, Tennessee 37421

United States

Glenmark Investigational Site 119

Houston, Texas 77004

United States

Stephen Tyring, MD

lcgarcia@ccstexas.com

Glenmark Investigational Site 138

Pflugerville, Texas 78660

United States

Edward Lain, MD

patricia@atxresearch.com

Glenmark Investigational Site 116

San Antonio, Texas 78258

United States

Brian MacGillivray, MD

drmac@mydrmac.com

Glenmark Investigational Site 110

Waco, Texas 76710

United States

Glenmark Investigational Site 103

Newport News, Virginia 23606-4537

United States

Chester "Tim" Fisher, MD

natalie@btcsites.com

Glenmark Investigational Site 131

Richmond, Virginia 23220

United States

Glenmark Investigational Site 136

Spokane, Washington 99224

United States

Werschler William, MD

Riley@clin-edge.com

Glenmark Investigational Site 609

Sevlievo, Gabrovo 5400

Bulgaria

Glenmark Investigational Site 603

Sofia, Sofia-grad 1113

Bulgaria

Glenmark Investigational Site 608

Sofia, Sofia-grad 1407

Bulgaria

Glenmark Investigational Site 601

Sofia, Sofia-grad 1510

Bulgaria

Glenmark Investigational Site 602

Dupnitsa, 2600

Bulgaria

Glenmark Investigational Site 606

Pleven, 5800

Bulgaria

Glenmark Investigational Site 604

Plovdiv, 4002

Bulgaria

Glenmark Investigational Site 607

Ruse, 7000

Bulgaria

Glenmark Investigational Site 605

Sofia, 1463

Bulgaria

Glenmark Investigational Site 202

Calgary, Alberta T3A 2N1

Canada

Andrei Metelitsa, MD

andrei.metelitsa@gmail.com

Glenmark Investigational Site 203

Surrey, British Columbia V3V 0C6

Canada

Lorne Albrecht, MD

lalbrecht@enverusmedical.com

Glenmark Investigational Site 207

Winnipeg, Manitoba R3M 3Z4

Canada

Marni Wiseman

mwiseman@skinwise.ca

Glenmark Investigational Site 212

Saint John's, Newfoundland and Labrador A1C2H5

Canada

Glenmark Investigational Site 214

Hamilton, Ontario L8N 3Z5

Canada

Michael Cyr, MD

Glenmark Investigational Site 204

Markham, Ontario L3P 1X2

Canada

Charles Lynde, MD

derma@lynderma.com

Glenmark Investigational Site 206

Ottawa, Ontario K1G 6C6

Canada

William Yang, MD

wyang@yangmedicine.com

Glenmark Investigational Site 208

Ottawa, Ontario K2C 3N2

Canada

Michael Robern

mrobern@magma.ca

Glenmark Investigational Site 201

Richmond Hill, Ontario L4C 9M7

Canada

Afsaneh Alavi, MD

dr.alavi@afsanehalavi.com

Glenmark Investigational Site 211

Drummondville, Quebec QC, J2B 5L

Canada

Delorme Isabelle, MD

docteure@dredelorme.com

Glenmark Investigational Site 404

Brno, Brno-město 602 00

Czechia

Nadezda Fiserova, MD

RFI.Brno@bioclinica.com

Glenmark Investigational Site 402

Náchod, Královéhradecký Kraj 547 01

Czechia

Romana Machackova, MD

romana.machackova@seznam.cz

Glenmark Investigational Site 403

Praha, Praha 3 130 00

Czechia

Martina Machkova, MD

RFI.Prague@bioclinica.com

Glenmark Investigational Site 401

Ostrava, 702 00

Czechia

Glenmark Investigational Site 405

Pardubice, 530 02

Czechia

Glenmark Investigational Site 407

Praha 1, 110 00

Czechia

Petr Arenberger

avemedica@email.cz

Glenmark Investigational Site 406

Svitavy, 568 02

Czechia

Petr Trestik

ptrestik@seznam.cz

Glenmark Investigational Site 312

Friedrichshafen, Baden-Württemberg 88045

Germany

Glenmark Investigational Site 313

Friedrichshafen, Baden-Württemberg 88045

Germany

Charlotte Baronin von Engelhardt, MD

engelhardt@kfsn.de

Glenmark Investigational Site 305

Langenau, Baden-Württemberg 89129

Germany

Glenmark Investigational Site 311

Erlangen, Bayern 91054

Germany

Michael Sticherling, MD

michael.sticherling@uk-erlangen.de

Glenmark Investigational Site 306

Munich, Bayern 80802

Germany

Glenmark Investigational Site 301

Mahlow, Brandenburg 15831

Germany

Glenmark Investigational Site 316

Frankfurt/main, Hessen 60590

Germany

Glenmark Investigational Site 317

Giesen, Hessen 35390

Germany

Glenmark Investigational Site 323

Hannover, Niedersachsen 30625

Germany

Glenmark Investigational Site 314

Osnabrück, Niedersachsen 49074

Germany

Sylvia Pauser, MD

sylvia.pauser@klifos.de

Glenmark Investigational Site 322

Bielefeld, Nordrhein-Westfalen 33647

Germany

Glenmark Investigational Site 318

Bochum, Nordrhein-Westfalen 44793

Germany

Niesmann Johannes, MD

johannes.niesmann@rub.de

Glenmark Investigational Site 321

Bonn, Nordrhein-Westfalen 53105

Germany

Glenmark Investigational Site 320

Mainz, Rheinland-Pfalz 55131

Germany

Glenmark Investigational Site 302

Dresden, Sachsen 01097

Germany

Beatrice Gerlach, MD

dr.b.gerlach@t-online.de

Glenmark Investigational Site 309

Dresden, Sachsen 1069

Germany

Peter Heymer, MD

heymer@kfdd.de

Glenmark Investigational Site 315

Lübeck, Schleswig-Holstein 23538

Germany

Thaci Diamant, MD

yves.trense@uksh.de

Glenmark Investigational Site 319

Berlin, 10117

Germany

Worm Margitta, MD

ctmu@charite.de

Glenmark Investigational Site 304

Berlin, 10789

Germany

Margrit Simon, MD

info@isa-research.de

Glenmark Investigational Site 326

Berlin, 14050

Germany

Rainard Fuhr, MD

sandra.stark@parexel.com

Glenmark Investigational Site 310

Hamburg, 22143

Germany

Glenmark Investigational Site 308

Hamburg, 22391

Germany

Swarna Ekanayake-Bohlig, MD

ekanayake@mensing-derma.de

Glenmark Investigational Site 702

Kaunas, Kauno Apskritis 50009

Lithuania

Glenmark Investigational Site 706

Kaunas, Kauno Apskritis LT-50009

Lithuania

Glenmark Investigational Site 701

Klaipėda, Klaipedos Apskritis LT-92331

Lithuania

Glenmark Investigational Site 703

Vilnius, Vilniaus Apskritis LT-06326

Lithuania

Glenmark Investigational Site 707

Vilnius, Vilniaus Apskritis LT-08411

Lithuania

Glenmark Investigational Site 704

Vilnius, Vilniaus Apskritis LT-08465

Lithuania

Glenmark Investigational Site 705

Vilnius, 6256

Lithuania

Glenmark Investigational Site 708

Vilnius, LT-08661

Lithuania

Glenmark Investigational Site 504

Wroclaw, Dolnoslaskie 51-124

Poland

Jolanta Weglowska, MD

jolaweglowska@tlen.pl

Glenmark Investigational Site 511

Krakow, Malopolskie 31-002

Poland

Dorota Kolodziejczyk

KAROLINA.SZCZEPANIK@NEUCA.PL

Glenmark Investigational Site 510

Krakow, Malopolskie 31-011

Poland

Maria Ignacak - Popiel

mai_@onet.eu

Glenmark Investigational Site 502

Kraków, Malopolskie 30-033

Poland

Grazyna Pulka, MD

pulkaallmed@gmail.com

Glenmark Investigational Site 501

Kraków, Malopolskie 31-209

Poland

Barbara Rewerska, MD

barbara@diamondclinic.eu

Glenmark Investigational Site 515

Warszawa, Mazowieckie 01-192

Poland

Glenmark Investigational Site 509

Warszawa, Mazowieckie 01-817

Poland

Glenmark Investigational Site 521

Warszawa, Mazowieckie 02-625

Poland

Slowinska Monika, MD

monika.slowinska@yahoo.com

Glenmark Investigational Site 512

Warszawa, Mazowieckie 02-758

Poland

Glenmark Investigational Site 506

Warszawa, Mazowieckie 04-141

Poland

Witold Owczarek, MD

witold.owczarek@dermedicus.pl

Glenmark Investigational Site 517

Iwonicz-Zdrój, Podkarpackie 38-440

Poland

Langner Andrzej, MD

langnera13@gmail.com

Glenmark Investigational Site 519

Gdynia, Pomorskie 81-338

Poland

Szarmach Adam, MD

aszarmach@pratia.pl

Glenmark Investigational Site 520

Gdynia, Pomorskie 81-384

Poland

Slugocki Rafal, MD

rafal.slugocki@synexus.com

Glenmark Investigational Site 516

Katowice, Slaskie 40-123

Poland

Glenmark Investigational Site 518

Poznań, Wielkopolskie 60-702

Poland

Maciejewska Jolanta, MD

maciejewskajola@wp.pl

Glenmark Investigational Site 514

Poznań, Wielkopolskie 60-848

Poland

Dadej - Michalska Ingrid, MD

i.dad@wp.pl

Glenmark Investigational Site 513

Szczecin, Zachodniopomorskie 71-270

Poland

Debniak Tadeusz, MD

koteras@twojaprzychodnia.com

Glenmark Investigational Site 503

Katowice, 40-851

Poland

Marcin Zakrzewski, MD

marcinzakrzewski@poczta.fm

Glenmark Investigational Site 505

Kraków, 31-513

Poland

Glenmark Investigational Site 508

Skarzysko-Kamienna, 26-110

Poland

Glenmark Investigational Site 507

Warszawa, 02-777

Poland

Maria Zegadlo -Mylik, MD

k.jedynski@etg-network.com