NCT04876391 - A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 24, 2021

Primary Completion Date

April 26, 2024

Study Completion Date

April 26, 2024

Conditions

Hidradenitis Suppurativa

Interventions

DRUG

Spesolimab 1200 mg

Participants in the 1368-0052 PoCC trial's placebo arm received a 1200 mg intravenous (i.v.) loading dose at Visit 1, then 600 mg s.c. every two weeks for 12 weeks.

DRUG

Spesolimab 600 mg

Participants in the 1368-0052 PoCC trial's active arm received a 600 mg subcutaneous (s.c.) loading dose of spesolimab at Visit 1, followed by 600 mg s.c. every two weeks for 12 weeks.

DRUG

Placebo matching 600 mg Spesolimab

Participants from the placebo arm of the 1368-0052 PoCC trial will receive a subcutaneous (s.c.) administration of placebo matching 600 mg spesolimab at Visit 1.

DRUG

Placebo matching 1200 mg Spesolimab

Participants from the active arm of the 1368-0052 PoCC trial will receive an intravenous (i.v.) infusion of placebo matching 1200 mg spesolimab at Visit 1

Trial Locations (27)

1200

Cliniques Universitaires Saint-Luc, Brussels

2010

Holdsworth House Medical Practice, Sydney

3050

Royal Melbourne Hospital, Parkville

28006

Hospital La Princesa, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

31059

HOP Larrey, Toulouse

33624

Forward Clinical Trials, Tampa

42624

Non-Public Health Care Facility LABDERM, Ossy

44791

Katholisches Klinikum Bochum gGmbH, Bochum

46250

Dawes Fretzin Clinical Research Group, LLC-Indianapolis-58713, Indianapolis

51430

CLI Reims Bezannes, Bezannes

55905

Mayo Clinic, Rochester, Rochester

56126

Azienda Ospedaliera Universitaria Pisana, Pisa

60123

Ospedali Riuniti di Ancona, Ancona

60596

Universitätsklinikum Frankfurt, Frankfurt am Main

69437

HOP Edouard Herriot, Lyon

73118

Unity Clinical Research, Oklahoma City

90045

Dermatology Research Associates, Los Angeles

L3Y 5G8

Dr. S. K. Siddha Medicine Professional Corporation, Newmarket

708 52

University Hospital Ostrava, Ostrava

06847

Städtisches Klinikum Dessau, Dessau

3015 GD

Erasmus Medisch Centrum-ROTTERDAM-50697, Rotterdam

N-5021

Haukeland Universitetssykehus, Bergen

N-8092

Nordlandssykehuset HF, Bodø, Bodø

N-0372

Oslo Universitetssykehus HF, Rikshospitalet, Oslo

50-566

Cityclinic Medical and Psychological Clinic Matusiak Partnership, Wroclaw

08026

Hospital Santa Creu i Sant Pau, Barcelona