A clinical study comparing different doses of a potential new medicine with an inactive medicine for patients with moderate to severe psoriasis
Key facts
- Where
- Berlin, Bonn, Bramsche, Erlangen, Kiel, Langenau, Luebeck, Osnabrueck, Schwerin és Tuebingen, NémetországSee the 10 sites
- Phase
- 2. fázis
Where in Németország
- ISA - Interdisciplinary Study Association GmbHBerlin, NémetországNo longer taking part
- Universitaetsklinikum Bonn AöRBonn, NémetországNo longer taking part
- Studienzentrum an der Hase GbRBramsche, NémetországNo longer taking part
- Universitaetsklinikum Erlangen AöRErlangen, NémetországNo longer taking part
- Universitaetsklinikum Schleswig-Holstein AöRKiel, NémetországNo longer taking part
- Studienzentrum Dr. SchwarzLangenau, NémetországNo longer taking part
- Universitaetsklinikum Schleswig-Holstein AöRLuebeck, NémetországNo longer taking part
- Klinische Forschung OsnabrueckOsnabrueck, NémetországNo longer taking part
- Klinische Forschung Schwerin GmbHSchwerin, NémetországNo longer taking part
- Universitaetsklinikum Tuebingen AöRTuebingen, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Cilag International
- Trial code
- EU 2023-508992-35-00
- Record updated
- 2024. május 13.
- Original description
To evaluate the efficacy of JNJ-81241459 compared with placebo in participants with moderate to severe plaque psoriasisRead full original descriptionShow less
A Phase 2b Multicenter, Randomized, Double-blind, Placebo-controlled Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-81241459 for the Treatment of Participants with Moderate to Severe Plaque Psoriasis
To evaluate the efficacy of JNJ-81241459 compared with placebo in participants with moderate to severe plaque psoriasis
Inclusion: Be ≥18 (or the legal age of consent if it is higher in the jurisdiction in which the study is taking place) years of age at screening, inclusive; Diagnosis of plaque psoriasis; Total BSA ≥10% at screening and baseline; Total PASI ≥12 at screening and baseline; Total IGA ≥3 at screening and baseline.
Exclusion: A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances; A current diagnosis or history of IBD; Known allergies, hypersensitivity, or intolerance to JNJ-81241459 or its excipients (refer to the JNJ-81241459 IB); Current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium); Nonplaque form of psoriasis (eg, erythrodermic, guttate, or pustular).