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Clinical Trials/2023-508424-34-00
2023-508424-34-00CompletedPhase 3

A Phase 3b, Randomized, Double-blind, Parallel Group, Multicenter Study to Evaluate Further Therapeutic Strategies with Guselkumab in Patients with Moderate-to-Severe Plaque-Type Psoriasis

Janssen Cilag International6 sites in 1 country828 target enrollmentStarted: June 5, 2024Last updated:
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Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
828
Locations
6
Primary Endpoint
The primary endpoint of the main study is the proportion of subjects in study groups 2a and 2b who achieve an absolute PASI score <3 at week 68.
Study OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The primary objective of the study is to demonstrate that Super- Responders maintain control of disease until week 68 with prolonged treatment intervals of 16 weeks (100 mg q16w).

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Male or female with at least 18 years of age.
  • •Has a disease duration of plaque psoriasis of either ≤2 years or >2 years calculated from date at which first symptoms [plaque] were reported by subject to date of screening visit at screening; approximately 40% subjects must have a disease duration ≤2 years.
  • •Has moderate-to-severe plaque-psoriasis defined by a) a PASI score >10 or affected BSA >10% and b) a DLQI score >10 at baseline (week 0).
  • •Is a candidate for systemic treatment for psoriasis.
  • •Before first administration of study drug, a woman must be: a. Not of childbearing potential b. Of childbearing potential and practicing a highly effective method of contraception

Exclusion Criteria

  • •clinical active psoriasis arthritis which needs systemic therapy beyond NSAIDs
  • •diagnosed or reported history or current signs or symptoms indicating severe, progressive, or uncontrolled hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, which are detected at screening assessments
  • •unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months, diagnosed or reported by the subject
  • •Has a transplanted organ
  • •history of an infected joint prosthesis or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced

Outcomes

Primary Outcomes

The primary endpoint of the main study is the proportion of subjects in study groups 2a and 2b who achieve an absolute PASI score <3 at week 68.

The primary endpoint of the main study is the proportion of subjects in study groups 2a and 2b who achieve an absolute PASI score <3 at week 68.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

CTIS Point of Contact

Scientific

Janssen Cilag International

Study Sites (6)

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