Moderate to Severe Plaque Type Psoriasis MedDRA version: 19.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Be a man or a woman at least 18 years of age 2.Have a diagnosis of plaque-type psoriasis for at least 6 months before the first administration of study drug. 3.Have a PASI =12 at screening and at baseline. 4.Have an IGA =3 at screening and at baseline. 5.Have an involved BSA =10% at screening and at baseline. 6. Be a candidate for phototherapy or systemic treatment for psoriasis Please refer to protocol pages 20-22 for all the inclusion criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. 2.Has unstable cardiovascular disease, defined as a recent clinical deterioration in the last 3 months or a cardiac hospitalization within the last 3 months. 3.Currently has a malignancy or has a history of malignancy within 5 years before screening 4.Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly. 5.Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection, recurrent urinary tract infection, fungal infection, or open, draining, or infected skin wounds or ulcers. 6. Tests positive for hepatitis B virus (HBV) infection or is seropositive for antibodies to hepatitis C virus (HCV) at screening; unless they have 2 negative HCV RNA test results 6 months apart after completing antiviral treatment and prior to screening, and have a third negative HCV RNA test result at screening. 7. Has unstable suicidal ideation or suicidal behavior, that may be defined as an eCSSRS rating at screening of: Suicidal ideation with intention to act, Suicidal ideation with specific plan and intent or a suicide attempt in the last 6 months and is confirmed to be at risk by the investigator based on an evaluation by a mental health professional. The final decision on excluding a subject will be made at the judgment of the investigator. Please refer to protocol pages 23-26 for all the exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of guselkumab delivered using the SelfDose device for the treatment of subjects with moderate to severe plaque-type psoriasis. • To assess the safety and tolerability of guselkumab delivered using the SelfDose device in subjects with moderate to severe plaque-type psoriasis. ;Secondary Objective: • To assess the pharmacokinetics (PK) and immunogenicity of guselkumab following subcutaneous administration using the SelfDose device in subjects with moderate to severe plaque-type psoriasis. • To assess usability and acceptability of the SelfDose device. ;Primary end point(s): Co-primary end points: • The proportion of subjects who achieve an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal (1) at Week 16. • The proportion of subjects who achieve a PASI 90 response at Week 16. ;Timepoint(s) of evaluation of this end point: week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Major Secondary Endpoints • The proportion of subjects who achieve an IGA score of cleared (0) at Week 16. • The proportion of subjects who achieve a PASI 100 response at Week 16. Other Secondary Endpoints • The proportion of subjects achieving an IGA score of mild or better (=2) at Week 16. • The proportion of subjects who achieve a PASI 75 response and a PASI 50 response at Week 16. • The percent improvement from baseline in PASI response at Week 16. • The proportion of subjects with successful, problem-free injections (assessment of usability) at Week 0. • Self-Injection Assessment Questionnaire (SIAQ) domain scores on the 3 domains with items common to the SIAQ PRE- (Week 0) and POST- (Week 0 and Week 12) self-injection modules. • SIAQ POST-self-injection domain scores and change from baseline scores for each domain at Weeks 0, 4, 12, and 28. • The proportion of subjects who had full delivery of the dose confirmed by inspection of the device at Weeks 4 and 12. ;Timepoint(s) of evaluation of this end point: Week 16, 0, 12, 4 and 28 | — |
Countries
Canada, Poland, United States
Contacts
Public ContactClinical Registry group
Janssen-Cilag International NV
Outcome results
None listed