Moderate to Severe Plaque-Type Psoriasis MedDRA version: 20.0 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 7. Be considered, in the opinion of the investigator, suitable candidates for secukinumab (Cosentyx) therapy according to their country's approved secukinumab product labeling. Reproduction-related inclusion criteria: 8. Before the first administration of study drug, a woman must be either: - Not of childbearing potential: premenarchal; postmenopausal; permanently sterilized or otherwise be incapable of pregnancy. - Of childbearing potential and practicing a highly effective method of birth control, consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies 9. A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections. 10. A woman must agree not to donate eggs for the purposes of assisted reproduction during the study and for at least 20 weeks after receiving the last administration of secukinumab or at least 12 weeks after receiving the last administration of guselkumab. 11. A man who is sexually active with a woman of childbearing potential and who has not had a vasectomy must agree to use a barrier method of birth control or a partner with an occlusive cap during the study and for at least 20 weeks after receiving the last administration of secukinumab or at least 12 weeks after receiving the last administration of guselkumab. All men must also agree to not donate sperm during the study and for at least 20 weeks after receiving the last administration of secukinumab or at least 12 weeks after receiving the last administration of guselkumab. Infectious disease-related inclusion criteria: 12. Are considered eligible according to the following TB screening criteria: - Have no history of latent or active TB before screening. o An exception is made for subjects who have a history of latent TB and - are currently receiving treatment for latent TB, - will initiate treatment for latent TB before the first administration of study drug, - or have documentation of having completed appropriate treatment for latent TB within 5 years before the first administration of study drug. o It is the responsibility of the investigator to verify the adequacy of previous anti-TB treatment and provide appropriate documentation. - Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination. - Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB before the first administration of study drug. - Within 2 months before the first administration of study drug, have a negative QuantiFERON®-TB Gold test result, or have a newly identified positive QuantiFERON-TB Gold test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated before the first administration of study drug. Within 2 months before the
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. Has unstable suicidal ideation or suicidal behavior, that may be defined as an eC-SSRS rating at screening of: Suicidal ideation with intention to act (“4”), Suicidal ideation with specific plan and intent (“5”), 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. 4. Has a transplanted organ (with exception of a corneal transplant >3 months before the first administration of study drug). 5. Has a 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. 6. Is pregnant, nursing, or planning a pregnancy (both men and women) while enrolled in this study, and for at least 20 weeks after the last administration of secukinumab or at least 12 weeks after receiving the last administration of guselkumab. 7. Has a nonplaque form of psoriasis7. Has a nonplaque form of psoriasis 8. Has current drug-induced psoriasis 9. Has had major surgery within 8 weeks before screening, or will not have fully recovered from such surgery, or has such surgery planned during the time the subject is expected to participate in the study. 10. Is known to have had a substance abuse (drug or alcohol) problem within the previous 12 months. 11. Had a known allergy or sensitivity to products containing latex. Please refer to protocol pages 27-30 for all the exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of guselkumab compared with secukinumab for the treatment of subjects with moderate to severe plaque-type psoriasis.;Secondary Objective: - The safety and tolerability of guselkumab in subjects with moderate to severe plaque-type psoriasis. - The PK and immunogenicity of guselkumab after subcutaneous (SC) administrations in subjects with moderate to severe plaque-type psoriasis.;Primary end point(s): The primary endpoint in this study is the proportion of subjects who achieve a PASI 90 response at Week 48, comparing the guselkumab group and the secukinumab group.;Timepoint(s) of evaluation of this end point: week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The major secondary endpoints to compare the guselkumab group and the secukinumab group are listed below and are the proportion of subjects who achieve: - A PASI 75 response at both Week 12 and Week 48. - A PASI 90 response at Week 12. - A PASI 75 response at Week 12. - A PASI 100 response at Week 48. - An IGA score of cleared (0) at Week 48.;Timepoint(s) of evaluation of this end point: Week 12 and 48 | — |
Countries
Australia, Canada, Czech Republic, France, Germany, Hungary, Poland, Spain, United States
Contacts
Public ContactClinical Registry group
Janssen-Cilag International NV
Outcome results
None listed