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RECRUITINGPhase 4INTERVENTIONAL

Taltz in Combination With Enstilar for Psoriasis

Open Label Study, Evaluating Taltz in Combination With Enstilar (Calcipotriene and Betamethasone Dipropionate) Foam in Psoriasis Patients

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Enstilar in combination with Taltz for plaque psoriasis.

Who May Be Eligible (Plain English)

Who May Qualify: - Male or female adult ≥ 18 years of age; - Diagnosis of chronic plaque-type - Body Surface Area between 3%-8%. - Patient has been treated with Taltz for a minimum of 24 weeks - Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide. - Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination - Able and willing to give written willing to sign a consent form prior to performance of any study-related procedures. Exclusion Criteria -˂3% or \>8% BSA - Patient not receiving Taltz, or receiving Taltz \<24 weeks - Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study. - Pregnant or breast feeding, or considering becoming pregnant during the study. - Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer). - Use of oral systemic medications for the treatment of psoriasis within 4 weeks. - Patient used other topical therapies to treat within 2 weeks of the Baseline Visit. - Patient received UVB phototherapy within 2 weeks of Baseline. - Patient received PUVA phototherapy within 4 weeks of Baseline. - Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Male or female adult ≥ 18 years of age; * Diagnosis of chronic plaque-type * Body Surface Area between 3%-8%. * Patient has been treated with Taltz for a minimum of 24 weeks * Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide. * Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination * Able and willing to give written informed consent prior to performance of any study-related procedures. Exclusion Criteria -˂3% or \>8% BSA * Patient not receiving Taltz, or receiving Taltz \<24 weeks * Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study. * Pregnant or breast feeding, or considering becoming pregnant during the study. * Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer). * Use of oral systemic medications for the treatment of psoriasis within 4 weeks. * Patient used other topical therapies to treat within 2 weeks of the Baseline Visit. * Patient received UVB phototherapy within 2 weeks of Baseline. * Patient received PUVA phototherapy within 4 weeks of Baseline. * Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label.

Treatments Being Tested

DRUG

Enstilar

topical Enstilar foam

Locations (1)

Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States