Combination treatment of Taltz and Enstilar for psoriasis

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

This study is testing if adding Enstilar Foam to Taltz treatment can help adults with chronic plaque psoriasis feel better than using Taltz alone.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Psoriasis Treatment Center of Central New Jersey (other)
• Locations: 1 site (East Windsor, New Jersey)
• Trial ID: NCT04372277 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Enstilar Foam when added to Taltz treatment in adults with chronic plaque psoriasis. It involves a single center with 25 participants who have been on Taltz for at least 24 weeks and have a body surface area affected by psoriasis between 3% and 8%. The goal is to determine if the combination therapy improves outcomes for these patients compared to Taltz alone.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic plaque psoriasis who have been treated with Taltz for at least 24 weeks.

Not a fit: Patients with less than 3% or more than 8% body surface area affected by psoriasis or those who have not been on Taltz for the required duration may not benefit from this study.

Why it matters

Potential benefit: If successful, this combination therapy could enhance treatment outcomes for patients suffering from moderate plaque psoriasis.

How similar studies have performed: While this specific combination has not been extensively tested, similar approaches in psoriasis treatment have shown promising results in other studies.

Eligibility criteria

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.

Where this trial is running

East Windsor, New Jersey

• Psoriasis Treatment Center of Central New Jersey — East Windsor, New Jersey, United States (RECRUITING)

Study contacts

• Study coordinator: Jerry Bagel, MD

Conditions: Psoriasis