NCT04372277 Taltz in Combination With Enstilar for Psoriasis
| NCT ID | NCT04372277 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Psoriasis Treatment Center of Central New Jersey |
| Condition | Psoriasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2020-04-28 |
| Primary Completion | 2021-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 25 participants in total. It began in 2020-04-28 with a primary completion date of 2021-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Enstilar in combination with Taltz for plaque psoriasis.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04372277 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Psoriasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04372277 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04372277 currently recruiting?
Yes, NCT04372277 is actively recruiting participants. Contact the research team at dreamacres1@aol.com for enrollment information.
Where is the NCT04372277 trial being conducted?
This trial is being conducted at East Windsor, United States.
Who is sponsoring the NCT04372277 clinical trial?
NCT04372277 is sponsored by Psoriasis Treatment Center of Central New Jersey. The trial plans to enroll 25 participants.
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