NCT04372277RecruitingPhase 4
Taltz in Combination With Enstilar for Psoriasis
Open Label Study, Evaluating Taltz in Combination With Enstilar (Calcipotriene and Betamethasone Dipropionate) Foam in Psoriasis Patients
Source: ClinicalTrials.gov · Last updated 4 May 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Enstilar in combination with Taltz for plaque psoriasis.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 29 Apr 2020
- Start date
- 28 Apr 2020
- Primary completion date
- 1 Mar 2021
- Lead sponsor
- Psoriasis Treatment Center of Central New Jersey
- Diseases
- Psoriasis
- NCT number
- NCT04372277
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 25
- From 28 Apr 2020 to the primary completion date, 1 Mar 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient not receiving Taltz, or receiving Taltz \<24 weeks
- 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.
Other illness
- Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
- Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label.
Other
- -˂3% or \>8% BSA
- Pregnant or breast feeding, or considering becoming pregnant during the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Psoriasis Treatment Center of Central New Jersey Coordinator of this site? Confirm its status | East Windsor | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.