Taltz in Combination With Enstilar for Psoriasis

Study Purpose

Enstilar in combination with Taltz for plaque psoriasis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04372277
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Psoriasis Treatment Center of Central New Jersey
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Additional Details

A single center study of 25 subjects to assess the addition of Enstilar Foam in patients receiving Taltz for ≥ 24 weeks with BSA between 3% and 8%.

Arms & Interventions

Arms

Experimental: Enstilar

Enstilar foam

Interventions

Drug: - Enstilar

topical Enstilar foam

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

East Windsor, New Jersey

Status

Recruiting

Address

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520

Site Contact

Elise Nelson

enelson@windsordermatology.com

609-443-4500

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