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Recruiting

NCT Number: NCT04372277

Taltz in Combination With Enstilar for Psoriasis

Enstilar in combination with Taltz for plaque psoriasis.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location status: Recruiting

Location contact

Alexa Hetzel, PA-C

SUB_INVESTIGATOR

Brianna Butler, PA-C

SUB_INVESTIGATOR

David Nieves, MD

SUB_INVESTIGATOR

Elise Nelson

CONTACT

[email protected]

609-443-4500

Jerry Bagel, MD

PRINCIPAL_INVESTIGATOR

Wendy Myers, MD

SUB_INVESTIGATOR

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enstilar

Drug

topical Enstilar foam

Primary outcomes

  1. Body Surface Area 0 or 1

    Time frame: 4 weeks

    Body surface area where 1 palm is equivalent to 1%. Endpoint will evaluate number of patiens who achieve body surface are 0 or 1.

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Nelson

CONTACT

[email protected]

6094434500

Jerry Bagel, MD

CONTACT

[email protected]

6094434500

Sponsors and collaborators

Lead sponsor

Psoriasis Treatment Center of Central New Jersey

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 4, 2020
Registry last updated
May 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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