Taltz in Combination With Enstilar for Psoriasis

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04372277
• Other study ID #: PTC06
• Status: Recruiting
• Phase: Phase 4
• Start date: April 28, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: April 2020
• Source: Psoriasis Treatment Center of Central New Jersey
• Contact: Jerry Bagel, MD
• Phone: 6094434500
• Email: dreamacres1[@]aol.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Enstilar in combination with Taltz for plaque psoriasis.

Description:

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 30, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Enstilar
topical Enstilar foam

Locations

Country	Name	City	State
United States	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Psoriasis Treatment Center of Central New Jersey	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Surface Area 0 or 1	Body surface area where 1 palm is equivalent to 1%. Endpoint will evaluate number of patiens who achieve body surface are 0 or 1.	4 weeks