Recruiting

ILUMYA & HALOG

Sponsor:

Psoriasis Treatment Center of Central New Jersey

Code:

NCT04347473

Conditions

Psoriasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ilumya Injectable Product

Study Details

Brief summary:

Patient with moderate-to-severe plaque psoriasis will receive Ilumya with or without Halog ointment.

Conditions

Psoriasis

Study ID

NCT04347473

Start date

Apr 6, 2020

Status verified date

Apr, 2020

Completion date

Mar 1, 2021

Anticipated

Primary completion date

Dec 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female adult ≥ 18 years of age;
2. Diagnosis of moderate-to-severe chronic plaque-type psoriasis as defined by

  • BSA 10%
  • PGA ≥3
  • PASI ≥12
3. Must be a candidate for phototherapy and/or systemic therapy
4. Females of childbearing potential (FCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at 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.

Exclusion Criteria:

1. Non-plaque forms of psoriasis
2. Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating
3. Presence of significant uncontrolled medical condition that in the opinion of the investigator would affect patient safety during the trial.
4. Active or untreated latent tuberculosis (TB)

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ilumya

Ilumya 100mg subcutaneous at weeks 0, 4 and 16.

Interventions

Ilumya Injectable Product

IL-23 injection

Primary outcome measure

  • Body surface area [ Time Frame: 16 weeks ]

Central Contacts and Locations

Locations

Psoriasis Treatment Center of Central New Jersey

Recruiting

East Windsor, New Jersey, United States, 08520

Contacts

Principal Investigator:

Jerry Bagel, MD

More Information

Sponsor

Psoriasis Treatment Center of Central New Jersey

Last update posted

Apr 15, 2020

Last verified

Apr, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Psoriasis Treatment Center of Central New Jersey on 2020-04-15.