ILUMYA in Combination With HALOG Ointment 0.1% for Plaque Psoriasis.
Patient with moderate-to-severe plaque psoriasis will receive Ilumya with or without Halog ointment.
Conditions:
🦠 Psoriasis
🗓️ Study Start (Actual) 6 April 2020
🗓️ Primary Completion (Estimated) 30 December 2020
✅ Study Completion (Estimated) 1 March 2021
👥 Enrollment (Estimated) 25
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 East Windsor, New Jersey, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 April 2020
  • First Submitted that Met QC Criteria 13 April 2020
  • First Posted 15 April 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 April 2020
  • Last Update Posted 15 April 2020
  • Last Verified April 2020