ILUMYA in Combination With HALOG Ointment 0.1% for Plaque Psoriasis.

Last updated: April 13, 2020
Sponsor: Psoriasis Treatment Center of Central New Jersey
Overall Status: Active - Recruiting

Phase

4

Condition

Skin Wounds

Rash

Warts

Treatment

N/A

Clinical Study ID

NCT04347473
PTC08
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

  1. Must be a candidate for phototherapy and/or systemic therapy

  2. Females of childbearing potential (FCBP) must have a negative serum pregnancy test atScreening and negative urine pregnancy test at Baseline. FCBP who engage in activityin which conception is possible must use one of the approved contraceptive options:hormonal contraception; intrauterine device (IUD); tubal ligation; or partner'svasectomy; Male or female condom diaphragm with spermicide, cervical cap withspermicide, or contraceptive sponge with spermicide.

Exclusion

Exclusion Criteria:

  1. Non-plaque forms of psoriasis

  2. Women of childbearing potential who are pregnant, intend to become pregnant, or arelactating

  3. Presence of significant uncontrolled medical condition that in the opinion of theinvestigator would affect patient safety during the trial.

  4. Active or untreated latent tuberculosis (TB)

Study Design

Total Participants: 25
Study Start date:
April 06, 2020
Estimated Completion Date:
March 01, 2021

Study Description

25 adult subjects with moderate to severe plaque psoriasis will receive Ilumya 100mg subcutaneously at weeks 0, 4 and 16.

At week 16, patients with remaining BSA ˃3% will be given HALOG ointment 0.1% to apply BID for 4 weeks. Patients who have ≤3% BSA at week 16 will remain on Ilumya monotherapy.

Patients will continue to be evaluated at weeks 20 and 24.

Connect with a study center

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey 08520
    United States

    Active - Recruiting

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