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

• Status: Recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Psoriasis Treatment Center of Central New Jersey
• Collaborator: Sun Pharmaceutical Industries Limited

Criteria

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)