Status:
RECRUITING
ILUMYA in Combination With HALOG Ointment 0.1% for Plaque Psoriasis.
Lead Sponsor:
Psoriasis Treatment Center of Central New Jersey
Collaborating Sponsors:
Sun Pharmaceutical Industries Limited
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Patient with moderate-to-severe plaque psoriasis will receive Ilumya with or without Halog ointment.
Detailed 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%...
Eligibility Criteria
Inclusion
- Male or female adult ≥ 18 years of age;
- Diagnosis of moderate-to-severe chronic plaque-type psoriasis as defined by
- BSA 10%
- PGA ≥3
- PASI ≥12
- Must be a candidate for phototherapy and/or systemic therapy
- 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
- Non-plaque forms of psoriasis
- Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating
- Presence of significant uncontrolled medical condition that in the opinion of the investigator would affect patient safety during the trial.
- Active or untreated latent tuberculosis (TB)
Key Trial Info
Start Date :
April 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04347473
Start Date
April 6 2020
End Date
March 1 2021
Last Update
April 15 2020
Active Locations (1)
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1
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States, 08520