Psoriasis Clinical Trial

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

Summary

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

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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)

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

25

Study ID:

NCT04347473

Recruitment Status:

Unknown status

Sponsor:

Psoriasis Treatment Center of Central New Jersey

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There is 1 Location for this study

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Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States More Info
Elise Nelson
Contact
609-443-4500
[email protected]
Jerry Bagel, MD
Principal Investigator
David Nieves, MD
Sub-Investigator
Alexa Hetzel, PA-C
Sub-Investigator
Brianna Butler, PA-C
Sub-Investigator
Wendy Myers, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

25

Study ID:

NCT04347473

Recruitment Status:

Unknown status

Sponsor:


Psoriasis Treatment Center of Central New Jersey

How clear is this clinincal trial information?

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