PsoriasisPhase 4NCT04347473
ILUMYA in Combination With HALOG Ointment 0.1% for Plaque Psoriasis.
A Phase 4 study testing Ilumya Injectable Product in people with Psoriasis, run by Psoriasis Treatment Center of Central New Jersey at 1 site in United States.
Trial summary
Patient with moderate-to-severe plaque psoriasis will receive Ilumya with or without Halog ointment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Ilumya Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2020to 1 Mar 2021
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
Elise Nelson, 609-443-4500 ext. 1402, enelson@windsordermatology.com
Jerry Bagel, MD
About this study
Official title: A Single Center Study to Evaluate the Effectiveness and Safety of ILUMYA in Combination With HALOG Ointment 0.1% for the Treatment of Moderate to Severe Plaque Psoriasis.
Patient with moderate-to-severe plaque psoriasis will receive Ilumya with or without Halog ointment.
Read the 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% 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.
- Conditions
- Psoriasis
- Being tested
- Ilumya Injectable Product
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ilumya Injectable ProductDrug
IL-23 injection
| Study group | Role | What they receive |
|---|---|---|
| Ilumya | Experimental | Ilumya 100mg subcutaneous at weeks 0, 4 and 16. Receives: Drug: Ilumya Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body surface area
evaluation of body surface area percentage affected by psoriasis where 1 palm is equivalent to 1%
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start6 Apr 2020
- Primary completion30 Dec 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open label
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psoriasis Treatment Center of Central New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Pharmaceutical Industries Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347473
- Sponsor's protocol ID
- PTC08
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No