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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04347473
- Acronym / sponsor ID
- PTC08
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Psoriasis Treatment Center of Central New JerseyUniversity, hospital or other
- Collaborators
- Sun Pharmaceutical Industries Limited
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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% 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open label
| Arm | Type | Receives |
|---|---|---|
| Ilumya | Experimental | Drug: Ilumya Injectable ProductIlumya 100mg subcutaneous at weeks 0, 4 and 16. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female adult ≥ 18 years of age;
- Diagnosis of moderate-to-severe chronic plaque-type psoriasis as defined by
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ilumya Injectable ProductIL-23 injection | Drug | Ilumya |
Primary outcome
Body surface area
Time frame: 16 weeks
evaluation of body surface area percentage affected by psoriasis where 1 palm is equivalent to 1%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jerry Bagel, MD (6094434500, dreamacres1@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body surface area (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020; AzTrials last refreshed its copy on 26 Oct 2026.