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PsoriasisPhase 4PSORIASI_RISANCT04722640

Exploring the Effects of IL-23 Inhibition by Risankizumab on Psoriasis Autoimmunity

A Phase 4 study testing SKYRIZI in people with Psoriasis, run by Istituto Clinico Humanitas.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Approximately 80 patients affected by moderate to severe psoriasis will be screened for the presence of LL37( and ADAMTSL5 autoreactive T-cells in their blood at Day 0. Patients whose lymphocytes reacted with proliferation to LL37 or ADAMTSL5 will receive SKYRIZI (Risakizumab) at Day 1, week 4, 16, 28, 40. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Psoriasis
What is being tested?
SKYRIZI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
No sites listed yet
Study dates
25 Jan 2021to 31 Jan 2022
Phase
Phase 4
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has provided informed consent
  • Subject is > 18 and < 75 years of age at time of screening
  • Subject has had stable moderate to severe plaque psoriasis for at least 6 months (e.g., no morphology changes or significant flares of disease activity in the opinion of the Investigator)
  • Subject has involved body surface area (BSA) > 10% and PASI > 12 at baseline
  • Subject candidates to SKYRIZI therapy according to local label
  • Subject is able to complete study procedures, including self-assessments and self injections
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  • Subjects who responded with T-lymphocytes proliferation to the psoriasis autoantigen LL37 or ADAMTSL5.
  • Subject is male or a woman not of child-bearing potential, including:
  • infertile patients due to surgical sterilization, congenital anomalies
  • OR postmenopausal, defined as: a woman of at least 50 years of age with an intact uterus, not on hormone therapy, who has either:
  • Cessation of menses for at least 1 year
  • OR At least 6 months of spontaneous amenorrhea with a follicle stimulating hormone level of >40 mIU/mL
  • OR A woman of 55 years or older not on hormone therapy who has had at least 6 months of spontaneous amenorrhea
  • OR A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy
  • Subject is a woman of child-bearing potential and:
  • Must test negative for pregnancy prior to first dose in Study
  • Must agree to either remain abstinent, if complete abstinence is their preferred and usual lifestyle, or remain in same-sex relationships, if part of their preferred and usual lifestyle, or without sexual relationships with males. Periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable methods of contraception.
  • OR Must use 2 effective methods of contraception for the entirety of the study. Abstinence or contraception must continue for 21 weeks following completion of investigational product administration
  • Two effective methods of contraception (such as male or female condoms with spermicide, diaphragms with spermicide or cervical sponges) will be used. The patient may choose to use a doublebarreled method of contraception. Barrier protection methods without concomitant use of a spermicide are not a reliable or acceptable method. Thus, each barrier method must include use of a spermicide. It should be noted that the use of male and female condoms as a double-barrier method is not considered acceptable due to the high failure rate when these methods are combined.
  • Of note, 1 of the 2 methods of contraception may be a highly effective (less than 1% failure rate) method of contraception (such as, combination oral contraceptives, implanted contraceptives or intrauterine devices).

Who cannot join

  • Skin disease related:
  • Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis
  • Other medical conditions:
  • Subject has a planned surgical intervention during the duration of the study
  • Subject has a known history of human immunodeficiency virus
  • Hepatitis B surface antigen or Hepatitis C antibody positivity at screening
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  • Patient is hepatitis B core antibody positive (HBcAb+) but HbsAg and HBsAb negative
  • Subject has uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease, renal failure, liver disease, or hypertension
  • Subject has any active malignancy, including evidence of cutaneous basal orsquamous cell carcinoma or melanoma
  • Subject has history of malignancy within 5 years except treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma
  • Subject has any concurrent medical condition that, in the opinion of the Investigator, could cause this study to be detrimental to the subject
  • Has active TB or other serious infection
  • Has received, or is expected to receive, any live virus or bacterial vaccination within 4 weeks before the first administration of study intervention
  • Laboratory abnormalities:
  • Laboratory abnormalities at screening, including any of the following:
  • Hemoglobin < 9 g/dL
  • Platelet count < 100,000/mm3
  • White blood cell count < 3,000 cells/mm3
  • Absolute neutrophil count (ANC) < 1000/mm3
  • Creatinine clearance < 50 mL/min (Cockcroft-Gault formula)
  • Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results
  • Washouts and non-permitted drugs:
  • Has received prior treatment with IL-12/23 inhibitor or IL23 inhibitor. Has received any with other biological agents for psoriasis without proper washout period of 4 weeks.
  • Subject has used UV B therapy within 14 days before first dose of investigational product
  • Subject has used topical therapy for psoriasis as follows:
  • superpotent (class I) or potent (class II) topical steroids or topical anthralin within 14 days before first dose of investigational product
  • any other formulation or potency of topical therapy or UV B phototherapy within 14 days before first dose of investigational product (exception: upper mid-strength to least potent [class III to VII] topical steroids permitted on the palms, soles, face and intertriginous areas)
  • Subject has used the following within 28 days of first dose of investigational product:
  • UVA light therapy (with or without psoralen) or excimer laser;
  • non-biologic systemic therapy for psoriasis (including but not limited to oral retinoids, cyclosporine, systemically administered calcineurin inhibitors, azathioprine, thioguanine, hydroxyurea, fumarates, or oral or parenteral corticosteroids including intramuscular or intraarticular administration [exception: optic, nasal, or inhaled corticosteroids within recommended doses is permitted])
  • Subject currently is enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) General
  • Active substance abuse (within 24 weeks of screening)
  • Has known intolerance or hypersensitivity to Risakizumab, or known allergies or clinically significant reactions.

Trial locations and contacts

No sites are listed yet.

Antonio Costanzo, MD contact

0039-02-82244050

antonio.costanzo@hunimed.eu

About this study

Approximately 80 patients affected by moderate to severe psoriasis will be screened for the presence of LL37( and ADAMTSL5 autoreactive T-cells in their blood at Day 0. Patients whose lymphocytes reacted with proliferation to LL37 or ADAMTSL5 will receive SKYRIZI (Risakizumab) at Day 1, week 4, 16, 28, 40. LL37 and ADAMTSL5-specific T-cell responses will be evaluated at Day 0, week 16, week 28 and week 52. Each patient will be followed for 52 weeks.

Conditions
Psoriasis
Being tested
SKYRIZI
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SKYRIZIDrug

    SKYRIZI

Study groups in NCT04722640
Study groupRoleWhat they receive
RISAKIZUMABExperimentalSKYRIZI
Receives: Drug: SKYRIZI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of activated autoantigen-specific T-cells

    Proportion of activated autoantigen-specific T-cells as measured by LL37 and ADAMTSL5 antigens by antigenic-specific proliferation assay at 28 weeks with respect to baseline.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2021
  2. Study start25 Jan 2021 (estimated)
  3. Primary completion31 Jan 2022 (estimated)
  4. Study completion31 Jan 2022 (estimated)

Resources

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
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04722640
Sponsor's protocol ID
2763
Acronym
PSORIASI_RISA
Status last verified
Jan 2021
First submitted
20 Jan 2021
Last updated
29 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing SKYRIZI in people with Psoriasis, run by Istituto Clinico Humanitas.

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 20 inclusion and 33 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: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Antonio Costanzo, MD (0039-02-82244050, antonio.costanzo@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of activated autoantigen-specific T-cells (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04722640.

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 29 Jan 2021.

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