IMMprint

Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement

Brief summary

Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. Palmoplantar (non-pustular) plaque psoriasis (PPPsO) represents a localized form of psoriasis in palms and soles. This study will evaluate how safe risankizumab is for the treatment of plaque psoriasis with palmoplantar involvement and to assess change in disease symptoms. Risankizumab is an approved drug for the treatment of psoriasis. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo in Period A. In Period B, all the participants will receive risankizumab. Around 168 adult participants with a moderate to severe plaque psoriasis will be enrolled in approximately 55 sites across the world. Participants will receive single subcutaneous (administered under the skin) risankizumab or placebo in period A (16 weeks). In period B (36 weeks), all participants will receive subcutaneous risankizumab once every 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Interventional study

Status:
Active, not recruiting
Conditions:
Psoriasis
Enrollment:
209 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M15-994
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

Would you like to know more about this trial?

Yes, please contact me

Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Inclusion Criteria:

- Diagnosis of chronic palmoplantar plaque psoriasis (PPPsO) (with or without psoriatic
arthritis) for at least 6 months before Baseline and a Palmoplantar Investigator's
Global Assessment (ppIGA) of moderate or severe, at Screening and Baseline.

- Must have at Screening and Baseline a plaque psoriasis (PsO) body surface area (BSA)
involvement of greater than or equal to one percent, an Static Physician's Global
Assessment (sPGA) score of moderate to severe (greater than or equal to three), a
PPASI moderate to severe (greater than or equal to eight), at least one additional PsO
plaque outside of the palms and soles.

- Must be a candidate for systemic therapy as assessed by the investigator.

- Previously had inadequately controlled disease by topicals, phototherapy and/or
systemic treatments.

Exclusion Criteria:

- History of PsO other than chronic plaque type PsO

- History of current drug-induced PsO or a drug-induced exacerbation of pre-existing
psoriasis.

- Ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could
interfere with PsO assessments.

- Evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, human
immunodeficiency virus (HIV), Active tuberculosis, Active systemic
infection/clinically important infections in the last two weeks prior to Baseline.

- Prior exposure to risankizumab.

All the cities where the clinical studies are located

Calgary - T3E 0B2
Surrey - V3R 6A7
St. John's - A1C 2H5
Newmarket - L3Y 5G8
Toronto - M4W 2N4
Montréal - H2X 2V1
Fredericton - E3B 1G9

Alberta

British Columbia

New Brunswick

Newfoundland and Labrador