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 (IMMprint)
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| ClinicalTrials.gov Identifier: NCT04713592 |
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Recruitment Status :
Completed
First Posted : January 19, 2021
Last Update Posted : May 23, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Psoriasis | Drug: Risankizumab Drug: Placebo for Risankizumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 174 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | IMMprint: A Phase 3b Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study Evaluating Safety and Efficacy of Risankizumab Compared to Placebo in Adult Subjects With Moderate to Severe Plaque Psoriasis With Palmoplantar (Non-Pustular) Involvement (PPPsO) |
| Actual Study Start Date : | February 26, 2021 |
| Actual Primary Completion Date : | June 30, 2022 |
| Actual Study Completion Date : | April 20, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Risankizumab
Participants will receive risankizumab for 52 weeks
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Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
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Placebo Comparator: Placebo
Participants will receive placebo for 16 weeks followed by risankizumab for 36 weeks.
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Drug: Risankizumab
Subcutaneous (SC) Injection
Other Names:
Drug: Placebo for Risankizumab Subcutaneous (SC) Injection |
- Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) of "clear" or "almost clear" (0 or 1) with at least a 2 point reduction from Baseline [ Time Frame: Baseline (Week 0) through Week 16 ]The ppIGA is a 5 point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), and scaling of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being "clear" and 1 being "almost clear."
- Number of Participants with Adverse Events [ Time Frame: Baseline (Week 0) through 20 weeks after last dose of study drug (Up to 60 weeks total) ]Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 20 weeks after last dose of study drug.
- Percentage of Participants Achieving >= 75% improvement in Palmoplantar Psoriasis Area and Severity Index (PPASI 75) response [ Time Frame: Baseline (Week 0) through Week 16 ]PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72.
- Percentage of Participants Achieving >= 90% improvement in Palmoplantar Psoriasis Area and Severity Index (PPASI 90) response [ Time Frame: Baseline (Week 0) through Week 16 ]PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72.
- Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of "clear" or "almost clear" (0 or 1) with at least a 2 point reduction from Baseline [ Time Frame: Baseline (Week 0) through Week 16 ]sPGA is a 5 point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
- Percentage of Participants Achieving 100% improvement in Palmoplantar Psoriasis Area and Severity Index (PPASI 100) response [ Time Frame: Baseline (Week 0) through Week 16 ]PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04713592
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| Study Director: | ABBVIE INC. | AbbVie |
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT04713592 |
| Other Study ID Numbers: |
M15-994 2020-000581-42 ( EudraCT Number ) |
| First Posted: | January 19, 2021 Key Record Dates |
| Last Update Posted: | May 23, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| Time Frame: | For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/ |
| Access Criteria: | Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ |
| URL: | https://vivli.org/ourmember/abbvie/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Psoriasis Plaque Psoriasis Moderate to Severe Plaque Psoriasis Plaque Psoriasis with Palmoplantar (Non-Pustular) Involvement (PPPsO) |
Risankizumab SKYRIZI ABBV-066 |
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |