PsoriasisPhase 3IMMPRESSNCT03518047
Risankizumab Therapy Versus Placebo for Subjects With Psoriasis in the Russian Federation
A Phase 3 study testing risankizumab in people with Psoriasis, run by AbbVie at 6 sites in Russia.
Trial summary
The purpose of this study is to assess the safety and efficacy of risankizumab compared to placebo in subjects with moderate to severe chronic plaque psoriasis in the Russian Federation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- risankizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 6 sitesRussia
- Study dates
- 19 Jul 2018to 11 Feb 2020
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.
- Moderate to severe chronic plaque psoriasis at both Screening and Baseline (Randomization) Visits
- Candidates for systemic therapy or phototherapy for psoriasis treatment as assessed by the investigator
Who cannot join
- Prior therapy with an anti-interleukin (IL)-17 or anti-IL12/23p40 or anti-IL-23p19 inhibitor
- Concurrent therapy with a biologic and/or other systemic therapy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
Alliance Biomedical Ural Group /ID# 201681
Izhevsk, Udmurtiya Republic, 426061
Family Outpatient clinic#4 LLC /ID# 207441
Korolev, Moscow, 141060
GBUZ Clinical Dermatovenerology Dispensary of MoH of Krasnodar region /ID# 201713
Krasnodar, Krasnodarskiy Kray, 350020
SBHI KVD # 10 Clinic of Dermatology and venerology /ID# 200615
Saint Petersburg, Sankt-Peterburg, 194021
LLC ArsVitae Severo-Zapad /ID# 200658
Saint Petersburg, Sankt-Peterburg, 194223
LLC Kurator /ID# 200616
Saint Petersburg, Sankt-Peterburg, 196240
About this study
Official title: Risankizumab Versus Placebo in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment in the Russian Federation (IMMpress)
The purpose of this study is to assess the safety and efficacy of risankizumab compared to placebo in subjects with moderate to severe chronic plaque psoriasis in the Russian Federation.
- Conditions
- Psoriasis
- Being tested
- risankizumab, placebo for rizankizumab
- Keywords
- Plaque Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risankizumabDrug
Also called ABBV-066, BI 655066
rizankizumab subcutaneous (SC) infusion
placebo for rizankizumabDrug
placebo for rizankizumab subcutaneous (SC) infusion
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo for risankizumab by subcutaneous (SC) injection. Receives: Drug: placebo for rizankizumab |
| Risankizumab | Experimental | Risankizumab by subcutaneous (SC) injection. Receives: Drug: risankizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
The PASI score is an established measure of clinical efficacy for psoriasis medications.
Measured: Week 16
Secondary outcomes (4)
Proportion of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 16
The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Measured: Week 16
Proportion of participants with a 75% reduction from Baseline Psoriasis Area and Severity Index (PASI 75) at Week 16
The PASI score is an established measure of clinical efficacy for psoriasis medications.
Measured: Week 16
Proportion of participants with a 100% reduction from Baseline Psoriasis Area and Severity Index (PASI 100) at Week 16
The PASI score is an established measure of clinical efficacy for psoriasis medications.
Measured: Week 16
Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status. Scores range from 0 (not relevant/not at all) to 3 (very much).
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start19 Jul 2018
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518047
- Sponsor's protocol ID
- M16-176
- Acronym
- IMMPRESS
- Status last verified
- Jan 2021
- First submitted
- 4 May 2018
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 and 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.
Publications
Odnopozova L, Edin A, Sukharev A, Wu T, Aydin K, Kelly M, Khotko A. Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation. Dermatol Ther (Heidelb). 2022 Sep;12(9):2063-2075. doi: 10.1007/s13555-022-00776-0. Epub 2022 Aug 2.
PubMed 35917057
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risankizumab Versus Placebo in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment in the Russian Federation (IMMpress)
- ClinicalTrials.gov ID
- NCT03518047
- Acronym / sponsor ID
- IMMPRESS / M16-176
- Conditions
- Psoriasis
- Keywords
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 8 May 2018 (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.
The purpose of this study is to assess the safety and efficacy of risankizumab compared to placebo in subjects with moderate to severe chronic plaque psoriasis in the Russian Federation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placebo for rizankizumabPlacebo for risankizumab by subcutaneous (SC) injection. |
| Risankizumab | Experimental | Drug: risankizumabRisankizumab by subcutaneous (SC) injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.
- Moderate to severe chronic plaque psoriasis at both Screening and Baseline (Randomization) Visits
- Candidates for systemic therapy or phototherapy for psoriasis treatment as assessed by the investigator
Key exclusion criteria (2 listed)
- Prior therapy with an anti-interleukin (IL)-17 or anti-IL12/23p40 or anti-IL-23p19 inhibitor
- Concurrent therapy with a biologic and/or other systemic therapy
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 |
|---|---|---|
| risankizumabAlso: ABBV-066, BI 655066rizankizumab subcutaneous (SC) infusion | Drug | Risankizumab |
| placebo for rizankizumabplacebo for rizankizumab subcutaneous (SC) infusion | Drug | Placebo |
Primary outcome
Proportion of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
Time frame: Week 16
The PASI score is an established measure of clinical efficacy for psoriasis medications.
4 secondary outcomes
Proportion of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 16
Time frame: Week 16
Proportion of participants with a 75% reduction from Baseline Psoriasis Area and Severity Index (PASI 75) at Week 16
Time frame: Week 16
Proportion of participants with a 100% reduction from Baseline Psoriasis Area and Severity Index (PASI 100) at Week 16
Time frame: Week 16
Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
Time frame: Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Derived from this study: PubMed 35917057Odnopozova L, Edin A, Sukharev A, Wu T, Aydin K, Kelly M, Khotko A. Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation. Dermatol Ther (Heidelb). 2022 Sep;12(9):2063-2075. doi: 10.1007/s13555-022-00776-0. Epub 2022 Aug 2.
- Individual participant dataSharing planned: Yes. 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 and 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.
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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. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing risankizumab in people with Psoriasis, run by AbbVie at 6 sites in Russia.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16 (time frame: Week 16). 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 NCT03518047, which also lists 1 linked publication.
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 25 Jan 2021.