PsoriasisPhase 3NCT03875482
A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing Risankizumab in people with Psoriasis, run by AbbVie at 43 sites in 2 countries.
Trial summary
The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis. 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
- 157 participants
- Where
- 43 sitesin 2 countries
- Study dates
- 13 May 2019to 15 Jul 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit.
- Participant meets following disease activity criteria:
- Stable moderate to severe chronic plaque psoriasis, defined as greater than or equal to 10% body surface area (BSA) psoriasis involvement, static physician global assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity Index (PASI) greater than or equal to 12 at Screening and baseline visit.
- Candidate for systemic therapy as assessed by the investigator.
Who cannot join
- Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis.
- Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
- Participant has previous exposure to risankizumab.
Trial locations and contacts
43 sites in 2 countries.
43 sites in 2 countries
United States40 sites
Anaheim Clinical Trials LLC /ID# 212559
Anaheim, California, 92801-2658
David Fivenson, MD, PLC /ID# 210193
Ann Arbor, Michigan, 48103
Arlington Research Center, Inc /ID# 210344
Arlington, Texas, 76011
Wallace Medical Group, Inc. /ID# 210403
Beverly Hills, California, 90211
Total Skin and Beauty Derm Ctr /ID# 210366
Birmingham, Alabama, 35205
Skin Care Research, LLC /ID# 210514
Boca Raton, Florida, 33486-2269
Treasure Valley Dermatology /ID# 212707
Boise, Idaho, 83713-0997
Clarkston Skin Research /ID# 210197
Clarkston, Michigan, 48346
ACCEL Research Sites /ID# 212709
DeLand, Florida, 32720
Henry Ford Medical Center /ID# 211598
Detroit, Michigan, 48202-3046
Psoriasis Treatment Ctr NJ /ID# 210837
East Windsor, New Jersey, 08520
Palmetto Clinical Trial Services /ID# 210368
Fountain Inn, South Carolina, 29644-1928
Skin Laser and Surgery Specialists of NY and NJ /ID# 210208
Hackensack, New Jersey, 07601-1997
Center for Clinical Studies - Houston (Binz) /ID# 210361
Houston, Texas, 77004-8097
Clinical Partners, LLC /ID# 210642
Johnston, Rhode Island, 02919
Cleaver Dermatology /ID# 210300
Kirksville, Missouri, 63501-5362
Multi-Speciality Research Associates /ID# 211625
Lake City, Florida, 32055-8835
Dermatology Res. Assoc., CA /ID# 210402
Los Angeles, California, 90045
Forefront Dermatology /ID# 210520
Louisville, Kentucky, 40202-2862
DS Research /ID# 210272
Louisville, Kentucky, 40241-6162
GSI Clinical Research, LLC /ID# 210330
Margate, Florida, 33063
Coastal Carolina Research Ctr /ID# 213069
Mt. Pleasant, South Carolina, 29464
Suncoast Clinical Research /ID# 210874
New Port Richey, Florida, 34652
Sneeze, Wheeze, & Itch Associates, LLC /ID# 212562
Normal, Illinois, 61761
Lynn Health Science Institute (LHSI) /ID# 213216
Oklahoma City, Oklahoma, 73112
Advanced Dermatology of the Midlands /ID# 212763
Omaha, Nebraska, 68144-1105
Skin Specialists, PC /ID# 211490
Omaha, Nebraska, 68144
Ormond Medical Arts Pharmaceutical Research Center /ID# 212781
Ormond Beach, Florida, 32174-6302
Alliance Dermatology and MOHs /ID# 210645
Phoenix, Arizona, 85032
The Indiana Clinical Trials Center /ID# 210205
Plainfield, Indiana, 46168
Progressive Medical Research /ID# 210877
Port Orange, Florida, 32127
Hull Dermatology, PA /ID# 210305
Rogers, Arkansas, 72758
Integrative Skin Science and Research /ID# 212551
Sacramento, California, 95815-4500
Progressive Clinical Research /ID# 210359
San Antonio, Texas, 78229
Mosaic Dermatology /ID# 210780
Santa Monica, California, 90404
DermResearchCenter of NY, Inc. /ID# 210652
Stony Brook, New York, 11790
Acclaim Dermatology /ID# 212252
Sugar Land, Texas, 77479-2645
Precision Clinical Research /ID# 212921
Sunrise, Florida, 33351-7311
Lenus Research & Medical Group /ID# 212584
Sweetwater, Florida, 33172
WDC Cosmetic and Research, PLLC /ID# 210372
Wilmington, North Carolina, 28403
Puerto Rico3 sites
Dr. Samuel Sanchez, PSC /ID# 211142
Caguas, 00727
Pan American Center for Oncology Trials, LLC /ID# 212445
Rio Piedras, 00935
Clinical Research Puerto Rico /ID# 211144
San Juan, 0090
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Risankizumab Using a New Formulation for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.
Read the detailed description
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of risankizumab 150 mg/mL formulation in PFS in adult participants with moderate to severe plaque psoriasis. The study included a 30-day screening period, a 28-week treatment period with study visits at Weeks 0, 4, 16 and 28, and a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug. Study drug dosing consisted of 3 self-administered, subcutaneous (SC) doses on Weeks 0, 4, and 16. Dosing on Week 4 was self-administered at home.
- Conditions
- Psoriasis
- Being tested
- Risankizumab, Placebo solution for risankizumab
- Keywords
- Risankizumab, Psoriasis, 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
Risankizumab 150 mg (150 mg/mL) in prefilled syringes, self-administered subcutaneously
Placebo solution for risankizumabDrug
Placebo solution in prefilled syringes, self-administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Risankizumab | Experimental | Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16 Receives: Drug: Risankizumab |
| Placebo | Placebo comparator | Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16 Receives: Drug: Placebo solution for risankizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100.
Measured: At Week 16
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.
Measured: At Week 16
Secondary outcomes (2)
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100.
Measured: At Week 16
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear at Week 16
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.
Measured: At Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start13 May 2019
- Primary completion20 Feb 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 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
- NCT03875482
- Sponsor's protocol ID
- M15-999
- Status last verified
- Feb 2021
- First submitted
- 13 Mar 2019
- Last updated
- 16 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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
Blauvelt A, Gordon KB, Lee P, Bagel J, Sofen H, Lockshin B, Soliman AM, Geng Z, Zhan T, Alperovich G, Stein Gold L. Efficacy, safety, usability, and acceptability of risankizumab 150 mg formulation administered by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis. J Dermatolog Treat. 2022 Jun;33(4):2085-2093. doi: 10.1080/09546634.2021.1914812. Epub 2021 May 5.
PubMed 33947295
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Risankizumab Using a New Formulation for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03875482
- Acronym / sponsor ID
- M15-999
- Conditions
- Psoriasis
- Keywords
- Risankizumab, Psoriasis, Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 13 May 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Posted 16 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.
Detailed description
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of risankizumab 150 mg/mL formulation in PFS in adult participants with moderate to severe plaque psoriasis. The study included a 30-day screening period, a 28-week treatment period with study visits at Weeks 0, 4, 16 and 28, and a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug. Study drug dosing consisted of 3 self-administered, subcutaneous (SC) doses on Weeks 0, 4, and 16. Dosing on Week 4 was self-administered at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risankizumab | Experimental | Drug: RisankizumabSubcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16 |
| Placebo | Placebo comparator | Drug: Placebo solution for risankizumabSubcutaneous (SC), self-administered doses of placebo solution 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 (4 listed)
- Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit.
- Participant meets following disease activity criteria:
- Stable moderate to severe chronic plaque psoriasis, defined as greater than or equal to 10% body surface area (BSA) psoriasis involvement, static physician global assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity Index (PASI) greater than or equal to 12 at Screening and baseline visit.
- Candidate for systemic therapy as assessed by the investigator.
Key exclusion criteria (3 listed)
- Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis.
- Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
- Participant has previous exposure to risankizumab.
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 655066Risankizumab 150 mg (150 mg/mL) in prefilled syringes, self-administered subcutaneously | Drug | Risankizumab |
| Placebo solution for risankizumabPlacebo solution in prefilled syringes, self-administered subcutaneously | Drug | Placebo |
Primary outcome
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16
Time frame: At Week 16
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline * 100.
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16
Time frame: At Week 16
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.
2 secondary outcomes
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16
Time frame: At Week 16
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear at Week 16
Time frame: At Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33947295Blauvelt A, Gordon KB, Lee P, Bagel J, Sofen H, Lockshin B, Soliman AM, Geng Z, Zhan T, Alperovich G, Stein Gold L. Efficacy, safety, usability, and acceptability of risankizumab 150 mg formulation administered by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis. J Dermatolog Treat. 2022 Jun;33(4):2085-2093. doi: 10.1080/09546634.2021.1914812. Epub 2021 May 5.
- Related Info.Link provided by the sponsor.
- 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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Plaque Psoriasis
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
43 sites in 2 countries: 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 43 sites in 2 countries.
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 4 inclusion and 3 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 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Puerto Rico. 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?
Yes. Results are posted in the registry (first posted 16 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16 (time frame: At Week 16). The study lists 2 primary outcomes in all. 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 NCT03875482, 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 16 Mar 2021; AzTrials last refreshed its copy on 1 Nov 2026.