PsoriasisPhase 3NCT03875508
A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing Risankizumab and Autoinjector in people with Psoriasis, run by AbbVie at 26 sites in United States.
Trial summary
The objectives of this study were to evaluate the usability of the combination product of risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and tolerability of risankizumab administered by AI 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 and Autoinjector
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 26 sitesUnited States
- Study dates
- 4 Jun 2019to 25 Aug 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 ≥ 10% body surface area (BSA) psoriasis involvement, static Physician Global Assessment (sPGA) score ≥ 3, and Psoriasis Area Severity Index (PASI) ≥ 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
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Bakersfield Derma & Skin Cance /ID# 210773
Bakersfield, California, 93309
Great Lakes Research, Inc. /ID# 210192
Bay City, Michigan, 48602
Florida Academic Centers Research /ID# 210337
Coral Gables, Florida, 33134
Center for Clinical Studies /ID# 211565
Cypress, Texas, 77433
Encino Research Center / T. Jo /ID# 211735
Encino, California, 91436
Tien Q Nguyen MD, Inc /ID# 210775
Fountain Valley, California, 92708-3701
Advanced Research Associates /ID# 210634
Glendale, Arizona, 85308
Medication Management, LLC /ID# 213217
Greensboro, North Carolina, 27408
Burke Pharmaceutical Research /ID# 211386
Hot Springs, Arkansas, 71913-6404
Center for Clinical Studies /ID# 210362
Houston, Texas, 77004
Suzanne Bruce and Associates /ID# 212210
Houston, Texas, 77056
Froedtert Mem Lutheran Hosp /ID# 210194
Milwaukee, Wisconsin, 53226
Medallion Clinical Research Institute, LLC /ID# 210329
Naples, Florida, 34102
Renstar Medical Research /ID# 210878
Ocala, Florida, 34470
Epiphany Dermatology /ID# 211493
Overland Park, Kansas, 66215
Austin Institute for Clinical Research /ID# 212203
Pflugerville, Texas, 78660
University of Pittsburgh MC /ID# 210839
Pittsburgh, Pennsylvania, 15260
Oregon Medical Res Center PC /ID# 210334
Portland, Oregon, 97223
AllCutis Research Inc /ID# 211429
Portsmouth, New Hampshire, 03801
DermAssociates /ID# 210838
Rockville, Maryland, 20850
UC Davis Health /ID# 210411
Sacramento, California, 95816
Cognitive Clinical Trials /ID# 210770
Scottsdale, Arizona, 85258-4446
Dermatology Physicians of CT /ID# 210637
Shelton, Connecticut, 06484-6211
Premier Clinical Research /ID# 212209
Spokane, Washington, 99202
Central Dermatology, PC /ID# 210301
St Louis, Missouri, 63117
Somerset Skin Centre /ID# 211596
Troy, Michigan, 48084
About this study
Official title: Plaque Psoriasis: Usability of the Risankizumab Autoinjector Combination Product in Adults With Moderate to Severe Psoriasis
The objectives of this study were to evaluate the usability of the combination product of risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and tolerability of risankizumab administered by AI for the treatment of adult participants with moderate to severe plaque psoriasis.
Read the detailed description
This was a Phase 3 multicenter, single-arm, open-label study that evaluated usability and efficacy of the risankizumab-AI combination product. The study included a 30-day screening period with study visits at Weeks 0, 4, 16, 28, and 40 with a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug (Week 48). Study drug dosing consisted of 4 self-administered doses given subcutaneously on Weeks 0, 4, 16, and 28. Dosing on Weeks 4 and 16 was self-administered at home.
- Conditions
- Psoriasis
- Being tested
- Risankizumab, Autoinjector
- Keywords
- Psoriasis, Risankizumab, 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 to be injected subcutaneously (SC)
AutoinjectorDevice
Single dose pre-filled autoinjector containing risankizumab for SC injection
| Study group | Role | What they receive |
|---|---|---|
| Risankizumab | Experimental | Risankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28 Receives: Drug: Risankizumab; Device: Autoinjector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With an Observer Rating of Successful Participant Self-administration
Successful participant self-administration is defined as successfully completed the sequence of 4 critical steps in the Instructions for Use (IFU) without errors to administer study drug via the autoinjector. The steps are "chose an appropriate injection site"; "removed cap from autoinjector"; "activated the injection"; and "performed a complete injection".
Measured: Day 1 and Week 28
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. PASI 90 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
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. PASI 100 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 Psoriasis Area Severity Index (PASI) 75 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. PASI 75 is defined as at least a 75% 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 Who Had No Potential Hazards as Measured by an Observer
Potential hazards are measured by an observer on the possible use-related hazards checklist for self-administration with the autoinjector. Hazards include injection at incorrect site; administration delayed because of cap removal difficulties; slip hazard during cap disposal attempt; small component swallowed after incorrect disposal of cap; patient received less medication than intended; needle shield did not deploy and resulted in sharps exposure; and pen not discarded properly and resulted in a biohazard for others.
Measured: Day 1 and Week 28
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ)
Participants completed the Self-Injection Assessment Questionnaire (SIAQ), an instrument previously validated in those with rheumatoid arthritis, on an electronic patient-report outcome (ePRO) device. The POST module includes four principal causal domains: feelings about injections, self-confidence, pain and reaction during or after the injection, and ease of use, plus two additional domains on satisfaction with self-injection and self-image. Participants rate each item of the SIAQ 20 to 40 minutes following injections, and the ratings are transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Higher domain scores indicate wider acceptability by subjects to use the autoinjector.
Measured: Day 1, Week 4, Week 16, Week 28
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 start4 Jun 2019
- Primary completion24 Apr 2020
- Study completion25 Aug 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 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
- NCT03875508
- Sponsor's protocol ID
- M16-005
- Status last verified
- Apr 2021
- First submitted
- 13 Mar 2019
- Last updated
- 11 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plaque Psoriasis: Usability of the Risankizumab Autoinjector Combination Product in Adults With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT03875508
- Acronym / sponsor ID
- M16-005
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Risankizumab, Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 24 Apr 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Posted 11 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study were to evaluate the usability of the combination product of risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and tolerability of risankizumab administered by AI for the treatment of adult participants with moderate to severe plaque psoriasis.
Detailed description
This was a Phase 3 multicenter, single-arm, open-label study that evaluated usability and efficacy of the risankizumab-AI combination product. The study included a 30-day screening period with study visits at Weeks 0, 4, 16, 28, and 40 with a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug (Week 48). Study drug dosing consisted of 4 self-administered doses given subcutaneously on Weeks 0, 4, 16, and 28. Dosing on Weeks 4 and 16 was self-administered at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risankizumab | Experimental | Drug: Risankizumab, Device: AutoinjectorRisankizumab solution (150 mg/mL) for injection; self-administered subcutaneously via a pre-filled autoinjector at Weeks 0, 4, 16, and 28 |
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:
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 to be injected subcutaneously (SC) | Drug | Risankizumab |
| AutoinjectorSingle dose pre-filled autoinjector containing risankizumab for SC injection | Device | Risankizumab |
Primary outcome
Percentage of Participants With an Observer Rating of Successful Participant Self-administration
Time frame: Day 1 and Week 28
Successful participant self-administration is defined as successfully completed the sequence of 4 critical steps in the Instructions for Use (IFU) without errors to administer study drug via the autoinjector. The steps are "chose an appropriate injection site"; "removed cap from autoinjector"; "activated the injection"; and "performed a complete injection".
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. PASI 90 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.
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 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. PASI 100 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.
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 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. PASI 75 is defined as at least a 75% 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 Who Had No Potential Hazards as Measured by an Observer
Time frame: Day 1 and Week 28
Potential hazards are measured by an observer on the possible use-related hazards checklist for self-administration with the autoinjector. Hazards include injection at incorrect site; administration delayed because of cap removal difficulties; slip hazard during cap disposal attempt; small component swallowed after incorrect disposal of cap; patient received less medication than intended; needle shield did not deploy and resulted in sharps exposure; and pen not discarded properly and resulted in a biohazard for others.
Participant Rating of Acceptability by the Self-Injection Assessment Questionnaire (SIAQ)
Time frame: Day 1, Week 4, Week 16, Week 28
Participants completed the Self-Injection Assessment Questionnaire (SIAQ), an instrument previously validated in those with rheumatoid arthritis, on an electronic patient-report outcome (ePRO) device. The POST module includes four principal causal domains: feelings about injections, self-confidence, pain and reaction during or after the injection, and ease of use, plus two additional domains on satisfaction with self-injection and self-image. Participants rate each item of the SIAQ 20 to 40 minutes following injections, and the ratings are transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Higher domain scores indicate wider acceptability by subjects to use the autoinjector.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
26 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 and Autoinjector in people with Psoriasis, run by AbbVie at 26 sites in United States.
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 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. 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. 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 11 May 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 With an Observer Rating of Successful Participant Self-administration (time frame: Day 1 and Week 28). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2021.