PsoriasisPhase 3OptIMMize-2NCT04862286
Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 6 and 17 Years With Moderate to Severe Plaque Psoriasis Treated With Subcutaneous (SC) Injection of Risankizumab Who Have Completed Participation in Study M19-977
A Phase 3 study testing Risankizumab in people with Psoriasis, run by AbbVie at 41 sites in 7 countries.
Trial summary
Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. This study evaluates adverse events and change in disease activity with risankizumab in pediatric participants with moderate to severe plaque psoriasis who completed the study… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Risankizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 41 sitesin 7 countries
- Study dates
- 24 Jul 2021to Apr 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- --Participants who have completed participation in study M19-977 and who meet all eligibility criteria for participation in Study M19-973 will be allowed to enroll in study M19-973.
Who cannot join
- --Participants who have developed any discontinuation criteria as defined in Study M19-977.
Trial locations and contacts
41 sites in 7 countries.
41 sites in 7 countries
United States15 sites
UAB Department of Dermatology /ID# 252305
Birmingham, Alabama, 35233
Medical University of South Carolina /ID# 248831
Charleston, South Carolina, 29425
Univ Hosp Cleveland /ID# 248825
Cleveland, Ohio, 44106
University Dermatology and Vein Clinic, LLC /ID# 226100
Darien, Illinois, 60561
First OC Dermatology /ID# 226942
Fountain Valley, California, 92708
Solutions Through Adv Rch /ID# 226104
Jacksonville, Florida, 32256
Apex Clinical Research Center /ID# 248830
Mayfield Heights, Ohio, 44124
Wisconsin Medical Center /ID# 263437
Milwaukee, Wisconsin, 53226
West Virginia University Hospitals /ID# 263438
Morgantown, West Virginia, 26506
Skin Cancer and Dermatology Institute - Reno /ID# 248828
Reno, Nevada, 89509
Arlington Dermatology /ID# 226097
Rolling Meadows, Illinois, 60008
Integrative Skin Science and Research /ID# 226108
Sacramento, California, 95815
University of California San Diego - Rady Children's Hospital San Diego /ID# 252348
San Diego, California, 92123
Olympian Clinical Research- St. Petersburg /ID# 226106
St. Petersburg, Florida, 33709-1405
Advanced Clinical Research Institute /ID# 248827
Tampa, Florida, 33607
Germany6 sites
Fachklinik Bad Bentheim /ID# 243904
Bad Bentheim, Lower Saxony, 48455
Universitaetsklinikum Bonn /ID# 243910
Bonn, North Rhine-Westphalia, 53127
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 243908
Dresden, Saxony, 01307
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 243883
Kiel, Schleswig-Holstein, 24105
Universitaetsmedizin Mainz /ID# 243907
Mainz, Rhineland-Palatinate, 55131
Universitaetsklinikum Muenster /ID# 243905
Münster, North Rhine-Westphalia, 48149
Poland5 sites
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 243849
Gdansk, Pomeranian Voivodeship, 80-546
Dermed Centrum Medyczne Sp. z o.o /ID# 243847
Lodz, Łódź Voivodeship, 90-265
Dermoklinika Medical Center /ID# 243848
Lodz, Łódź Voivodeship, 90-436
Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 243850
Rzeszów, Podkarpackie Voivodeship, 35-055
High-Med Przychodnia Specjalistyczna /ID# 243846
Warsaw, Masovian Voivodeship, 01-817
Spain5 sites
Hospital Sant Joan de Deu /ID# 241103
Esplugues de Llobregat, Barcelona, 08950
Hospital General Universitario Gregorio Maranon /ID# 241099
Madrid, 28007
Hospital Universitario Infanta Leonor /ID# 241100
Madrid, 28031
Hospital Universitario 12 de Octubre /ID# 241102
Madrid, 28041
Complejo Hospitalario Universitario de Pontevedra /ID# 241101
Pontevedra, 36071
Japan4 sites
Kansai Medical University Hirakata Hospital /ID# 252332
Hirakata-shi, Osaka, 573-1191
Nagoya City University Hospital /ID# 248429
Nagoya, Aichi-ken, 467-8602
Tokyo Medical University Hospital /ID# 252331
Shinjuku-ku, Tokyo, 160-0023
Mie University Hospital /ID# 263008
Tsu, Mie-ken, 514-8507
United Kingdom4 sites
Royal Devon & Exeter Hospital /ID# 245101
Exeter, Devon, EX2 5DW
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 245100
London, Greater London, SE1 9RT
Chelsea and Westminster Hospital /ID# 245102
London, Greater London, SW10 9NH
Derriford Hospital and the Royal Eye Infirmary /ID# 245104
Plymouth, Devon, PL6 8DH
Canada2 sites
Karma Clinical Trials /ID# 233985
St. John's, Newfoundland and Labrador, A1A 4Y3
Hospital for Sick Children /ID# 233986
Toronto, Ontario, M5G 1X8
About this study
Official title: OptIMMize-2: A Phase 3 Multicenter, Single-arm, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Risankizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Completed Participation in Study M19-977 (OptIMMize-1)
Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. This study evaluates adverse events and change in disease activity with risankizumab in pediatric participants with moderate to severe plaque psoriasis who completed the study M19-977.
Risankizumab is an approved drug for treatment of moderate to severe plaque psoriasis in adults and is being studied in the pediatric population (6 to 17 years). A maximum of 132 participants will be enrolled in the study across approximately 50 sites worldwide.
Read more
Participants will receive subcutaneous injection of risankizumab every 12 weeks for 204 weeks and are followed up for safety for 20 weeks after last dose.
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.
- Conditions
- Psoriasis
- Being tested
- Risankizumab
- Keywords
- Plaque Psoriasis, Risankizumab, SKYRIZI, ABBV-066, BI 655066, Risankizumab-rzaa
- 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, SKYRIZI, risankizumab-rzaa
Subcutaneous (SC) injection.
| Study group | Role | What they receive |
|---|---|---|
| Risankizumab | Experimental | Participants will receive risankizumab subcutaneous (SC) injection every 12 weeks for 204 weeks. Receives: Drug: Risankizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
Measured: Up to approximately 224 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start24 Jul 2021
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 132 participants (estimated)
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
- NCT04862286
- Sponsor's protocol ID
- M19-973
- Other IDs
- 2022-500408-22-00
- Acronym
- OptIMMize-2
- Status last verified
- Aug 2025
- First submitted
- 26 Apr 2021
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OptIMMize-2: A Phase 3 Multicenter, Single-arm, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Risankizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Completed Participation in Study M19-977 (OptIMMize-1)
- ClinicalTrials.gov ID
- NCT04862286
- Acronym / sponsor ID
- OptIMMize-2 / M19-973
- Conditions
- Psoriasis
- Keywords
- Plaque Psoriasis, Risankizumab, SKYRIZI, ABBV-066, BI 655066, Risankizumab-rzaa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2021 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 27 Apr 2021 (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.
Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. This study evaluates adverse events and change in disease activity with risankizumab in pediatric participants with moderate to severe plaque psoriasis who completed the study M19-977.
Risankizumab is an approved drug for treatment of moderate to severe plaque psoriasis in adults and is being studied in the pediatric population (6 to 17 years). A maximum of 132 participants will be enrolled in the study across approximately 50 sites worldwide.
Participants will receive subcutaneous injection of risankizumab every 12 weeks for 204 weeks and are followed up for safety for 20 weeks after last dose.
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.
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: RisankizumabParticipants will receive risankizumab subcutaneous (SC) injection every 12 weeks for 204 weeks. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- --Participants who have completed participation in study M19-977 and who meet all eligibility criteria for participation in Study M19-973 will be allowed to enroll in study M19-973.
Key exclusion criteria (1 listed)
- --Participants who have developed any discontinuation criteria as defined in Study M19-977.
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 655066, SKYRIZI, risankizumab-rzaaSubcutaneous (SC) injection. | Drug | Risankizumab |
Primary outcome
Number of Participants With Adverse Events
Time frame: Up to approximately 224 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
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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
41 sites in 7 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 41 sites in 7 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Germany, Poland, Spain, Japan and 2 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Participants With Adverse Events (time frame: Up to approximately 224 weeks). 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 12 Aug 2025.