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PsoriasisPhase 3OptIMMize-1NCT04435600

A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

A Phase 3 study testing Risankizumab and Ustekinumab in people with Psoriasis, run by AbbVie at 53 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. There is an unmet medical need for effective treatment in pediatric patients and this study is being done to evaluate risankizumab in pediatric participants with moderate to… 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 and Ustekinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
53 sitesin 7 countries
Study dates
14 Jul 2020to 15 Oct 2024
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 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diagnosis of chronic plaque psoriasis for at least 6 months before the Baseline Visit.
  • Stable severe or moderate to severe plaque psoriasis as defined in each study part by body surface area (BSA) psoriasis involvement and scores on the Psoriasis Area and Severity Index (PASI) and Static Physician Global Assessment (sPGA).
  • Candidate for systemic therapy as assessed by the investigator and meet the disease activity criteria at both the Screening and Baseline Visits per the protocol.

Who cannot join

  • Concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the participant's participation in this study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk by participating in the study.

Trial locations and contacts

53 sites in 7 countries.

53 sites in 7 countries

United States21 sites

  • Arlington Research Center, Inc /ID# 217471

    Arlington, Texas, 76011

  • UAB Department of Dermatology /ID# 218834

    Birmingham, Alabama, 35233

  • Medical University of South Carolina /ID# 217735

    Charleston, South Carolina, 29425

  • Univ Hosp Cleveland /ID# 228483

    Cleveland, Ohio, 44106

  • The Ohio State University /ID# 217808

    Columbus, Ohio, 43210

  • University Dermatology and Vein Clinic, LLC /ID# 222778

    Darien, Illinois, 60561

  • Rybear, Inc /ID# 223164

    Fort Lauderdale, Florida, 33316-1952

  • First OC Dermatology /ID# 217733

    Fountain Valley, California, 92708

  • Solutions Through Adv Rch /ID# 217936

    Jacksonville, Florida, 32256

  • Clinical Investigation Specialist, Inc - Kenosha /ID# 223161

    Kenosha, Wisconsin, 53144-1782

  • Duplicate_Forest Hills Dermatology Group /ID# 227941

    Kew Gardens, New York, 11415

  • Apex Clinical Research Center /ID# 228537

    Mayfield Heights, Ohio, 44124

  • Wisconsin Medical Center /ID# 240005

    Milwaukee, Wisconsin, 53226

  • West Virginia University Hospitals /ID# 228352

    Morgantown, West Virginia, 26506

  • Duplicate_Skin Cancer and Dermatology Institute (SCDI) /ID# 221738

    Reno, Nevada, 89052

  • Duplicate_Arlington Dermatology /ID# 217472

    Rolling Meadows, Illinois, 60008

  • Integrative Skin Science and Research /ID# 221741

    Sacramento, California, 95815

  • University of California San Diego - Rady Children's Hospital San Diego /ID# 217906

    San Diego, California, 92123

  • Olympian Clinical Research- St. Petersburg /ID# 217941

    St. Petersburg, Florida, 33709-1405

  • Advanced Clinical Research Institute /ID# 222706

    Tampa, Florida, 33607

  • Vital Prospects Clinical Research Institute, PC /ID# 217960

    Tulsa, Oklahoma, 74136-7049

Other trials in United States

Germany6 sites

  • Fachklinik Bad Bentheim /ID# 226014

    Bad Bentheim, Lower Saxony, 48455

  • Universitaetsklinikum Bonn /ID# 228880

    Bonn, North Rhine-Westphalia, 53127

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 228881

    Dresden, Saxony, 01307

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 226013

    Kiel, Schleswig-Holstein, 24105

  • Duplicate_Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 225987

    Mainz, Rhineland-Palatinate, 55131

  • Universitaetsklinikum Muenster /ID# 225988

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Japan6 sites

  • Kansai Medical University Hospital /ID# 231215

    Hirakata-shi, Osaka, 573-1191

  • Hiroshima University Hospital /ID# 256162

    Hiroshima, Hiroshima, 734-8551

  • Nagoya City University Hospital /ID# 230830

    Nagoya, Aichi-ken, 467-8602

  • Tokyo Medical University Hospital /ID# 230575

    Shinjuku-ku, Tokyo, 160-0023

  • Duplicate_Teikyo University Hospital /ID# 255188

    tabashi City, Tokyo, 173-8606

  • Mie University Hospital /ID# 230836

    Tsu, Mie-ken, 514-8507

Other trials in Japan

United Kingdom6 sites

  • Frimley Health NHS Foundation Trust /ID# 229525

    Camberley, Surrey, GU16 7UJ

  • Duplicate_Royal Devon University Healthcare NHS Foundation Trust /ID# 228078

    Exeter, Devon, EX2 5DW

  • NHS Greater Glasgow and Clyde /ID# 227226

    Glasgow, Scotland, G12 0XH

  • Guys and St Thomas NHS Foundation Trust /ID# 227224

    London, Greater London, SE1 9RT

  • Chelsea and Westminster Hospital /ID# 227231

    London, Greater London, SW10 9NH

  • Duplicate_University Hospital Plymouth NHS Trust /ID# 227230

    Plymouth, Devon, PL6 5FP

Other trials in United Kingdom

Poland5 sites

  • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228252

    Gdansk, Pomeranian Voivodeship, 80-546

  • Dermed Centrum Medyczne Sp. z o.o /ID# 226062

    Lodz, Łódź Voivodeship, 90-265

  • Dermoklinika Centrum Medyczne s.c. /ID# 226063

    Lodz, Łódź Voivodeship, 90-436

  • Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 226116

    Rzeszów, Podkarpackie Voivodeship, 35-055

  • High-Med Przychodnia Specjalistyczna /ID# 226060

    Warsaw, Masovian Voivodeship, 01-817

Other trials in Poland

Spain5 sites

  • Hospital Sant Joan de Deu /ID# 225722

    Esplugues de Llobregat, Barcelona, 08950

  • Hospital General Universitario Gregorio Maranon /ID# 225721

    Madrid, 28007

  • Hospital Universitario Infanta Leonor /ID# 225720

    Madrid, 28031

  • Hospital Universitario 12 de Octubre /ID# 227860

    Madrid, 28041

  • Complejo Hospitalario Universitario de Pontevedra /ID# 226061

    Pontevedra, 36071

Other trials in Spain

Canada4 sites

  • Duplicate_Dermatology Research Institute Inc. /ID# 226172

    Calgary, Alberta, T2J 7E1

  • CHU Sainte-Justine /ID# 226170

    Montreal, Quebec, H3T 1C5

  • Karma Clinical Trials /ID# 226177

    St. John's, Newfoundland and Labrador, A1A 4Y3

  • Hospital for Sick Children /ID# 226167

    Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

Official title: A Randomized, Active-Controlled, Efficacy Assessor-Blinded Study to Evaluate Pharmacokinetics, Safety and Efficacy of Risankizumab in Patients From 6 to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis

Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. There is an unmet medical need for effective treatment in pediatric patients and this study is being done to evaluate risankizumab in pediatric participants with moderate to severe plaque psoriasis. This study will assess the change in disease symptoms.

Risankizumab is a drug being studied for the treatment for plaque psoriasis in pediatric participants. This study has 4 parts.

Read more

Part 1: Participants aged 12 < 18 will receive a fixed dose of risankizumab. Part 2: Participants aged 12 < 18 will receive;

  • Period A: Risankizumab or ustekinumab based on body weight followed by;
  • Period B: Risankizumab or no treatment.
  • Period C: Re-treatment with risankizumab (if needed).

Part 3: Participants aged 6 < 12 will receive risankizumab based on body weight.

Part 4: Participants aged 6 < 12 will receive risankizumab based on body weight (Japan only: Participants aged 12 > 18 will receive risankizumab based on body weight).

Around 132 participants will be enrolled in approximately 50 sites worldwide.

Risankizumab and ustekinumab are given as a subcutaneous (under the skin) injection.

Parts 1, 3, and 4: Risankizumab for 40 weeks with a follow-up call 20 weeks later for a study duration of approximately 65 weeks.

Part 2:

  • Period A: Risankizumab or ustekinumab for 16 weeks.
  • Period B: Risankizumab or no treatment for 36 weeks.
  • Period C: Re-treatment with risankizumab for 16 weeks. Follow-up call 20 weeks later for a study duration of approximately 81 weeks. Participants from each Part who meet eligibility criteria for an open-label extension (OLE) study may continue on risankizumab for 216 additional weeks.

There may be a higher burden for study participants compared to standard treatment. Participants will attend monthly visits and medical assessments will check the effect of treatment through blood tests, questionnaires, and checking for side effects.

Conditions
Psoriasis
Being tested
Risankizumab, Ustekinumab
Keywords
Plaque Psoriasis, Risankizumab, Ustekinumab, Psoriasis, Biologic, ABBV-066, SKYRIZI
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 SKYRIZI, ABBV-066

    Subcutaneous Injection

  • UstekinumabDrug

    Subcutaneous Injection

Study groups in NCT04435600
Study groupRoleWhat they receive
Part 1: Risankizumab Dose AExperimentalParticipants age 12 to less than 18 receive fixed dose of risankizumab Dose A for 40 weeks.
Receives: Drug: Risankizumab
Part 2: Ustekinumab Dose A/B/C then Risankizumab Dose A/BExperimentalParticipants age 12 to less than 18 will receive: Period A: Ustekinumab Dose A, Dose B, or Dose C based on body weight for 16 weeks (at Week 0 and Week 4). Period B: Risankizumab Dose A or B based on body weight for 24 weeks.
Receives: Drug: Risankizumab; Drug: Ustekinumab
Part 2: Risankizumab Dose A/BExperimentalParticipants age 12 to less than 18 will receive: Period A: Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4). Period B: Participants who respond to Risankizumab in Period A are re-randomized to continue Risankizumab Dose A or B based on body weight for up to 24 weeks or withdraw from treatment until flare. Period C: Participants withdrawn from treatment in Period B and experience a flare in symptoms at Week 28 or beyond are eligible for re-treatment with Risankizumab Dose A or B based on body weight for 16 weeks (at Week 0 and Week 4).
Receives: Drug: Risankizumab
Part 3: Risankizumab Dose A/BExperimentalParticipants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks.
Receives: Drug: Risankizumab
Part 4: Risankizumab Dose A/BExperimentalParticipants age 6 to less than 12 will receive Risankizumab Dose A or B based on body weight for 40 weeks (Japan only: participants age 12 to less than 18 years will be included).
Receives: Drug: Risankizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)

    The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 75% improvement in PASI.

    Measured: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

  2. Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1)

    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).

    Measured: At Week 16 of initial treatment in each part of the study (Parts 1-4)

  3. Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline

    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).

    Measured: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

Secondary outcomes (16)

  1. Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)

    The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 90% improvement in PASI.

    Measured: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

  2. Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)

    The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 100% improvement in PASI.

    Measured: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

  3. Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (0 or 1)

    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).

    Measured: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

  4. Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline

    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).

    Measured: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

  5. Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)

    The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 50% improvement in PASI.

    Measured: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

  6. Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)

    The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 50% improvement in PASI.

    Measured: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

  7. Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)

    The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 90% improvement in PASI.

    Measured: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

  8. Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)

    The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 100% improvement in PASI.

    Measured: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

  9. Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI)

    The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 75% improvement in PASI.

    Measured: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

  10. Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score

    The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on quality of life (QOL). The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item was scored on a 4-point scale: 0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.

    Measured: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)

  11. Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score

    The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on quality of life (QOL). The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item was scored on a 4-point scale: 0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.

    Measured: Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)

  12. Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score

    The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on Quality of Life (QOL) of family members. It consists of 10 questions that assess the impact of skin diseases on different aspects of the family member's QOL. Each item was scored on a 4-point scale: 0 = not at all; 1 = a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.

    Measured: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)

  13. Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score

    The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on Quality of Life (QOL) of family members. It consists of 10 questions that assess the impact of skin diseases on different aspects of the family member's QOL. Each item was scored on a 4-point scale: 0 = not at all; 1 = a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.

    Measured: Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)

  14. Change From Baseline in Itch Numerical Rating Scale (Itch NRS)

    The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. A negative change from baseline indicates less intense itching and better outcomes.

    Measured: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)

  15. Change From Baseline in Itch Numerical Rating Scale (Itch NRS)

    The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. A negative change from baseline indicates less intense itching and better outcomes.

    Measured: Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)

  16. Percentage of Participants Achieving >= 4-point Improvement in the Itch Numerical Rating Scale (in Participants With Baseline Score >= 4)

    The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch within a 24-hour recall period. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving >= 4 point improvement in the itch NRS in participants with a baseline itch NRS score of >=4.

    Measured: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2020
  2. Study start14 Jul 2020
  3. Primary completion12 Feb 2024
  4. Study completion15 Oct 2024

Resources

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
Sequential
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04435600
Sponsor's protocol ID
M19-977
Other IDs
2023-504156-10-00, 2023
Acronym
OptIMMize-1
Status last verified
May 2025
First submitted
16 Jun 2020
Last updated
20 May 2025
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Risankizumab and Ustekinumab in people with Psoriasis, run by AbbVie at 53 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 3 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: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Germany, Japan, United Kingdom, Poland 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?

Yes. Results are posted in the registry (first posted 20 May 2025). 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) 75 (Defined as at Least 75% Improvement in PASI) (time frame: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)). The study lists 3 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 NCT04435600.

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 20 May 2025.

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