PsoriasisPhase 3NCT02694523

BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis

A Phase 3 study testing risankizumab and adalimumab in people with Psoriasis, run by AbbVie.

Completed

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

Trial summary

This is a randomized double blind, double dummy, active comparator controlled, parallel design study that is performed to assess the safety and efficacy of BI 655066/ABBV-066 (risankizumab) compared to adalimumab to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients. 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 adalimumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 684 participants
Where: No sites listed yet
Study dates: Mar 2016to Aug 2017
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

Male or female patients. Women of childbearing potential* must be ready and able to use highly effective methods of birth control per ICH M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
Women of childbearing potential are defined as:
having experienced menarche and
not postmenopausal (12 months with no menses without an alternative medical cause) and
not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy).
Age ≥ 18 years at screening

Show all 14Show fewer

Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the patient.
Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization):
Have an involved body surface area (BSA) ≥ 10% and
Have a Psoriasis Area and Severity Index (PASI) score ≥ 12 and
Have a static Physician Global Assessment (sPGA) score of ≥ 3.
Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator
Must be candidates for treatment with adalimumab (Humira®) according to local label as confirmed by the investigator.
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Who cannot join

Patients with
non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)
current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
active ongoing inflammatory diseases other than psoriasis that might confound trial evaluations according to investigator's judgment
Previous exposure to ABBV-066
Previous exposure to adalimumab (Humira®)

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Currently enrolled in another investigational study or less than 30 days or more from screening since completing another investigational drug or device study.
Use of any restricted medication or any drug considered likely to interfere with the safe conduct of the study.
Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g. hip replacement, removal aneurysm, stomach ligation).
Known chronic or relevant acute infections, such as active tuberculosis (TB), human immunodeficiency virus (HIV) or viral hepatitis; QuantiFERON® TB test or purified protein derivative (PPD) skin test will be performed according to local labelling for Humira®. If the result is positive, patients may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active TB. If presence of latent TB is established, then treatment should have been initiated and maintained according to local country guidelines.
Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and electrocardiogram [ECG]), or laboratory value at the Screening Visit outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data.
History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Previous enrolment in this trial

About this study

Official title: BI 655066/ABBV-066 (Risankizumab) Versus Adalimumab in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment and After Inadequate Adalimumab Treatment Response (IMMvent)

Read the detailed description

This study consists of 2 parts (Part A and Part B).

Part A:

Participants were randomized to receive either risankizumab or adalimumab.

Part B:

Participants who received risankizumab in Part A continued to receive risankizumab in Part B
Adalimumab nonresponders (<PASI 50 at Week 16) switched to risankizumab in Part B;
Adalimumab responders (PASI 90 at Week 16) continued to received adalimumab in Part B;
Adalimumab inadequate responders (PASI 50 to <PASI 90) were rerandomized to receive either risankizumab or adalimumab in Part B.

Conditions: Psoriasis
Being tested: risankizumab, adalimumab, placebo for risankizumab, placebo for adalimumab
Keywords: Psoriasis, Skin Diseases, Skin Diseases, Papulosquamous, Adalimumab, Anti-Inflammatory Agents, ABBV-066, BI 655066, Risankizumab
Medical subject headings: Psoriasis, Skin Diseases, Skin Diseases, Papulosquamous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

risankizumabDrug
Also called BI 655066, ABBV-066, SKYRIZI
Risankizumab administered by subcutaneous (SC) injection
adalimumabBiological
Also called Humira, ABT-D2E7
Adalimumab pre-filled syringe, administered by subcutaneous (SC) injection
placebo for risankizumabDrug
Placebo risankizumab administered by subcutaneous (SC) injection
placebo for adalimumabBiological
Placebo for adalimumab pre-filled syringe, administered by subcutaneous (SC) injection

Study groups in NCT02694523
Study group	Role	What they receive
Adalimumab (Part A)	Active comparator	Participants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A). Receives: Biological: adalimumab; Drug: placebo for risankizumab
Risankizumab (Part A)	Experimental	Participants randomized to receive risankizumab at Weeks 0 and 4 (Part A). Receives: Drug: risankizumab; Biological: placebo for adalimumab

What is being measured

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

Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)
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 follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.
Measured: Week 16
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) 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. NRI was used for missing data.
Measured: Week 16
Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B)
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 follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Measured: Week 44

Secondary outcomes (4)

Percentage of Participants Achieving PASI75 at Week 16 (Part A)
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. PASI75 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 follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Measured: Week 16
Percentage of Participants Achieving PASI100 at Week 16 (Part A)
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 follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Measured: Week 16
Percentage of Participants Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI100 at Week 44 (Part B)
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 follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.
Measured: Week 44
Percentage of Participants Who Were ReRandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear at Week 44 (Part B)
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) 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. NRI was used for missing data.
Measured: Week 44

Timeline

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

Mar 2016Aug 2017

First posted29 Feb 2016 (estimated)
Study startMar 2016
Primary completionAug 2017
Study completionAug 2017

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 (5)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: Double blind
Who is masked: Participant, Investigator
Enrolment: 684 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02694523
Sponsor's protocol ID: M16-010
Other IDs: 2015-003623-65, 1311.30, 2015
Status last verified: Jul 2021
First submitted: 24 Feb 2016
Last updated: 30 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Reich K, Gooderham M, Thaci D, Crowley JJ, Ryan C, Krueger JG, Tsai TF, Flack M, Gu Y, Williams DA, Thompson EHZ, Paul C. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019 Aug 17;394(10198):576-586. doi: 10.1016/S0140-6736(19)30952-3. Epub 2019 Jul 4.
PubMed 31280967
Hsieh CY, Hsu FL, Tsai TF. Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2607-2620. doi: 10.1007/s13555-024-01229-6. Epub 2024 Jul 29.
PubMed 39073712
Lebwohl MG, Soliman AM, Yang H, Wang J, Hagan K, Padilla B, Pinter A. Impact of Risankizumab on PASI90 and DLQI0/1 Duration in Moderate-to-Severe Psoriasis: A Post Hoc Analysis of Four Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2022 Feb;12(2):407-418. doi: 10.1007/s13555-021-00660-3. Epub 2021 Dec 18.
PubMed 34921669
Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.
PubMed 31667790
Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. doi: 10.1007/s40262-019-00759-z.
PubMed 31054118

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
RecruitingObservational study
Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
Osteoporosis, Inflammatory Rheumatism
RecruitingPhase 1
A Study of HL40626S Tablets in Healthy Adults
Skin Disease, Immune System Disease
RecruitingObservational study
Metabolic Profiling of Immune Responses in Immune-mediated Diseases
Primary Immunodeficiency, Psoriasis
Active, not recruitingObservational study
Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden
Psoriasis, Moderate to Severe Psoriasis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BI 655066/ABBV-066 (Risankizumab) Versus Adalimumab in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment and After Inadequate Adalimumab Treatment Response (IMMvent)
ClinicalTrials.gov ID: NCT02694523
Acronym / sponsor ID: M16-010
Conditions: Psoriasis
Keywords: Psoriasis, Skin Diseases, Skin Diseases, Papulosquamous, Adalimumab, Anti-Inflammatory Agents, ABBV-066, BI 655066, Risankizumab
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 684 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Collaborators: Boehringer Ingelheim
Study start: Mar 2016 (actual)
Primary completion: Aug 2017 (actual)
Study completion: Aug 2017 (actual)
First posted: 29 Feb 2016 (estimated)
Results: Posted 28 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study consists of 2 parts (Part A and Part B).

Part A:

Participants were randomized to receive either risankizumab or adalimumab.

Part B:

Participants who received risankizumab in Part A continued to receive risankizumab in Part B
Adalimumab nonresponders (<PASI 50 at Week 16) switched to risankizumab in Part B;
Adalimumab responders (PASI 90 at Week 16) continued to received adalimumab in Part B;
Adalimumab inadequate responders (PASI 50 to <PASI 90) were rerandomized to receive either risankizumab or adalimumab in Part B.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Adalimumab (Part A)	Active comparator	Biological: adalimumab, Drug: placebo for risankizumabParticipants randomized to receive double-blind (DB) adalimumab 80 mg by subcutaneous (SC) injection at Week 0, then 40 mg at Week 1 and every 2 weeks for 15 weeks (Part A).
Risankizumab (Part A)	Experimental	Drug: risankizumab, Biological: placebo for adalimumabParticipants randomized to receive risankizumab at Weeks 0 and 4 (Part A).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Male or female patients. Women of childbearing potential* must be ready and able to use highly effective methods of birth control per ICH M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
Age ≥ 18 years at screening
Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the patient.
Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization):
Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator

Key exclusion criteria (15 listed)

Patients with
Previous exposure to ABBV-066
Previous exposure to adalimumab (Humira®)
Currently enrolled in another investigational study or less than 30 days or more from screening since completing another investigational drug or device study.
Use of any restricted medication or any drug considered likely to interfere with the safe conduct of the study.

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: BI 655066, ABBV-066, SKYRIZIRisankizumab administered by subcutaneous (SC) injection	Drug	Risankizumab (Part A)
adalimumabAlso: Humira, ABT-D2E7Adalimumab pre-filled syringe, administered by subcutaneous (SC) injection	Biological	Adalimumab (Part A)
placebo for risankizumabPlacebo risankizumab administered by subcutaneous (SC) injection	Drug	Adalimumab (Part A)
placebo for adalimumabPlacebo for adalimumab pre-filled syringe, administered by subcutaneous (SC) injection	Biological	Risankizumab (Part A)

Primary outcome

Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)
Time frame: Week 16
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 follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)
Time frame: Week 16
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) 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. NRI was used for missing data.
Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B)
Time frame: Week 44
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 follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

4 secondary outcomes

Percentage of Participants Achieving PASI75 at Week 16 (Part A)
Time frame: Week 16
Percentage of Participants Achieving PASI100 at Week 16 (Part A)
Time frame: Week 16
Percentage of Participants Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI100 at Week 44 (Part B)
Time frame: Week 44
Percentage of Participants Who Were ReRandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear at Week 44 (Part B)
Time frame: Week 44

Results and safety

Results posted to the registry on 28 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adalimumab (Part A)	304	291
Risankizumab (Part A)	301	294
Risankizumab/Risankizumab (Part B)	0	0
Adalimumab/Adalimumab (Part B)	0	0
Adalimumab/Risankizumab (Part B)	0	0
Adalimumab/Rerandomized to Adalimumab (Part B)	0	0
Adalimumab/Rerandomized to Risankizumab (Part B)	0	0

Primary outcome: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)

Time frame: Week 16. Number. Unit: percentage of participants

Measure	Adalimumab (Part A) n = 304	Risankizumab (Part A) n = 301
Value	47.4	72.4

Adalimumab (Part A) vs Risankizumab (Part A): difference in percentage of participants: 24.9 (95% CI 17.5 to 32.4), p <0.001, Cochran-Mantel-Haenszel

Population analysed: Intent-to-treat population in Part A (ITT\_A): All subjects randomized at Baseline.

Primary outcome: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)

Time frame: Week 16. Number. Unit: percentage of participants

Measure	Adalimumab (Part A) n = 304	Risankizumab (Part A) n = 301
Value	60.2	83.7

Adalimumab (Part A) vs Risankizumab (Part A): difference in percentage of participants: 23.3 (95% CI 16.6 to 30.1), p <0.001, Cochran-Mantel-Haenszel

Population analysed: ITT\_A population.

Primary outcome: Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B)

Time frame: Week 44. Number. Unit: percentage of participants

Measure	Adalimumab/Rerandomized to Adalimumab (Part B) n = 56	Adalimumab/Rerandomized to Risankizumab (Part B) n = 53
Value	21.4	66.0

Adalimumab/Rerandomized to Adalimumab (Part B) vs Adalimumab/Rerandomized to Risankizumab (Part B): difference in percentage of participants: 45.0 (95% CI 28.9 to 61.1), p <0.001, Cochran-Mantel-Haenszel

Population analysed: Intent-to-treat population in Part B who were re-randomized (ITT\_B\_RR): All subjects who started with adalimumab at Baseline and were re-randomized at Week 16

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 48 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adalimumab (Part A)	9 of 304 (3%)	71 of 304 (23.4%)	2 of 304
Risankizumab (Part A)	10 of 301 (3.3%)	76 of 301 (25.2%)	1 of 301
Risankizumab/Risankizumab (Part B)	12 of 294 (4.1%)	95 of 294 (32.3%)	0 of 294
Adalimumab/Risankizumab (Part B)	4 of 38 (10.5%)	16 of 38 (42.1%)	0 of 38
Adalimumab/Rerandomized to Adalimumab (Part B)	2 of 56 (3.6%)	21 of 56 (37.5%)	0 of 56
Adalimumab/Rerandomized to Risankizumab (Part B)	3 of 53 (5.7%)	24 of 53 (45.3%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31280967Reich K, Gooderham M, Thaci D, Crowley JJ, Ryan C, Krueger JG, Tsai TF, Flack M, Gu Y, Williams DA, Thompson EHZ, Paul C. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019 Aug 17;394(10198):576-586. doi: 10.1016/S0140-6736(19)30952-3. Epub 2019 Jul 4.
Derived from this study: PubMed 39073712Hsieh CY, Hsu FL, Tsai TF. Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2607-2620. doi: 10.1007/s13555-024-01229-6. Epub 2024 Jul 29.
Derived from this study: PubMed 34921669Lebwohl MG, Soliman AM, Yang H, Wang J, Hagan K, Padilla B, Pinter A. Impact of Risankizumab on PASI90 and DLQI0/1 Duration in Moderate-to-Severe Psoriasis: A Post Hoc Analysis of Four Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2022 Feb;12(2):407-418. doi: 10.1007/s13555-021-00660-3. Epub 2021 Dec 18.
Derived from this study: PubMed 31667790Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.
Derived from this study: PubMed 31054118Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. doi: 10.1007/s40262-019-00759-z.
Related InfoLink provided by the sponsor.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing risankizumab and adalimumab in people with Psoriasis, run by AbbVie.

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 14 inclusion and 15 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 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

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 28 May 2019). 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 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (time frame: Week 16). 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 NCT02694523, which also lists 5 linked publications.

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 30 Jul 2021.