PsoriasisPhase 4NCT04908475

Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

A Phase 4 study testing Risankizumab and Apremilast in people with Psoriasis, run by AbbVie at 54 sites in 5 countries.

Completed

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

Trial summary

Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is compared to apremilast in adult participants with moderate 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 Apremilast
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 352 participants
Where: 54 sitesin 5 countries
Study dates: 9 Jun 2021to 20 Apr 2023
Phase: Phase 4
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

Candidates for systemic therapy with moderate chronic plaque psoriasis (PsO) (with or without psoriatic arthritis) at Screening and Baseline for at least 6 months prior to Baseline defined as:
Body Surface Area (BSA) >= 10% and <= 15%; and
Psoriasis Area and Severity Index (PASI) >= 12; and
Static Physician Global Assessment (sPGA) = 3 (moderate) based on a 5-point scale (0 to 4).

Who cannot join

Participant has any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO).
History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.
History of active ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with the assessment of PsO (e.g., hyperkeratotic eczema).
Prior exposure to risankizumab or apremilast.

Trial locations and contacts

54 sites in 5 countries.

Country

City, postcode or hospital

54 sites in 5 countries

United States26 sites

Arlington Research Center, Inc /ID# 229264
Arlington, Texas, 76011
Bellaire Dermatology Associates /ID# 230118
Bellaire, Texas, 77401
Total Skin and Beauty Dermatology Center /ID# 233793
Birmingham, Alabama, 35205
Michigan Center for Research Company /ID# 229136
Clarkston, Michigan, 48346
University Hospitals Case Medical Center /ID# 229240
Cleveland, Ohio, 44106
Florida Academic Centers Research and Education /ID# 229235
Coral Gables, Florida, 33134
Henry Ford Medical Center /ID# 229215
Detroit, Michigan, 48202-3046
Psoriasis Treatment Center of Central New Jersey /ID# 228943
East Windsor, New Jersey, 08520
Wright State Physicians - Fairborn /ID# 230051
Fairborn, Ohio, 45324-2640
Advanced Research Associates - Glendale /ID# 229266
Glendale, Arizona, 85308
Center for Clinical Studies - Houston (Binz) /ID# 229263
Houston, Texas, 77004-8097
Center for Clinical Studies - Houston (Binz) /ID# 229272
Houston, Texas, 77004-8097
Dawes Fretzin, LLC /ID# 229010
Indianapolis, Indiana, 46256
Olympian Clinical Research - Largo /ID# 233792
Largo, Florida, 33770
Physician Research Collaboration, LLC /ID# 229225
Lincoln, Nebraska, 68516
Renstar Medical Research /ID# 228946
Ocala, Florida, 34470
Advanced Dermatology of the Midlands /ID# 229009
Omaha, Nebraska, 68144-1105
Epiphany Dermatology of Kansas LLC /ID# 229221
Overland Park, Kansas, 66210
Alliance Dermatology and MOHs Center, PC /ID# 229224
Phoenix, Arizona, 85032
Oregon Dermatology and Research Center /ID# 233462
Portland, Oregon, 97210
DermAssociates, LLC /ID# 229016
Rockville, Maryland, 20850
Arlington Dermatology /ID# 228945
Rolling Meadows, Illinois, 60008
UC Davis Health /ID# 229133
Sacramento, California, 95816-3300
MediSearch Clinical Trials /ID# 229269
Saint Joseph, Missouri, 64506
Premier Clinical Research /ID# 229220
Spokane, Washington, 99202
ForCare Clinical Research /ID# 229135
Tampa, Florida, 33613-1244

Other trials in United States

Canada9 sites

Beacon Dermatology Inc /ID# 230121
Calgary, Alberta, T3E 0B2
Dermatrials Research /ID# 230119
Hamilton, Ontario, L8N 1Y2
Innovaderm Research Inc. /ID# 230334
Montreal, Quebec, H2X 2V1
Dr. S.K. Siddha Medicine Professional Corporation /ID# 230416
Newmarket, Ontario, L3Y 5G8
Centre de Recherche dermatologique du Quebec Metropolitain /ID# 230478
Québec, Quebec, G1V 4X7
Karma Clinical Trials /ID# 230339
St. John's, Newfoundland and Labrador, A1A 4Y3
Dr. Chih-ho Hong Medical Inc. /ID# 230337
Surrey, British Columbia, V3R 6A7
Enverus Medical Research /ID# 230480
Surrey, British Columbia, V3V 0C6
K. Papp Clinical Research /ID# 230336
Waterloo, Ontario, N2J 1C4

Other trials in Canada

Germany9 sites

Fachklinik Bad Bentheim /ID# 231504
Bad Bentheim, 48455
Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 230245
Bochum, 44793
Universitaetsklinikum Erlangen /ID# 229433
Erlangen, Bavaria, 91054
Universitaetsklinikum Frankfurt /ID# 229431
Frankfurt am Main, Hesse, 60590
SRH Wald-Klinikum Gera /ID# 229445
Gera, 07548
MENSINGDERMA research GmbH /ID# 229435
Hamburg, 22391
DermaKiel Allergie und Haut Centrum /ID# 229630
Kiel, Schleswig-Holstein, 24148
Dermatologische Gemeinschaftspraxis Mahlow /ID# 229434
Mahlow, 15831
Universitaetsklinikum Muenster /ID# 229432
Munster, Lower Saxony, 48149

Other trials in Germany

Poland6 sites

Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 228971
Elblag, Warmian-Masurian Voivodeship, 82-300
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 229053
Gdansk, Pomeranian Voivodeship, 80-546
Dermed Centrum Medyczne Sp. z o.o /ID# 229051
Lodz, Łódź Voivodeship, 90-265
Uniwersytecki Szpital Kliniczny im. F. Chopina w Rzeszowie /ID# 229022
Rzeszów, Podkarpackie Voivodeship, 35-055
High-Med Przychodnia Specjalistyczna /ID# 229023
Warsaw, Masovian Voivodeship, 01-817
Royalderm Agnieszka Nawrocka /ID# 228973
Warsaw, Masovian Voivodeship, 02-962

Other trials in Poland

Israel4 sites

HaEmek Medical Center /ID# 231901
Afula, Southern District, 1834111
Rambam Health Care Campus /ID# 229620
Haifa, H_efa, 3109601
Rabin Medical Center /ID# 229074
Haifa, H_efa, 4941492
The Chaim Sheba Medical Center /ID# 229075
Ramat Gan, Tel Aviv, 5265601

Other trials in Israel

About this study

Official title: A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor-blinded Study of Risankizumab Compared to Apremilast for the Treatment of Adult Subjects With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

Risankizumab (Skyrizi) and apremilast are approved drugs for the treatment of moderate to severe PsO. Approximately 330 participants with moderate plaque psoriasis (PsO) will be enrolled across approximately 55 sites globally.

The study has 2 periods : Period A from Baseline to Week 16, and Period B, from Week 16 to Week 52. In Period A, participants will be randomly placed into 2 groups to receive either subcutaneous risankizumab or oral apremilast for 16 weeks. In Period B, participants who received apremilast in Period A will again be randomly assigned to 1 of the 2 groups to receive either risankizumab or apremilast for 36 weeks. At weeks 28 and 40, participants considered non-responders to apremilast based on their psoriasis score will be offered to receive risankizumab.

There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

Conditions: Psoriasis
Being tested: Risankizumab, Apremilast
Keywords: Psoriasis, Plaque Psoriasis, Risankizumab, ABBV-066, Skyrizi, Apremilast
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, Skyrizi
Subcutaneous injection
ApremilastDrug
Also called Otezla
Oral Tablets

Study groups in NCT04908475
Study group	Role	What they receive
Risankizumab	Experimental	Risankizumab 150 mg as a single subcutaneous (SC) injection at at Baseline (Day 1) and Week 4 (Period A) and at Weeks 16, 28, and 40 (Period B). Receives: Drug: Risankizumab
Apremilast	Experimental	Participants receive apremilast 30 mg orally twice daily (BID) in Period A and re-randomized to receive either risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32 in Period B or apremilast 30 mg orally BID from Week 16 up to Week 52 in Period B. For those taking apremilast in Period B, non-responders at Week 28 and Week 40 will be offered to receive risankizumab as rescue medication. Receives: Drug: Risankizumab; Drug: Apremilast

What is being measured

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

Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A)
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 higher scores indicating more severe disease.
Measured: Week 16
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population at Week 16 (ITT_A)
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).
Measured: Week 16
Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
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 higher scores indicating more severe disease.
Measured: Week 52

Secondary outcomes (3)

Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A)
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 higher scores indicating more severe disease.
Measured: Week 16
Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
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 higher scores indicating more severe disease.
Measured: Week 52
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
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).
Measured: Week 52

Timeline

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

9 Jun 202120 Apr 2023

First posted1 Jun 2021
Study start9 Jun 2021
Primary completion20 Apr 2023
Study completion20 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 352 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04908475
Sponsor's protocol ID: M20-326
Other IDs: 2020-005512-21
Status last verified: Apr 2024
First submitted: 28 May 2021
Last updated: 30 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

Stein Gold LF, Bagel J, Tyring SK, Hong HC, Pavlovsky L, Vender R, Pinter A, Reich A, Drogaris L, Wu T, Patel M, Soliman AM, Photowala H, Stakias V, Richter S, Papp KA. Comparison of risankizumab and apremilast for the treatment of adults with moderate plaque psoriasis eligible for systemic therapy: results from a randomized, open-label, assessor-blinded phase IV study (IMMpulse). Br J Dermatol. 2023 Oct 25;189(5):540-552. doi: 10.1093/bjd/ljad252.
PubMed 37488811

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?

See locations

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Plaque Psoriasis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor-blinded Study of Risankizumab Compared to Apremilast for the Treatment of Adult Subjects With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy
ClinicalTrials.gov ID: NCT04908475
Acronym / sponsor ID: M20-326
Conditions: Psoriasis
Keywords: Psoriasis, Plaque Psoriasis, Risankizumab, ABBV-066, Skyrizi, Apremilast
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 352 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 9 Jun 2021 (actual)
Primary completion: 20 Apr 2023 (actual)
Study completion: 20 Apr 2023 (actual)
First posted: 1 Jun 2021 (actual)
Results: Posted 30 Apr 2024

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Risankizumab	Experimental	Drug: RisankizumabRisankizumab 150 mg as a single subcutaneous (SC) injection at at Baseline (Day 1) and Week 4 (Period A) and at Weeks 16, 28, and 40 (Period B).
Apremilast	Experimental	Drug: Risankizumab, Drug: ApremilastParticipants receive apremilast 30 mg orally twice daily (BID) in Period A and re-randomized to receive either risankizumab 150 mg as a single SC injection at Weeks 16, 20, 32 in Period B or apremilast 30 mg orally BID from Week 16 up to Week 52 in Period B. For those taking apremilast in Period B, non-responders at Week 28 and Week 40 will be offered to receive risankizumab as rescue medication.

Who may qualify

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

Key inclusion criteria (4 listed)

Candidates for systemic therapy with moderate chronic plaque psoriasis (PsO) (with or without psoriatic arthritis) at Screening and Baseline for at least 6 months prior to Baseline defined as:
Body Surface Area (BSA) >= 10% and <= 15%; and
Psoriasis Area and Severity Index (PASI) >= 12; and
Static Physician Global Assessment (sPGA) = 3 (moderate) based on a 5-point scale (0 to 4).

Key exclusion criteria (4 listed)

Participant has any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO).
History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.
History of active ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with the assessment of PsO (e.g., hyperkeratotic eczema).
Prior exposure to risankizumab or apremilast.

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, SkyriziSubcutaneous injection	Drug	Apremilast, Risankizumab
ApremilastAlso: OtezlaOral Tablets	Drug	Apremilast

Primary outcome

Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A)
Time frame: Week 16
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 higher scores indicating more severe disease.
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population at Week 16 (ITT_A)
Time frame: Week 16
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).
Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
Time frame: Week 52
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 higher scores indicating more severe disease.

3 secondary outcomes

Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A)
Time frame: Week 16
Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
Time frame: Week 52
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)
Time frame: Week 52

Results and safety

Results posted to the registry on 30 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Period A: APR	234	216
Periods A/B: RZB/RZB	118	118
Period B: APR/APR, NR	0	0
Period B: APR/RZB, NR	0	0
Period B: APR/APR, R	0	0
Period B: APR/RZB, R	0	0

Primary outcome: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_A)

Time frame: Week 16. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Period A: APR n = 234	Period A: RZB n = 118
Value	5.1 (2.3 to 8.0)	55.9 (47.0 to 64.9)

Period A: APR vs Period A: RZB: Adjusted Difference: 50.7 (95% CI 41.3 to 60.1), p < 0.001, Cochran-Mantel-Haenszel

Population analysed: ITT\_A Population: all participants randomized in Period A

Primary outcome: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population at Week 16 (ITT_A)

Time frame: Week 16. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Period A: APR n = 234	Period A: RZB n = 118
Value	18.4 (13.4 to 23.3)	75.4 (67.7 to 83.2)

Period A: APR vs Period A: RZB: Adjusted Difference: 56.8 (95% CI 47.7 to 66.0), p < 0.001, Cochran-Mantel-Haenszel

Population analysed: ITT\_A Population: all participants randomized in Period A.

Primary outcome: Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)

Time frame: Week 52. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Period B: APR/APR, NR n = 78	Period B: APR/RZB, NR n = 83
Value	2.6 (0.0 to 6.1)	72.3 (62.7 to 81.9)

Period B: APR/APR, NR vs Period B: APR/RZB, NR: Difference: 69.7 (95% CI 59.5 to 80.0), p < 0.001, Chi-squared

Population analysed: ITT\_B\_NR Population: participants randomized to APR at Baseline who failed to achieve PASI 75 at Week 16 and were re-randomized to APR or RZB in Period B.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All Cause Mortality: From enrollment up to end of study, for an overall median of 419.5 days. Adverse Events: From first dose of study drug through approximately 20 weeks (140 days) after administration of the last dose of RZB (i.e., Week 40 for participants originally randomized to RZB and Week 44 for participants switched from APR to RZB) or approximately 4 weeks (28 days) after the last dose of APR (i.e., Week 56 for participants who remain on the APR arm after re-randomization).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Period A: APR	4 of 234 (1.7%)	101 of 234 (43.2%)	0 of 234
Period A: RZB	1 of 118 (0.8%)	24 of 118 (20.3%)	0 of 118
Period B: RZB/RZB	8 of 116 (6.9%)	36 of 116 (31%)	0 of 116
Period B: APR/APR	2 of 97 (2.1%)	27 of 97 (27.8%)	0 of 97
Period B: APR/RZB	3 of 102 (2.9%)	31 of 102 (30.4%)	0 of 102
Period B: APR/APR/RZB	0 of 48 (0%)	15 of 48 (31.3%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37488811Stein Gold LF, Bagel J, Tyring SK, Hong HC, Pavlovsky L, Vender R, Pinter A, Reich A, Drogaris L, Wu T, Patel M, Soliman AM, Photowala H, Stakias V, Richter S, Papp KA. Comparison of risankizumab and apremilast for the treatment of adults with moderate plaque psoriasis eligible for systemic therapy: results from a randomized, open-label, assessor-blinded phase IV study (IMMpulse). Br J Dermatol. 2023 Oct 25;189(5):540-552. doi: 10.1093/bjd/ljad252.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, 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.

Related trials for Psoriasis

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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

54 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Risankizumab and Apremilast in people with Psoriasis, run by AbbVie at 54 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 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 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Canada, Germany, Poland, Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 30 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population at Week 16 (ITT_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 NCT04908475, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.