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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.

Official record
Search all trials

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
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.

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

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. Adverse events and change in disease symptoms will be monitored.

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.

Read more

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 groupRoleWhat they receive
RisankizumabExperimentalRisankizumab 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
ApremilastExperimentalParticipants 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.

  1. 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

  2. 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

  3. 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)

  1. 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

  2. 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

  3. 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.

  1. First posted1 Jun 2021
  2. Study start9 Jun 2021
  3. Primary completion20 Apr 2023
  4. Study completion20 Apr 2023

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 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
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

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.

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