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PsoriasisPhase 3IMMprintNCT04713592

Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement

A Phase 3 study testing Risankizumab in people with Psoriasis, run by AbbVie at 55 sites in 4 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

Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
174 participants
Where
55 sitesin 4 countries
Study dates
26 Feb 2021to 20 Apr 2023
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

  • Diagnosis of chronic palmoplantar plaque psoriasis (PPPsO) (with or without psoriatic arthritis) for at least 6 months before Baseline and a Palmoplantar Investigator's Global Assessment (ppIGA) of moderate or severe, at Screening and Baseline.
  • Must have at Screening and Baseline a plaque psoriasis (PsO) body surface area (BSA) involvement of greater than or equal to one percent, an Static Physician's Global Assessment (sPGA) score of moderate to severe (greater than or equal to three), a PPASI moderate to severe (greater than or equal to eight), at least one additional PsO plaque outside of the palms and soles.
  • Must be a candidate for systemic therapy as assessed by the investigator.
  • Previously had inadequately controlled disease by topicals, phototherapy and/or systemic treatments.

Who cannot join

  • History of PsO other than chronic plaque type PsO
  • History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.
  • Ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with PsO assessments.
  • Evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV), Active tuberculosis, Active systemic infection/clinically important infections in the last two weeks prior to Baseline.
  • Prior exposure to risankizumab.

Trial locations and contacts

55 sites in 4 countries.

55 sites in 4 countries

United States34 sites

  • Hamilton Research, LLC /ID# 219224

    Alpharetta, Georgia, 30022

  • David Fivenson, MD, PLC /ID# 219180

    Ann Arbor, Michigan, 48103

  • Colorado Center for Dermatology, PLLC /ID# 219223

    Centennial, Colorado, 80111-1724

  • ClinOhio Research Services /ID# 222298

    Columbus, Ohio, 43213-4440

  • Menter Dermatology Res Inst /ID# 219161

    Dallas, Texas, 75246

  • Henry Ford Medical Center /ID# 219205

    Detroit, Michigan, 48202-3046

  • Velocity Clinical Research-Providence /ID# 223350

    East Greenwich, Rhode Island, 02818

  • Psoriasis Treatment Center of Central New Jersey /ID# 219201

    East Windsor, New Jersey, 08520

  • Palmetto Clinical Trial Services /ID# 222275

    Fountain Inn, South Carolina, 29644-1928

  • Palmetto Clinical Trial Services /ID# 222299

    Fountain Inn, South Carolina, 29644-1928

  • Advanced Research Associates - Glendale /ID# 219197

    Glendale, Arizona, 85308

  • Skin Care Research - Hollywood /ID# 219184

    Hollywood, Florida, 33021-6748

  • Burke Pharmaceutical Research /ID# 223349

    Hot Springs, Arkansas, 71913-6404

  • Center for Clinical Studies - Houston (Binz) /ID# 219221

    Houston, Texas, 77004-8097

  • Dawes Fretzin, LLC /ID# 219219

    Indianapolis, Indiana, 46256

  • Forest Hills Dermatology Group /ID# 219200

    Kew Gardens, New York, 11415

  • Dermatology Research Associates /ID# 219195

    Los Angeles, California, 90045

  • GSI Clinical Research, LLC /ID# 219175

    Margate, Florida, 33063

  • Allcutis Research LLC /ID# 222272

    Methuen, Massachusetts, 01844-5864

  • Savin Medical Group, LLC /ID# 227754

    Miami Lakes, Florida, 33014-2490

  • International Clinical Research - Tennessee LLC /ID# 220930

    Murfreesboro, Tennessee, 37130-2450

  • The Dermatology Center PSC - New Albany /ID# 219183

    New Albany, Indiana, 47150

  • Icahn School of Medicine at Mount Sinai /ID# 219206

    New York, New York, 10029-6504

  • Virginia Clinical Research, Inc. /ID# 219181

    Norfolk, Virginia, 23507

  • Advanced Dermatology of the Midlands /ID# 219207

    Omaha, Nebraska, 68144-1105

  • Epiphany Dermatology of Kansas LLC /ID# 219208

    Overland Park, Kansas, 66210

  • University of Pittsburgh MC /ID# 219203

    Pittsburgh, Pennsylvania, 15260

  • NW Arkansas Clinical Trials Center /ID# 231602

    Rogers, Arkansas, 72758

  • Arlington Dermatology /ID# 219211

    Rolling Meadows, Illinois, 60008

  • Integrative Skin Science and Research /ID# 219216

    Sacramento, California, 95815

  • Advanced Clinical Research - Woseth Dermatology /ID# 224750

    Salt Lake City, Utah, 84117-4209

  • Medderm Associates /ID# 219210

    San Diego, California, 92103

  • Northshore University Health System Dermatology Clinical Trials Unit /ID# 219220

    Skokie, Illinois, 60077

  • Lenus Research & Medical Group /ID# 219202

    Sweetwater, Florida, 33172

Other trials in United States

Canada8 sites

  • Beacon Dermatology Inc /ID# 220940

    Calgary, Alberta, T3E 0B2

  • Dr. Irina Turchin PC Inc. /ID# 220938

    Fredericton, New Brunswick, E3B 1G9

  • Innovaderm Research Inc. /ID# 222126

    Montreal, Quebec, H2X 2V1

  • Dr. S.K. Siddha Medicine Professional Corporation /ID# 220936

    Newmarket, Ontario, L3Y 5G8

  • Centre de Recherche dermatologique du Quebec Metropolitain /ID# 220935

    Québec, Quebec, G1V 4X7

  • NewLab Clinical Research Inc. /ID# 220934

    St. John's, Newfoundland and Labrador, A1C 2H5

  • Dr. Chih-ho Hong Medical Inc. /ID# 220941

    Surrey, British Columbia, V3R 6A7

  • Research Toronto /ID# 220939

    Toronto, Ontario, M4W 2N4

Other trials in Canada

Spain8 sites

  • Hospital Universitario Basurto /ID# 220904

    Bilbao, Vizcaya, 48013

  • Hospital Universitario de la Princesa /ID# 224911

    Madrid, 28006

  • Hospital Universitario Ramon y Cajal /ID# 220908

    Madrid, 28034

  • Hospital Regional Universitario de Malaga /ID# 220900

    Málaga, 29011

  • Hospital Universitario Virgen del Rocio /ID# 220907

    Seville, 41013

  • Hospital General Universitario de Valencia /ID# 220898

    Valencia, 46014

  • Hospital Universitario y Politecnico La Fe /ID# 220903

    Valencia, 46026

  • Hospital Clinico Universitario Lozano Blesa /ID# 222492

    Zaragoza, 50009

Other trials in Spain

Puerto Rico5 sites

  • Dr. Samuel Sanchez PSC /ID# 218789

    Caguas, 00727

  • Alma M. Cruz Santana, MD-Private practice /ID# 218790

    Carolina, 00985

  • Pan American Center for Oncology Trials, LLC /ID# 218788

    Rio Piedras, 00935

  • Clinical Research Puerto Rico /ID# 218787

    San Juan, 00909

  • GCM Medical Group, PSC /ID# 218786

    San Juan, 00917

Other trials in Puerto Rico

About this study

Official title: IMMprint: A Phase 3b Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating Safety and Efficacy of Risankizumab Compared to Placebo in Adult Subjects With Moderate to Severe Plaque Psoriasis With Palmoplantar (Non-Pustular) Involvement (PPPsO)

Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. Palmoplantar (non-pustular) plaque psoriasis (PPPsO) represents a localized form of psoriasis in palms and soles. This study will evaluate how safe risankizumab is for the treatment of plaque psoriasis with palmoplantar involvement and to assess change in disease symptoms.

Risankizumab is an approved drug for the treatment of psoriasis. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo in Period A. In Period B, all the participants will receive risankizumab. Around 168 adult participants with a moderate to severe plaque psoriasis will be enrolled in approximately 55 sites across the world.

Read more

Participants will receive single subcutaneous (administered under the skin) risankizumab or placebo in period A (16 weeks). In period B (36 weeks), all participants will receive subcutaneous risankizumab once every 12 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Conditions
Psoriasis
Being tested
Placebo for Risankizumab, Risankizumab
Keywords
Psoriasis, Plaque Psoriasis, Moderate to Severe Plaque Psoriasis, Plaque Psoriasis with Palmoplantar (Non-Pustular) Involvement (PPPsO), Risankizumab, SKYRIZI, ABBV-066
Medical subject headings
Psoriasis, Margins of Excision

What participants receive

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

  • Placebo for RisankizumabDrug

    Subcutaneous (SC) Injection

  • RisankizumabDrug

    Also called ABBV-066, SKYRIZI

    Subcutaneous (SC) Injection

Study groups in NCT04713592
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.
Receives: Drug: Placebo for Risankizumab; Drug: Risankizumab
RisankizumabExperimentalParticipants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.
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 Palmoplantar Investigator's Global Assessment (ppIGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16

    The ppIGA is a 5-point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), and scaling of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being "clear" and 1 being "almost clear."

    Measured: Baseline, Week 16

  2. Number of Participants With Treatment-Emergent Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

    Measured: From the first dose of study drug in the Double-blind Period up to 140 days after the last dose; from the first dose of study drug in the Open-label Period up to 140 days after the last dose and the end of study date (up to 60 weeks)

Secondary outcomes (4)

  1. Percentage of Participants Achieving ≥ 75% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 75) Response at Week 16

    PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease.

    Measured: Baseline, Week 16

  2. Percentage of Participants Achieving ≥ 90% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 90) Response at Week 16

    PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease.

    Measured: Baseline, Week 16

  3. Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16

    sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Higher scores indicate more severe disease.

    Measured: Baseline, Week 16

  4. Percentage of Participants Achieving 100% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 100) Response at Week 16

    PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease.

    Measured: Baseline, Week 16

Timeline

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

  1. First posted19 Jan 2021
  2. Study start26 Feb 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04713592
Sponsor's protocol ID
M15-994
Other IDs
2020-000581-42
Acronym
IMMprint
Status last verified
Jun 2024
First submitted
13 Jan 2021
Last updated
14 Jun 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

  • Lebwohl M, Bukhalo M, Stein Gold L, Glick B, Llamas-Velasco M, Sanchez-Rivera S, Pan A, Zhan T, Drogaris L, Douglas K, St John G, Espaillat R, Bissonnette R. A randomized phase 3b study evaluating the safety and efficacy of risankizumab in adult patients with moderate-to-severe plaque psoriasis with non-pustular palmoplantar involvement. J Am Acad Dermatol. 2024 Dec;91(6):1150-1157. doi: 10.1016/j.jaad.2024.07.1521. Epub 2024 Aug 30.

    PubMed 39208985

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Risankizumab in people with Psoriasis, run by AbbVie at 55 sites in 4 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 5 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 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Canada, Spain, Puerto Rico. 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. Some participants in this study may receive a placebo. 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 14 Jun 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 Palmoplantar Investigator's Global Assessment (ppIGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16 (time frame: Baseline, Week 16). The study lists 2 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 NCT04713592, 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 14 Jun 2024.

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