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PsoriasisPhase 4PAMPANCT05004727

Multi-Center PAMPA Study

A Phase 4 study testing Guselkumab in people with Psoriasis, run by NYU Langone Health at 5 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a multi-center (North-America), randomized, double-blind, placebo-controlled, wait-list, interventional, preventive trial of guselkumab in high-risk psoriasis patients compared to non-biologic standard of care. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
Guselkumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
176 participants
Where
5 sitesin 2 countries
Study dates
16 Feb 2022to 2 Nov 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

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

  • 18 years old or older;
  • Both male \& female;
  • Psoriasis diagnosis (per dermatologist) for at least 2 years (in at least 30% of participants);
  • Willing and able to provide informed consent;
  • Fulfillment of HR-PsO criteria (Psoriasis (PsO) patients will meet the definition of HR if they fulfill the following criteria: a) PsO duration >2 years and Psoriasis Body Surface Area (BSA) >3% and positive imaging findings in MSKPDUS defined as a RM-PsASon score of >3.36

Who cannot join

  • Evidence of inflammatory joint pain, enthesitis and/or dactylitis on exam;
  • Current systemic immunosuppressive medication use (i.e., methotrexate, apremilast) at the time of enrollment or biologic therapy (ever);
  • RA seropositivity (mid-high RF/ACPA titers);
  • Current active malignancy;
  • History of symptomatic polyarticular OA or other joint conditions (such as RA, gout, etc) that may impair the ability to assess for PsA development
  • Conditions where initiation of guselkumab is prohibited in the prescribing information, including clinically important active infection and untreated latent tuberculosis;
  • Known hypersensitivity to the study agent.

Trial locations and contacts

5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Stephanie Eichman contact

Stephanie.Eichman@nyulangone.org

5 sites in 2 countries

United States3 sites, 3 recruiting
  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Jeffrey Sparks, MD

    Joseph Merola, MD, MMSc

    Recruiting
  • NYU Langone Health

    New York, New York, 10016

    Jose Scher, MD, Jose.Scher@nyulangone.org

    Stephanie Eichman, EdD, Stephanie.Eichman@nyulangone.org

    Recruiting
  • University of Rochester Medical Center (URMC)

    Rochester, New York, 14623

    Christopher Ritchlin, MD, MPH

    Christopher_Ritchlin@urmc.rochester.edu

    Recruiting

Other trials in United States

Canada2 sites, 2 recruiting
  • Memorial University

    St. John's, Newfoundland and Labrador, A1C 5B8

    Wayne Gulliver, MD, drgulliver@newlabresearch.com

    Proton Rahman, MD

    Recruiting
  • Women's College Research Institute, University of Toronto

    Toronto, Ontario, M5S 1B2

    Lihi Eder, MD PhD, lihi.eder@wchospital.ca

    Lihi Eder, MD PhD

    Recruiting

Other trials in Canada

About this study

Official title: Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort

This is a multi-center (North-America), randomized, double-blind, placebo-controlled, wait-list, interventional, preventive trial of guselkumab in high-risk psoriasis patients compared to non-biologic standard of care.

The primary objective of the proposed trial will be to test the hypothesis that a prolonged, unresolved skin inflammation coupled with musculoskeletal power-doppler ultrasound (MSKPDUS) abnormalities driven by IL-23 increase the risk for transition into PsA and that an intervention that targets one of these pivotal molecules (i.e., Guselkumab) will:

  1. Diminish MSKPDUS findings at 24 weeks, and
  2. Significantly reduce or prevent the emergence of synovio-enthesial phenotype at year 2.
Conditions
Psoriasis
Being tested
Guselkumab, Placebo
Medical subject headings
Psoriasis

What participants receive

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

  • GuselkumabDrug

    Guselkumab 100 mg 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (month 0 to month 24 for arm 1; week 24 to month 24 for arm 2).

  • PlaceboDrug

    • Placebo to Guselkumab 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (Month 0 to Week 20 for Arm 2).
Study groups in NCT05004727
Study groupRoleWhat they receive
Guselkumab + Topicals (GUS)ExperimentalNot described
Receives: Drug: Guselkumab
Placebo + Topicals (PBO)Placebo comparatorNot described
Receives: Drug: Guselkumab; Drug: Placebo
Standard-of-Care Therapy (SOC)No interventionIn this third, non-randomized arm, patients would continue treatment with topical therapy or UVB, as part of our ongoing natural history of disease registries. This arm will include participants fulfilling RM-PsASon criteria but also those that do not (to serve as "negative" controls).

What is being measured

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

  1. Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score

    Score is defined by the ultrasound (General Electric Logiq E9 or E10) equipment, not calculated through a scale.

    Measured: Baseline, Week 24

Secondary outcomes (13)
  1. Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 2

    To meet CASPAR criteria for diagnosis of PsA, a participant must have inflammatory articular disease (joint, spine, entheseal or dactyitic) and at least 3 points from the following:

    1. Evidence of current psoriasis (2pts), personal history of psoriasis (2pts), family history (1pt)
    2. Typical psoriatic nail dystrophy including onycholysis, pitting, and hyperkeratosis observed on current physical examination (1pt)
    3. A negative test result for the presence of rheumatoid factor by any method except latex (1pt)
    4. Either current dactylitis, defined as swelling of an entire digit, or a history of dactylitis recorded by a rheumatologist (1pt)
    5. Radiographic evidence of juxta-articular new bone formation appearing as ill-defined ossification near joint margins (but excluding osteophyte formation) on plain radiographs of the hand or foot (1pt) The eCRF will autopopulate the total number of points. If the total score ≥ 3, the participant meets criteria for PsA diagnosis.

    Measured: Year 2

  2. Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 1

    To meet CASPAR criteria for diagnosis of PsA, a participant must have inflammatory articular disease (joint, spine, entheseal or dactyitic) and at least 3 points from the following:

    1. Evidence of current psoriasis (2pts), personal history of psoriasis (2pts), family history (1pt)
    2. Typical psoriatic nail dystrophy including onycholysis, pitting, and hyperkeratosis observed on current physical examination (1pt)
    3. A negative test result for the presence of rheumatoid factor by any method except latex (1pt)
    4. Either current dactylitis, defined as swelling of an entire digit, or a history of dactylitis recorded by a rheumatologist (1pt)
    5. Radiographic evidence of juxta-articular new bone formation appearing as ill-defined ossification near joint margins (but excluding osteophyte formation) on plain radiographs of the hand or foot (1pt) The eCRF will autopopulate the total number of points. If the total score ≥ 3, the participant meets criteria for PsA diagnosis.

    Measured: Year 1

  3. Severity of PsA at the time of synovio-entheseal development

    Severity will be categorized as mild, moderate, or severe.

    Measured: Year 2

  4. Change in the ultrasound composite score of synovitis

    Graded from 0-3 as absent, mild, moderate or severe according to images of a reference atlas (Hammer HB 2011). PD signal: 0=no PD-signal, 1=up to three single or two confluent signals, 2=less than half of the visible intracapsular area and 3=half or more of the visible intracapsular area covered by PD-signals.

    Measured: Baseline, week 24

  5. Change in Madrid Sonographic Enthesis Index (MASEI) Score

    MASEI: Structure is considered pathological (score=1) if there is a loss of fibrillar pattern, hypoechoic aspect, or fusiform thickening of the entheses. Erosions are defined as a cortical breakage with a step-down contour defect at the attachment of entheses at bone and graded with 0=absent or 3=present. Fascia and tendon thickness are measured at the point of maximal thickness on the bony insertion and graded with 0=normal or 1=thickened according to the reference values of the MASEI index. Enthesophytes are defined as calcifications at the entheses insertions into bone and graded with 0=absent, 1=small calcification, 2=clear presence of enthesophyte/calcification, 3= large calcifications or ossifications. PD-signals within entheses are scored with 0=absent or 3=present. Bursitis is investigated at the level of distal patellar tendon (infrapatellar bursitis) and the level of Achilles tendon insertion (retrocalcaneal bursitis) and graded with 0=absent and 1=present.

    Measured: Baseline, week 24

  6. Psoriasis Body Surface Area (BSA)

    The total BSA affected by plaque-type psoriasis will be estimated from the percentages of areas affected, including head, trunk, upper limbs and lower limbs. The following calculations will be done: each reported percentage will be multiplied by its respective body region corresponding factor (head = 0.1, trunk = 0.3, upper limbs = 0.2, lower limbs = 0.4). The resulting four percentages will be added up to estimate the total BSA affected by psoriasis.

    Measured: Week 24

  7. Achieved IGA mod 2011 Score

    Score 0 - Clear - No signs of psoriasis. Post-inflammatory hyperpigmentation may be present Score 1 - Almost clear - Normal to pink coloration of lesions; no thickening; no to minimal focal scaling Score 2 - Mild disease - Pink to light red coloration; just detectable to mild thickening; predominantly fine scaling Score 3 - Moderate disease - Dull bright red, clearly distinguishable erythema; clearly distinguishable to moderate thickening; moderate scaling Score 4 - Severe disease - Bright to deep dark red coloration; severe thickening with hard edges; severe / coarse scaling covering almost all or all lesions

    Measured: Week 24

  8. Change in Functional Assessment of Chronic Illness Therapy (FACIT) Scale

    FACIT consists of 13 statements regarding fatigue (e.g., "I feel fatigued", "I feel weak all over", "I feel tired", etc.). Items are scored as follows: 4=not at all, 3=a little bit, 2=somewhat, 1=quite a bit; 0=very much, EXCEPT items #7 and 8 which are reversed scored. Total score range is 0-52. A score of less than 30 indicates severe fatigue. The higher the score, the better the quality of life.

    Measured: Week 24

  9. Change in EuroQol-5D (EQ-5D) Score

    The scale measures how good or bad one's health is on the day of the questionnaire. Total score is 0-100; the higher the score, the better the health (0 = worst health one can imagine, 100 = best health one can imagine)

    Measured: Baseline, Week 24

  10. Change in EuroQol-5D (EQ-5D) Score

    The scale measures how good or bad one's health is on the day of the questionnaire. Total score is 0-100; the higher the score, the better the health (0 = worst health one can imagine, 100 = best health one can imagine)

    Measured: Baseline, Year 2

  11. Change in International Dermatology Outcome Measures - Musculoskeletal -8 (IDEOM-MSK-8) Score

    IDEOM-MSK-8 is a short questionnaire that allows people with MSK conditions to report their symptoms and quality of life in a standardized way. The total range of score is 0-56; the higher the score, the better the MSK health status. In order to calculate the total score, the numbers next to the boxes that the participant has ticked on the questionnaire form is added up.

    Measured: Baseline, Week 24

  12. Change in Ultrasound (US) Score

    Score is defined by the ultrasound (General Electric Logiq E9 or E10) equipment, not calculated through a scale.

    Measured: Baseline, Week 24

  13. Proportion of participants who achieved ≥ 50% improvement in US score at 24 weeks

    Assessed using ultrasound results.

    Measured: Up to Week 24

Timeline

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

  1. First posted13 Aug 2021
  2. Study start16 Feb 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion2 Nov 2028 (estimated)

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05004727
Sponsor's protocol ID
20-01158
Acronym
PAMPA
Status last verified
Mar 2026
First submitted
6 Aug 2021
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

Publications

  • Haberman RH, MacFarlane KA, Catron S, Samuels J, Blank RB, Toprover M, Uddin Z, Hu J, Castillo R, Gong C, Qian K, Piguet V, Tausk F, Yeung J, Neimann AL, Gulliver W, Thiele RG, Merola JF, Ogdie A, Rahman P, Chakravarty SD, Eder L, Ritchlin CT, Scher JU. Efficacy of guselkumab, a selective IL-23 inhibitor, in Preventing Arthritis in a Multicentre Psoriasis At-Risk cohort (PAMPA): protocol of a randomised, double-blind, placebo controlled multicentre trial. BMJ Open. 2022 Dec 23;12(12):e063650. doi: 10.1136/bmjopen-2022-063650.

    PubMed 36564123

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Guselkumab in people with Psoriasis, run by NYU Langone Health at 5 sites in 2 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Canada. 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 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Jose Scher, MD (6465017400, Jose.Scher@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score (time frame: Baseline, Week 24). 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 NCT05004727, 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 Mar 2026.

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