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.
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
5 sites in 2 countries
United States3 sites, 3 recruiting
- 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
Canada2 sites, 2 recruiting
- 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
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:
- Diminish MSKPDUS findings at 24 weeks, and
- 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 group | Role | What they receive |
|---|---|---|
| Guselkumab + Topicals (GUS) | Experimental | Not described Receives: Drug: Guselkumab |
| Placebo + Topicals (PBO) | Placebo comparator | Not described Receives: Drug: Guselkumab; Drug: Placebo |
| Standard-of-Care Therapy (SOC) | No intervention | In 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.
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)
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:
- Evidence of current psoriasis (2pts), personal history of psoriasis (2pts), family history (1pt)
- Typical psoriatic nail dystrophy including onycholysis, pitting, and hyperkeratosis observed on current physical examination (1pt)
- A negative test result for the presence of rheumatoid factor by any method except latex (1pt)
- Either current dactylitis, defined as swelling of an entire digit, or a history of dactylitis recorded by a rheumatologist (1pt)
- 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
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:
- Evidence of current psoriasis (2pts), personal history of psoriasis (2pts), family history (1pt)
- Typical psoriatic nail dystrophy including onycholysis, pitting, and hyperkeratosis observed on current physical examination (1pt)
- A negative test result for the presence of rheumatoid factor by any method except latex (1pt)
- Either current dactylitis, defined as swelling of an entire digit, or a history of dactylitis recorded by a rheumatologist (1pt)
- 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
Severity of PsA at the time of synovio-entheseal development
Severity will be categorized as mild, moderate, or severe.
Measured: Year 2
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
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
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
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
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
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
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
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
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
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.
- First posted13 Aug 2021
- Study start16 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion2 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 NYU Langone HealthThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- Jose Scher, MD, Principal investigator, NYU Langone Health
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort
- ClinicalTrials.gov ID
- NCT05004727
- Acronym / sponsor ID
- PAMPA / 20-01158
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 2 Nov 2028 (estimated)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Diminish MSKPDUS findings at 24 weeks, and
- Significantly reduce or prevent the emergence of synovio-enthesial phenotype at year 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guselkumab + Topicals (GUS) | Experimental | Drug: Guselkumab |
| Placebo + Topicals (PBO) | Placebo comparator | Drug: Guselkumab, Drug: Placebo |
| Standard-of-Care Therapy (SOC) | No intervention | –In 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| GuselkumabGuselkumab 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). | Drug | Guselkumab + Topicals (GUS), Placebo + Topicals (PBO) |
| Placebo• 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). | Drug | Placebo + Topicals (PBO) |
Primary outcome
Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score
Time frame: Baseline, Week 24
Score is defined by the ultrasound (General Electric Logiq E9 or E10) equipment, not calculated through a scale.
13 secondary outcomes
Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 2
Time frame: Year 2
Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 1
Time frame: Year 1
Severity of PsA at the time of synovio-entheseal development
Time frame: Year 2
Change in the ultrasound composite score of synovitis
Time frame: Baseline, week 24
Change in Madrid Sonographic Enthesis Index (MASEI) Score
Time frame: Baseline, week 24
Psoriasis Body Surface Area (BSA)
Time frame: Week 24
Achieved IGA mod 2011 Score
Time frame: Week 24
Change in Functional Assessment of Chronic Illness Therapy (FACIT) Scale
Time frame: Week 24
Change in EuroQol-5D (EQ-5D) Score
Time frame: Baseline, Week 24
Change in EuroQol-5D (EQ-5D) Score
Time frame: Baseline, Year 2
Change in International Dermatology Outcome Measures - Musculoskeletal -8 (IDEOM-MSK-8) Score
Time frame: Baseline, Week 24
Change in Ultrasound (US) Score
Time frame: Baseline, Week 24
Proportion of participants who achieved ≥ 50% improvement in US score at 24 weeks
Time frame: Up to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Derived from this study: PubMed 36564123Haberman 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.
- Individual participant dataSharing planned: 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.
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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.
Stephanie Eichman contact
Jose Scher, MD principal investigator
NYU Langone Health
5 sites in 2 countries: see every site and its status.
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.