ClinicalTrials.gg
Active, not recruitingNCT07321873VELOTAUpdated Nov 3, 2026

A Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic Arthritis

A Phase 2 interventional study of JNJ-88545223 and Placebo in Arthritis, Psoriatic, sponsored by Janssen Research & Development, LLC. Active, not recruiting at 75 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment

Updated Nov 3, 2026Now Active, not recruitingEnrollment updated+1 moreGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
157
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 37 studies in Arthritis, Psoriatic by Johnson & Johnson — 5 open to participants now, 13 under way, 5 of them phase 3. Arthritis, Psoriatic · Johnson & Johnson.

Enrollment
15th of 25
157 · median 196
Started
2026
with 2 others
Phase 2
4 of 37
none open now
Primary completion
2027-06
later than 4 of 12 live
Registered
35th of 37
by date

Among the 37 studies in Arthritis, Psoriatic by Johnson & Johnson, this one is the 15th largest by enrollment of the 25 interventional ones that give a count, is one of 3 that started in 2026, is one of 4 in phase 2, reaches primary completion later than 4 of the 12 other live ones, and was the 35th registered.

Arthritis, Psoriatic

600 studies on the registry are indexed under Arthritis, Psoriatic; 128 are open to participants now.

Browse Arthritis, Psoriatic studies →

Open to participants now

5 of the 37 studies in Arthritis, Psoriatic by Johnson & Johnson are open now, in 12 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Who these studies take

Of the 88 Arthritis, Psoriatic studies recruiting now, 53 (60%) set no upper age limit and 26 (30%) stop at 75 or younger; 12 take children under 18; 12 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 37 studies in Arthritis, Psoriatic by Johnson & Johnson, or all of them as a file.
02

Study summary

The purpose of this study is to evaluate how well the study drug JNJ-88545223 works compared with a placebo (an inactive substance) in adults with active psoriatic arthritis (PsA). The study aims to see whether treatment with JNJ-88545223 can help reduce the signs and symptoms of PsA and improve joint and skin health.

03

Conditions studied

  • Arthritis, Psoriatic

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening
  • Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (Week 0/Day 1) based on the 66/68 joint assessment; AND (b) C-reactive protein (CRP) greater than or equal to (>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory
  • Have >= 1 of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
  • Have active plaque psoriasis with at least one psoriatic plaque of >= 2 centimeter (cm) diameter or nail changes consistent with psoriasis
  • A female participant of must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention

Exclusion criteria

Exclusion Criteria:

  • Has a nonplaque form of psoriasis (for example, erythrodermic, guttate, or pustular)
  • Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (except PsA), psychiatric, genitourinary, or metabolic disturbances
  • Has suspected or known allergies, , or intolerance to JNJ-88545223 or used in the medicinal product (IMP), including placebo (JNJ-88545223 investigator's brochure); or has a history of severe allergic reaction, angioedema, or anaphylaxis to drugs or food
  • Has fibromyalgia or osteoarthritis symptoms that, in the opinion of the investigator, would have potential to interfere with efficacy assessments
  • Currently has a or has a history of malignancy within 5 years prior to screening
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
157 participants (actual)

Study arms

  • Placebo comparator
    Arm 1: Placebo

    Participants will receive matching placebo to JNJ-88545223, from Week 0 to Week 16.

    Drug: Placebo

  • Experimental
    Arm 2: JNJ-88545223 Dose 1

    Participants will receive JNJ-88545223 Dose 1 from Week 0 to Week 16.

    Drug: JNJ-88545223

  • Experimental
    Arm 3: JNJ-88545223 Dose 2

    Participants will receive JNJ-88545223 Dose 2 from Week 0 to Week 16.

    Drug: JNJ-88545223

  • Experimental
    Arm 4: JNJ-88545223 Dose 3

    Participants will receive JNJ-88545223 Dose 3 from Week 0 to Week 16.

    Drug: JNJ-88545223

Interventions

  • DrugJNJ-88545223

    JNJ-88545223 will be administered.

  • DrugPlacebo

    Placebo will be administered.

06

What researchers measure

Primary outcomes

  1. Proportion of Participants who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16

    The ACR 50 responders are participants with an improvement of greater than or equal to (\>=) 50 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale \[VAS\], patient's global assessment of disease activity \[arthritis, VAS\] scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).

    Time frame: Week 16

Secondary outcomes

  1. Proportion of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than or Equal to (>=) 3 Percent (%)

    A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.

    Time frame: Week 16

  2. Proportion of Participants Who Achieved PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3%

    A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.

    Time frame: Week 16

  3. Proportion of Participants Who Achieved PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3%

    A PASI 100 response represents participants who achieved at least a 100 percent improvement from baseline in the PASI score. The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.

    Time frame: Week 16

  4. Proportion of Participants who Achieved an ACR 20 Response at Week 16

    The ACR 20 responders are participants with an improvement of \>= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity \[arthritis, VAS\] scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).

    Time frame: Week 16

  5. Proportion of Participants who Achieved an ACR 70 Response at Week 16

    The ACR 70 responders are participants with an improvement of \>= 70% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity \[arthritis, VAS\] scale, Physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).

    Time frame: Week 16

  6. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16

    The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

    Time frame: Baseline up to Week 16

  7. Change From Baseline in 36 Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16

    SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0 to 100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).

    Time frame: Baseline up to Week 16

Other outcomes

  1. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important.

    Time frame: Up to Week 20

  2. Number of Participants With Change from Baseline in the Laboratory Parameters

    Participants with change from baseline in the laboratory parameters (hematology and serum chemistry) will be reported.

    Time frame: Baseline up to Week 20

07

Study locations

75 sites
08

References and documents

Individual participant data

Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Data sharing details ↗ · www.jnj.com

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Jun 2027, 17 months after the start.

Of 34 phase 2 interventional studies under Arthritis, Psoriatic, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 31. This study's planned 17 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 5, 2026
First posted
Jan 7, 2026
StartActual
Jan 15, 2026
Primary completionEst.
Jun 28, 2027
CompletionEst.
Aug 2, 2027
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Nov 3, 2026
Sites
2 sites added
Show 2 added (2 United States)
  • Clinical Research of West Florida 1 · Clearwater, United States
  • Onsite Clinical Solutions · Salisbury, United States
Sep 25, 2026
Enrollment
240 (estimated)→157 (actual)
Nov 3, 2026
Show all 2 updates
  1. Nov 3, 2026
    Recruiting→Active, not recruiting
    Enrollment 240 (estimated)→157 (actual)
    + 3 other changes: verification date, contact details and site details
  2. Sep 25, 2026
    2 sites added
    Show 2 added (2 United States)
    • Clinical Research of West Florida 1 · Clearwater, United States
    • Onsite Clinical Solutions · Salisbury, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07321873
Responsible party
Sponsor
First posted
Jan 7, 2026
Start date
Jan 15, 2026
Primary completion
Jun 28, 2027 (estimated)
Completion
Aug 2, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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