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Psoriasis (PsO)NCT06987292

A Prospective Study to Assess the Efficacy of IL-17 Inhibitors on Subclinical Enthesitis in Patients With Moderate to Severe Psoriasis Based on Power Doppler (PD) Ultrasonography (PDUS)

An observational study of Psoriasis (PsO) and Enthesitis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 2 sites in China.

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

It is an observational, single-center, prospective, exploratory, open-label study to assess the efficacy and safety of IL-17 inhibitors on subclinical enthesitis in patients with moderate to severe psoriasis with subclinical enthesitis based on Power Doppler (PD) Ultrasonography (PDUS) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis (PsO), Enthesitis, Psoriasis Arthritis
What is being tested?
IL-17i
How many people
50 participants
Where
2 sitesChina
Study dates
1 May 2025to 31 Dec 2027
Phase
Observational
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

Study population: Adult patients with moderate to severe plaque psoriasis

Who may be able to join

  • Adult patients ( ≥ 18 years of age) with chronic plaque-type psoriasis
  • Meet one of the following conditions: Psoriasis Area and Severity Index [PASI] score > 6, or scalp involvement, or nail involvement.
  • Inflammatory changes on ultrasound consistent with OMERACT definition at least at one peripheral attachment point at screening, defined as thickening and/or abnormal echogenicity of tendons or ligaments at the site of their insertion into the bone (within 2 mm of the talar cortex), and active Doppler signals that may indicate structural damage such as bone erosion, syndesmophytes/calcifications
  • Psoriasis is inadequately controlled by current topical therapy or phototherapy
  • Able to sign the informed consent

Who cannot join

  • Diagnosis of PsA2 according to CASPAR
  • Any known rheumatic disease, positive rheumatoid factor/anti-citrullinated protein antibodies, prior treatment with anti-rheumatic drugs
  • Treatment with systemic corticosteroids within 12 weeks or 5 half-lives of screening
  • Obesity impeded ultrasound examination
  • Pregnant or lactating women or women with plan for conception 5 months before or after treatment
  • Participated in other clinical trials
Show all 16Show fewer
  • Concurrent significant medical problems, including but not limited to the following: uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 95 mmHg), congestive heart failure (NYHA class III or IV), total white blood cell count < 2500/μl, or platelets < 100,000/μl or neutrophils < 1500/μl or hemoglobin < 8.5 g/dL at screening.
  • Any liver function abnormality: aspartate aminotransferase (AST) > 2xULN, alanine aminotransferase (ALT) > 2xULN, total bilirubin (TBIL) > 2xULN
  • Abnormal renal function: serum creatinine > 2.0 mg/dl
  • History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection, defined as a positive PPD skin test or Mycobacterium tuberculosis interferon-gamma release assay (IGRA) test.
  • Current or relevant history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.
  • History of lymphoproliferative disease, or any known malignancy, or history of malignancy of any organ system within the past 5 years
  • Unable or unwilling to undergo repeated venipuncture
  • History of alcohol or drug abuse or evidence of abuse within 6 months prior to baseline
  • History of hypersensitivity to any component of the study drug
  • Did not accept live vaccines within 4 weeks prior to enrollment, do not have plan of vaccination program during the study, and no live vaccines are planned > 6 months after the last dose of the study (herpes zoster vaccine > 12 months)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites, 2 recruiting
  • Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Recruiting
  • Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Wenjun HOU, Dr, +86 135 8402 3320, hwjnanjing@126.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy of IL-17 Inhibitors on Subclinical Enthesitis in Patients With Moderate to Severe Psoriasis Based on Power Doppler (PD) Ultrasonography (PDUS): a Single-center, Prospective, Exploratory, Open-label Study

It is an observational, single-center, prospective, exploratory, open-label study to assess the efficacy and safety of IL-17 inhibitors on subclinical enthesitis in patients with moderate to severe psoriasis with subclinical enthesitis based on Power Doppler (PD) Ultrasonography (PDUS)

Being tested
IL-17i
Medical subject headings
Psoriasis

What participants receive

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

  • IL-17iDrug

    IL-17 inhibitors

Study groups in NCT06987292
Study groupRoleWhat they receive
moderate to severe psoriasis with subclinical enthesitis based on PDUSNot described
Receives: Drug: IL-17i

What is being measured

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

  1. Change of Glasgow Ultrasound Enthesitis Scoring System (GUESS) from baseline to week 24

    Glasgow Ultrasound Enthesitis Scoring System (GUESS) is an ultrasonographic score of lower limb enthesitis including superior pole of the patella-quadriceps tendon enthesis, inferior pole of the patella-proximal patellar ligament enthesis, tibial tuberosity-distal patellar ligament enthesis, superior pole of the calcaneus-achilles tendon enthesis and inferior pole of the calcaneus-plantar aponeurosis enthesis, composed of assessments of degenerative changes such as tendon thickness, existence of enthesitis, bursitis, or erosions. It is calculated as follows: one point was scored for each abnormality at each site examined, giving a possible maximum total score for both lower extremities 36. A higher score of GUESS represents more serve inflammation and involvement of enthesis while a lower score represents better outcomes.

    Measured: Week 24

Secondary outcomes (14)
  1. Change of Glasgow Ultrasound Enthesitis Scoring System(GUESS) from baseline to week 4, 12, 36, 52

    Glasgow Ultrasound Enthesitis Scoring System (GUESS) is an ultrasonographic score of lower limb enthesitis including superior pole of the patella-quadriceps tendon enthesis, inferior pole of the patella-proximal patellar ligament enthesis, tibial tuberosity-distal patellar ligament enthesis, superior pole of the calcaneus-achilles tendon enthesis and inferior pole of the calcaneus-plantar aponeurosis enthesis, composed of assessments of degenerative changes such as tendon thickness, existence of enthesitis, bursitis, or erosions. It is calculated as follows: one point was scored for each abnormality at each site examined, giving a possible maximum total score for both lower extremities 36. A higher score of GUESS represents more serve inflammation and involvement of enthesis while a lower score represents better outcomes.

    Measured: Week 4, 12, 36, 52

  2. Complete resolution of enthesitis from baseline to week 24

    Complete resolution of enthesitis from baseline to week 24 based on enthesis assessed by GUESS. It means the percentage reaching a score of 0 for each enthesis. Higher percentage represents higher improvement.

    Measured: Week 24

  3. Complete resolution of enthesitis from baseline to week 52

    Complete resolution of enthesitis from baseline to week 52 based on enthesis assessed by GUESS. It means the percentage reaching a score of 0 for each enthesis. Higher percentage represents higher improvement.

    Measured: Week 52

  4. New bone erosion, bursitis, osteophytes at week 24

    New bone erosion, bursitis, osteophytes at week 24 based on enthesis assessed by GUESS. It means the percentage that the score changes from 0 to 1 in the item of 'erosion, bursitis, osteophytes' for each enthesis. Higher percentage represents more worsening of inflammation.

    Measured: Week 24

  5. New bone erosion, bursitis, osteophytes at week 52

    New bone erosion, bursitis, osteophytes at week 52 based on enthesis assessed by GUESS. It means the percentage that the score changes from 0 to 1 in the item of 'erosion, bursitis, osteophytes' for each enthesis. Higher percentage represents more worsening of inflammation.

    Measured: Week 52

  6. Change of patient pain assessment based on Visual Analog Scale (VAS) at week 4, 12, 24, 36, 52

    Change of patient pain assessment based on Visual Analog Scale (VAS) at week 4, 12, 24, 36, 52. The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors. For pain intensity, the scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 100 [100-mm scale]). Higher score represents more severe pain.

    Measured: Week 4, 12, 24, 36, 52

  7. Change of PASI from baseline to week 24, 52

    The Psoriasis Area and Severity Index Score (PASI) is a physician assessment that combines the assessment of the severity (erythema, induration and desquamation) of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease). The higher the score the more severe the psoriasis.

    Measured: Week 24, 52

  8. Change of BSA% from baseline to week 24, 52

    Body Surface Area (BSA) is a measure of how much skin is impacted by psoriasis and can be used to track an individual's psoriasis over time. For context, one handprint is equal to approximately 1 percent BSA. Involvement of <3% BSA is considered mild, 3%-10% BSA is considered moderate and >10% of BSA is considered severe psoriasis.

    Measured: Week 24, 52

  9. Change of mNAPSI from baseline to week 24, 52

    The mNAPSI is a tool for physicians to evaluate the severity of nail bed psoriasis and nail matrix psoriasis by area of involvement in the nail unit. Each fingernail is rated for the presence and severity of seven features to give a total fingernail score of 0-13 (0= no involvement, 13 = greatest involvement). The total mNAPSI score is the sum of the 10 fingernail scores (range 0-130; 0= no involvement, 130= greatest involvement). The higher the score the more severe the nail bed psoriasis.

    Measured: Week 24, 52

  10. Change of PSSI from baseline to week 24, 52

    The Psoriasis Scalp Severity Index scale (PSSI) rates psoriasis severity on the scalp based on three parameters: erythema (redness), scaling, and thickness. Each parameter is assessed individually, and the scores are combined to provide an overall severity rating. The total PSSI score is a sum of scores for erythema, induration, and desquamation x involved area, ranges 0 (no disease) to 72 (maximal disease). The higher the score the more severe the scalp psoriasis is.

    Measured: Week 24, 52

  11. Change of HAQ-DI from baseline to week 24, 52

    The HAQ-DI is scored on a four-level difficulty scale ranging from zero (normal, no difficulty) to three (unable to do, extreme difficulty). There are 20 questions covering eight domains: dressing, rising, eating, talking, hygiene, reach, grip, and usual activities. The highest score for an item within each domain is taken as the score for that domain; the HAQ-DI total score is the average of the eight domain scores and therefore ranges between 0 and 3. Scores of 0-1 represent mild to moderate difficulty; 1-2 represent moderate to severe disability; 2-3 represent severe to very severe disability.

    Measured: Week 24, 52

  12. Change of SJC66 and TJC68 from baseline to week 24, 52

    66/68 swollen and tender joint counts (SJC66/TJC68)

    Measured: Week 24, 52

  13. Change of SPARCC enthesitis index from baseline to week 24, 52

    Medial epicondyle (left/right (L/R)) Lateral epicondyle (L/R) Supraspinatus insertion into greater tuberosity of humerus (L/R) Greater trochanter (L/R) Quadriceps insertion into superior border of patella (L/R) Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R) Achilles tendon insertion into calcaneum (L/R) Plantar fascia insertion into calcaneum (L/R)

    Measured: Week 24, 52

  14. Proportion of patients who progressed to PsA at Week 52

    Proportion of patients who progressed to PsA at Week 52, based on CASPAR

    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 posted23 May 2025
  2. Study start1 May 2025
  3. Primary completion1 May 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06987292
Sponsor's protocol ID
2025-0301-02
Status last verified
May 2025
First submitted
5 May 2025
Last updated
23 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schett G, Rahman P, Ritchlin C, McInnes IB, Elewaut D, Scher JU. Psoriatic arthritis from a mechanistic perspective. Nat Rev Rheumatol. 2022 Jun;18(6):311-325. doi: 10.1038/s41584-022-00776-6. Epub 2022 May 5.

    PubMed 35513599
  • Chen R, Zhong X, Huang D, Chen Z, Yu Y, Lu J, Wang Q, Kong L, Yi X, Zhao Y, Ding Y, Guo L, Shi Y. Advantages of ultrasound imaging for the early diagnosis of psoriatic arthritis in patients with moderate to severe psoriasis. Heliyon. 2024 Jul 4;10(13):e34136. doi: 10.1016/j.heliyon.2024.e34136. eCollection 2024 Jul 15.

    PubMed 39055795
  • Weiner SM, Jurenz S, Uhl M, Lange-Nolde A, Warnatz K, Peter HH, Walker UA. Ultrasonography in the assessment of peripheral joint involvement in psoriatic arthritis : a comparison with radiography, MRI and scintigraphy. Clin Rheumatol. 2008 Aug;27(8):983-9. doi: 10.1007/s10067-008-0835-y. Epub 2008 Feb 8.

    PubMed 18259687
  • Balint PV, Kane D, Wilson H, McInnes IB, Sturrock RD. Ultrasonography of entheseal insertions in the lower limb in spondyloarthropathy. Ann Rheum Dis. 2002 Oct;61(10):905-10. doi: 10.1136/ard.61.10.905.

    PubMed 12228161

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriasis (PsO) and Enthesitis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 2 sites in China.

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 16 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 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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.

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 Wenjun Hou, Dr (+ 86 135 8402 3320, hwjnanjing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Glasgow Ultrasound Enthesitis Scoring System (GUESS) from baseline to week 24 (time frame: 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 NCT06987292, which also lists 4 linked publications.

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 23 May 2025.

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