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)

NCT06987292 | Recruiting

• 1 other identifier: 2025-0301-02
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Psoriasis (PsO); Enthesitis; Psoriasis Arthritis; Secukinumab

Outcome Measures

Primary Outcomes (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.

  Week 24

Secondary Outcomes (14)

• Change of Glasgow Ultrasound Enthesitis Scoring System(GUESS) from baseline to week 4, 12, 36, 52

  Week 4, 12, 36, 52

• Complete resolution of enthesitis from baseline to week 24

  Week 24

• Complete resolution of enthesitis from baseline to week 52

  Week 52

• New bone erosion, bursitis, osteophytes at week 24

  Week 24

• New bone erosion, bursitis, osteophytes at week 52

  Week 52

Other Outcomes (2)

• Risk factors at baseline contributing to PsA development

  Week 52

• Association of risk factors with the development of PsA

  Week 52

Study Arms (1)

moderate to severe psoriasis with subclinical enthesitis based on PDUS

Drug: IL-17i

Interventions

IL-17i DRUG

IL-17 inhibitors

moderate to severe psoriasis with subclinical enthesitis based on PDUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with moderate to severe plaque psoriasis

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (2)

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

Nanjing, Jiangsu, 210008, China

RECRUITING

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

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 35513599 BACKGROUND

• 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.

  PMID: 39055795 BACKGROUND

• 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.

  PMID: 18259687 BACKGROUND

• 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.

  PMID: 12228161 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Wenjun Hou, Dr

CONTACT

+ 86 135 8402 3320; hwjnanjing@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Wenjun HOU

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 23, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)