Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo- and Comparator-controlled, Multicenter, Phase 2 Trial to Assess the Efficacy and Safety of HS-10374 in Adults With Active Psoriatic Arthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06176508
• Other study ID #: HS-10374-202
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 5, 2024
• Est. completion date: August 28, 2026

Study information

• Verified date: December 2023
• Source: Hansoh BioMedical R&D Company
• Contact: Hejian Zou, PhD
• Phone: +86-13311881366
• Email: hjzou[@]unirheuma.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of active psoriatic arthritis. Additionally, this study is to find the optimal dosing for the future clinical development of HS-10374.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: August 28, 2026
• Est. primary completion date: April 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female subjects between the ages of 18-75 years.

2. Has a history of psoriatic arthritis (PsA) for at least 6 months, and meets the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening.

3. Active arthritis as shown = 3 swollen joints (66 joints) and = 3 tender joints (68 joints) at both screening and baseline.

4. Active plague psoriatic skin lesion or documented history of plague psoriatic at screening.

5. hs-CRP = 3mg/L at screening.

6. Subjects either (i) do not have prior exposure to biologics (biologic-naïve) or (ii) have failed or been intolerant to 1 TNF-inhibitor (TNFi-experienced).

Exclusion Criteria:

1. Non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced psoriasis), with the exception of nail psoriasis, which is allowed.

2. Other autoimmune or autoinflammatory condition ( ie, rheumatoid arthritis, systemic lupus erythematous, gout), with the exception of inflammatory bowel disease and/or autoimmune uveitis being inactive at least 12 months before the screening, as assessed by the investigator.

3. Active fibromyalgia syndrome

4. Recent history of active infection, chronic infection history or risk of serious infection.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• HS-10374
Administered orally QD for 16 weeks
• HS-10374-matched placebo tablets
Administered orally QD for 16 weeks
• Tofacitinib 5Mg Tab,Oral
Administered orally BID for 16 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hansoh BioMedical R&D Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) response at Week 16	The ACR 20, ACR 50 or ACR 70 definition of improvement is a 20%, 50% or 70% improvement, respectively, over baseline in tender and swollen joint counts and a 20%, 50% or 70% improvement, respectively, in 3 of the 5 remaining core data set measures (Subject Global Assessment of disease activity, Physician Global Assessment of psoriatic arthritis, Subject global assessment of pain, HAQ-DI, hs-CRP).	At week 16
Secondary	Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) response at Week 12	The ACR 20, ACR 50 or ACR 70 definition of improvement is a 20%, 50% or 70% improvement, respectively, over baseline in tender and swollen joint counts and a 20%, 50% or 70% improvement, respectively, in 3 of the 5 remaining core data set measures (Subject Global Assessment of disease activity, Physician Global Assessment of psoriatic arthritis, Subject global assessment of pain, HAQ-DI, hs-CRP).	At week 12
Secondary	Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR50) response at Week 16	The ACR 20, ACR 50 or ACR 70 definition of improvement is a 20%, 50% or 70% improvement, respectively, over baseline in tender and swollen joint counts and a 20%, 50% or 70% improvement, respectively, in 3 of the 5 remaining core data set measures (Subject Global Assessment of disease activity, Physician Global Assessment of psoriatic arthritis, Subject global assessment of pain, HAQ-DI, hs-CRP).	At week 16
Secondary	Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR70) response at Week 16	The ACR 20, ACR 50 or ACR 70 definition of improvement is a 20%, 50% or 70% improvement, respectively, over baseline in tender and swollen joint counts and a 20%, 50% or 70% improvement, respectively, in 3 of the 5 remaining core data set measures (Subject Global Assessment of disease activity, Physician Global Assessment of psoriatic arthritis, Subject global assessment of pain, HAQ-DI, hs-CRP).	At week 16
Secondary	Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score at week 16	The HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a subject has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For reach item in the questionnaire the level of activity is cored from 0 to 3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as much "difficulty", and 3 has "unable to do". Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a score of 2 or more.	At week 16
Secondary	Proportion of participants meeting Psoriasis Area and Severity Index (PASI) 75/90 responses at week 16	Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75, PASI 90 responses are defined as 75% or 90% improvement in PASI score from baseline.	At week 16
Secondary	Proportion of participants meeting Static physician's global assessment (sPGA) 0/1 score at week 16	Static physician's global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "clear" or "almost clear" respectively.	At week 16
Secondary	Change from baseline in Psoriasis body surface area (BSA) at week 16	Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved.	At week 16
Secondary	Change from baseline in the dermatology life quality index (DLQI) scores at week 16	The dermatology life quality index (DLQI) is a patient reported outcome measurement. It's a questionnaire consisting of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. Each question is scored on a scale of 0 to 3, and the sum of each scores range from 0 (no impairment of life quality) to 30 (maximum impairment).	At week 16
Secondary	Change from baseline in Disease Activity Score 28 with C-reactive protein (DAS28-CRP) score at week 16	DAS28-CRP is a composite outcome measure that assesses: Numbers of joints in the hands (including metacarpophalangeal and proximal interphalangeal joints, except for distal interphalangeal joints), wrists, elbows, shoulders, and knees are swollen and/or tender over a total of 28; Hypersensitive-CRP in the blood to measure the degree of inflammation; Subject Global Assessment of disease activity.; The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: =2.6: Disease remission; 2.6 - 3.2: Low disease activity; 3.2 - 5.1: Moderate disease activity; >5.1: High disease activity.	At week 16
Secondary	Change from baseline in the Disease Activity Index for Psoriatic Arthritis Score (DAPSA) at week 16	The Disease Activity Index for Psoriatic Arthritis Score (DAPSA) is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender/painful joint count, swollen joint count, Subject Global Assessment of disease activity, Subject Global Assessment of pain, and hs-CRP.	At week 16
Secondary	Proportion of participants meeting Minimal Disease Activity (MDA) response at week 16	Minimal Disease Activity (MDA) response is defined as a subject fulfilling 5 of 7 of the following outcomes: tender joint count = 1; swollen joint count = 1; PASI = 1 or body surface area (BSA) = 3%; Subject Global Assessment of pain = 15; Subject Global Assessment of disease activity = 20; HAQ-DI = 0.5; Tender entheseal points = 1	At week 16
Secondary	Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at week 16	A composite measure calculated from the Physician Global Assessment of psoriatic arthritis, the Subject Global Assessment of disease activity, the Short Form Health Survey-36 Item (SF-36) Physical Component Summary (PCS), the swollen joint count, the tender joint count, the LEI, the tendor dactylitis count and the hs-CRP.	At week 16
Secondary	Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC) at week 16	The Psoriatic Arthritis Response Criteria (PsARC) consists of 4 measurements: tender/painful joint count, swollen joint count, Physician Global Assessment of psoriatic arthritis, and Subject Global Assessment of psoriatic arthritis. In order to be classified as a PsARC responder, subjects must achieve improvement in 2 of 4 measures, one of which must be joint pain or swelling, without worsening in any measure.	At week 16
Secondary	Change from baseline in the Short Form-36 Survey (SF-36) score at week 16	The SF-36 is a patient-reported outcome measure in clinical practice and research. The instrument includes 36 items to measure the following 8 health dimensions over the past 4 week: 1) limitations in physical activities, such as bathing or dressing; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality; and 8) general health perceptions.	At week 16
Secondary	Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score among participants with spondylitis as one of their presentations of PsA at week 16	Symptoms of spondylitis over the past week will be evaluated using the BASDAI, which consists of a 0 to 100 scale measuring discomfort, pain, and fatigue in response to 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: Fatigue; Spinal pain; Joint pain and swelling; Areas of localized tenderness; Morning stiffness duration; Morning stiffness severity A higher count indicates worse disease.	At week 16
Secondary	Change from baseline in dactylitis by Leed's dactylitis index (LDI) at week 16	Leed's Dactylitis Index (LDI) is a quantitative measurement of dactylitis in the 20 digits using a dactylometer. The circumference of the affected and contralateral digits, and tenderness of the affected digits are measured to generate a total score. A higher score indicates worse dactylitis and is based on the current evaluation.	At week 16
Secondary	Change from baseline in enthesitis by Leed's enthesitis index (LEI) at week 16	The Leed's enthesitis index (LEI) was developed specifically for PsA. An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 entheseal sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden.	At week 16
Secondary	Incidence of adverse events (AEs), serious adverse events (SAEs)		Baseline to Week 20
Secondary	Ctrough of HS-10374	Trough observed plasma concentration of HS-10374	Baseline to Week 16