Efficacy and Safety of SCT650C in Participants With Axial Spondyloarthritis

NCT06197009 | Not Yet Recruiting Phase 2

• 1 other identifier: SCT650C-MRCT-2-02
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SCT650C in patients with Axial Spondyloarthritis

Conditions

Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Axial Spondyloarthritis Reporting Adverse Events (AEs), Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs)

  An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalisation or prolongation of existing hospitalisation Is a congenital anomaly or birth defect Is an infection that requires treatment parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above.

  48 Weeks

• Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response

  The ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS score), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.

  week 16

Secondary Outcomes (6)

• Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 16

  week 16

• Change From Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 16

  week 16

• Change From Baseline to Week 16 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  week 16

• Change From Baseline to Week 16 in the Bath Ankylosing Spondylitis Functional Index (BASFI)

  week 16

• Percentage of Participants With Anti-SCT650C Antibodies

  week 52

Study Arms (4)

Placebo Group /Group1

PLACEBO COMPARATOR

Induction: Placebo s.c. every 2 weeks. Maintenance: 160mg SCT650C s.c. every 4 weeks

Drug: SCT650C

SCT650C low dose Group /Group 2

ACTIVE COMPARATOR

Induction: 160mg SCT650C s.c. every 2 weeks. Maintenance: 160mg SCT650C s.c. every 4 weeks

Drug: SCT650C

SCT650C medium dose Group /Group3

ACTIVE COMPARATOR

Induction: 320mg SCT650C s.c. every 2 weeks. Maintenance: 320mg SCT650C s.c. every 4 weeks

Drug: SCT650C

SCT650C high dose Group /Group 4

ACTIVE COMPARATOR

Induction: 320mg SCT650C s.c. every 2 weeks. Maintenance: 160mg SCT650C s.c. every 4 weeks

Drug: SCT650C

Interventions

SCT650C DRUG

Administered SC

Also known as: Recombinant anti-IL-17A antibody

Placebo Group /Group1; SCT650C high dose Group /Group 4; SCT650C low dose Group /Group 2; SCT650C medium dose Group /Group3

Eligibility Criteria

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

You may qualify if:

• An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the participant.
• Participant is considered reliable and capable of adhering to the protocol (e.g., able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator.
• Participant is male or female and at least 18 years of age.
• Participant has a documented diagnosis of adult-onset AS as defined by documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984) of at least 3 months' symptom duration and age of onset \<45 years.
• Participant has moderate to severe active disease at the Screening Visit as defined by each of the following:
• BASDAI score ≥4
• Spinal pain score ≥4 on a 0 to 10 numeric rating scale (NRS) (from BASDAI Item 2)
• Participants must have at least 1 of the following:
• inadequate response to NSAID therapy
• intolerance to administration of at least 1 NSAID
• contraindication(s) to NSAID therapy An inadequate response to NSAID is defined as not improving after 4 weeks of using NSAID therapy at the recommended dose or failing to respond to at least 2 NSAIDs at the recommended dose for 2 weeks each.
• Participants who are regularly taking NSAIDs/COX-2 inhibitors as part of their SPA therapy are required to be on a stable dose for at least 14 days before Baseline and should remain on a stable dose up to week 16.
• Participants taking corticosteroids must be on an average daily dose of ≤10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose up to week 16.
• Participants taking Methotrexate (MTX, ≤25mg/week), sulfasalazine (up to 3g/day) or hydroxychloroquine (up to 400mg per day total) are allowed to continue their medication if the dose has been stable dose for at least 4 weeks before randomization. Dose, dosing schedule, and route of administration (oral or subcutaneous) should remain stable up to week 16.
• Subject may have prior treatment TNF inhibitor (TNFi), which must have used no more than 2 TNFi and must have been discontinued.

You may not qualify if:

• Female participant who is breastfeeding, pregnant, or planning to become pregnant during the study or within 40 weeks following the final dose of IMP. Male participant planning a partner pregnancy during the study or within 40 weeks following the final dose.
• Participant has participated in another study of a medication under investigation within the last 3 months or at least 5 half-lives of the IMP, whichever is greater, or is currently participating in another study of a medication under investigation. Participants who participated in any clinical trial but were enrolled in placebo group and did not receive any IMP in the prior study are eligible for this study.
• Participant has received any IL-17 response modifier.
• Participant has received more than 3 bDMARDs to treat axSpA.
• Participant has a known hypersensitivity to any excipients of SCT650C.
• Participant has total ankylosis of the spine or a diagnosis of any other inflammatory arthritis e.g., RA, systemic lupus erythematosus, sarcoidosis, psoriatic arthritis, or reactive arthritis. Participants with a diagnosis of Crohn's disease or ulcerative colitis are allowed if they have no active symptomatic disease at Screening or Baseline.
• Participant has a secondary noninflammatory condition (e.g., osteoarthritis, fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with the evaluation of the effect of study drug on the participant's primary diagnosis of active SpA.
• Participant has:
• A history of chronic or recurrent infections (e.g., more than 3 episodes requiring systemic antibiotics or antivirals during the preceding year). Minor illnesses like common cold or transient, localized infections that may have been treated with a short course of antibiotic therapy (up to 7 days) need not be counted in this assessment.
• A serious or life-threatening infection within the 6 months prior to the Baseline Visit (including herpes zoster) or hospitalization for any infection in the last 6 months.
• Any current sign or symptom that may indicate an active infection (except for common cold) or has had an infection requiring systemic antibiotics within 2 weeks prior to Baseline.
• A high risk of infection in the Investigator's opinion (e.g., participants with leg ulcers, indwelling urinary catheter, prior prosthetic joint infection at any time, participants who are permanently bedridden or wheelchair assisted).
• Participant has a history of or current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, nontuberculous mycobacteria (NTMB), Blastomyces, or Aspergillus or current active Candidiasis (local or systemic)
• Participant has acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection. Participants who have evidence of, or test positive for, hepatitis B or hepatitis C are excluded as follows:
• A positive test for the hepatitis B virus (HBV) is defined as: 1) positive for hepatitis B surface antigen (HBsAg+), or 2) HBsAg is negative, HBcAb is positive and HBV-DNA test results ≥ the upper limit of the reference value of each center or need antiviral treatment.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Hacettepe University Faculty of Medicine

Ankara, Hacettepe Mh., 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Umut Kalyoncu

  Hacettepe University Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomei Yang, PhD

CONTACT

13681198652; xiaomei_yang@sinocelltech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 9, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 9, 2024

Record last verified: 2023-12

Locations

TU (1)