Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis

NCT06375005 | Recruiting Phase 2

• 1 other identifier: 2024-0381
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 9

Brief Summary

This study is a prospective, open-label, randomized, controlled, multi-center clinical trial. The aim of this study is to investigate the efficacy and safety of Telitacicept in adults with early diffuse cutaneous systemic sclerosis (dcSSc), with Mycophenolate Mofetil (MMF) administered as a background treatment.

Conditions

Diffuse Cutaneous Systemic Sclerosis

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 48

  Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.

  Baseline, Week 48

• Percentage of Participants With Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Week 52

Secondary Outcomes (13)

• Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24

  Baseline, Week 24

• Percentage of Participants Who Improved in Modified Rodnan Skin Score (mRSS) by ≥20%, ≥40%, ≥60% From Baseline to Week 24 and Week 48

  Baseline, Week 24 and 48

• American College of Rheumatology Composite Response Index for Systemic Sclerosis (ACR-CRISS) and Revised ACR-CRISS at Week 24 and 48

  Week 24 and 48

• Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted at Week 24 and Week 48

  Week 24 and 48

• Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percent Predicted (Corrected For Hemoglobin) at Week 24 and Week 48

  Week 24 and 48

Study Arms (2)

Mycophenolate Mofetil + Telitacicept

EXPERIMENTAL

All patients who enroll in this trial will receive mycophenolate mofetil (MMF), which is a drug commonly given to patients with systemic sclerosis in clinical practice. Participants will be treated with MMF 0.5g twice a day for 48 weeks. Telitacicept will be subcutaneously injected at a dose of 160mg per week, lasting for 48 weeks.

Drug: Telitacicept; Drug: Mycophenolate Mofetil

Mycophenolate Mofetil

ACTIVE COMPARATOR

Participants will be treated with MMF 0.5g twice a day for 48 weeks.

Drug: Mycophenolate Mofetil

Interventions

Telitacicept DRUG

Telitacicept is fusion protein comprising a recombinant transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor fused to the fragment crystallizable (Fc) domain of human immunoglobulin G (IgG). Telitacicept binds to and neutralizes the activity of two cell-signalling molecules, B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), thereby suppressing the development and survival of plasma cells and mature B cells. Telitacicept will be subcutaneously injected at a dose of 160mg per week, lasting for 48 weeks.

Also known as: Taiai for commercial name

Mycophenolate Mofetil + Telitacicept

Mycophenolate Mofetil DRUG

All patients will receive background therapy with Mycophenolate Mofetil (MMF), administered orally at a dose of 0.5g twice daily for 48 weeks.

Also known as: MMF

Mycophenolate Mofetil; Mycophenolate Mofetil + Telitacicept

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged 18-70 years old.
• Systemic sclerosis, as defined by ACR/EULAR (American College of Rheumatology/European League Against Rheumatism) 2013 criteria.
• dcSSc (diffuse cutaneous systemic sclerosis) according to the LeRoy criteria.
• Disease duration of ≤ 18 months (defined as time from the first non-Raynaud's phenomenon manifestation).
• ≥ 10 mRSS units at the screening visit.
• Negative serum pregnancy test in a woman of childbearing potential at the screening visit.
• Ability to render informed consent in accordance with institutional guidelines.

You may not qualify if:

• Limited scleroderma.
• Disease duration of greater than 3 years.
• Rheumatic autoimmune disease other than SSc.
• Systemic sclerosis-like illness associated with environmental agents such as vinyl chloride, or bleomycin.
• Any prior history of renal crisis.
• Intermediate- or high-risk pulmonary arterial hypertension.
• Pulmonary disease with FVC \< 50% of predicted or DLCO (hemoglobin-corrected) \< 40% of predicted at screening or requires oxygen therapy.
• Underwent major surgery within 8 weeks prior to randomization or planned major surgery during the trial period.
• Use of immunosuppressive therapies, including methotrexate, azathioprine, hydroxychloroquine, leflunomide, tacrolimus, sirolimus, and mycophenolate mofetil within 4 weeks prior to randomization, and cyclophosphamide within 3 months prior to randomization.
• Use of other anti-fibrotic agents, including colchicine, D-penicillamine, thalidomide, nintedanib, pirfenidone, tyrosine kinase inhibitors (imatinib, nilotinib, dasatinib) within 4 weeks prior to randomization.
• Use of corticosteroids at doses exceeding the equivalent of prednisone 10 mg daily, or intravenous and intramuscular corticosteroid injections within 4 weeks prior to randomization.
• Use of Intravenous Immunoglobulin (IVIG) within 12 weeks within 4 weeks prior to randomization.
• Prior use of belimumab, rituximab, or other B-Cell depleting therapies ever.
• Use of other biologics or small molecule targeted therapies, including anakinra within 1 week prior to randomization, ixekizumab within 2 weeks prior to randomization, and infliximab, certolizumab pegol, golimumab, adalimumab, abatacept, tocilizumab within 8 weeks prior to randomization, and janus kinase inhibitors within 2 weeks prior to randomization.
• Prior use of other cell depletion therapies.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (9)

Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, 225009, China

RECRUITING

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

RECRUITING

Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine

Hangzhou, Zhejiang, 310016, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

RECRUITING

Changxing People's Hospital

Huzhou, Zhejiang, 313100, China

RECRUITING

The First Hospital of Jiaxing

Jiaxing, Zhejiang, 314000, China

RECRUITING

Ningbo First Hospital

Ningbo, Zhejiang, 315000, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

telitacicept; Mycophenolic Acid

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• JING XUE, PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JING XUE, PhD

CONTACT

86-13858121751; jingxue@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: January 6, 2025
• Primary Completion (Estimated): January 6, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 11, 2025

Record last verified: 2024-03

Locations

CN (9)