Telitacicept for PGNMID: A Single-Arm Study

NCT07111338 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: 2025R-00142025SF047
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, prospective, single-arm study will evaluate the efficacy and safety of telitacicept in 10 adults with biopsy-proven proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID). Eligible participants (≥18 y, ≥1 g/day proteinuria, eGFR ≥20 mL/min/1.73 m²) will receive 160 mg telitacicept subcutaneously once weekly for 24 weeks after a 12-week run-in on maximally tolerated ACEi/ARB. The primary endpoint is change in 24-hour urine protein from baseline to Week 24. Secondary endpoints include changes in eGFR, urine red-blood-cell count, and serum immunoglobulin/complement levels. Safety will be monitored throughout. Recruitment is planned from May 2025 to May 2027 at Peking University First Hospital.

Conditions

Proliferative Glomerulonephritis With Monoclonal Immunoglobulin Deposits

Keywords

Telitacicept; PGNMID; proliferative glomerulonephritis; MGRS; BLyS/APRIL inhibitor

Outcome Measures

Primary Outcomes (1)

• Change in 24-hour urine protein excretion from baseline to Week 24

  Absolute change (g/24 h) in quantitative proteinuria from baseline (Week 0) to Week 24 after the first telitacicept dose, measured by 24-hour urine collection and averaged from two consecutive collections obtained within 7 days of the target visit.

  Baseline (Week 0) to Week 24

Secondary Outcomes (2)

• Change in estimated glomerular filtration rate (eGFR) from baseline to Week 24

  Baseline (Week 0) to Week 24

• Urinary Red-Blood-Cell Count

  Time Frame: Baseline (Week 0) to Week 24

Other Outcomes (3)

• Serum Immunoglobulin Levels

  Time Frame: Baseline (Week 0) to Week 24

• Serum Complement Levels

  Time Frame: Baseline (Week 0) to Week 24

• Safety & Tolerability

  Time Frame: Week 0 through Week 28

Study Arms (1)

Telitacicept 160 mg Subcutaneous Once Weekly

EXPERIMENTAL

Participants receive telitacicept 160 mg by subcutaneous injection once weekly for 24 consecutive weeks. No placebo or active comparator is provided.

Drug: Telitacicept 160mg

Interventions

Telitacicept 160mg DRUG

Telitacicept (RC18) is a recombinant TACI-Fc fusion protein that simultaneously neutralizes B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), thereby inhibiting B-cell differentiation and plasma-cell survival. In this study, it is supplied as a sterile, preservative-free, lyophilized powder (160 mg/vial) that is reconstituted with 1 mL water for injection and administered subcutaneously into the abdomen or thigh at a fixed dose of 160 mg once weekly for 24 weeks. Each injection is performed by trained study personnel, and pre-filled backup syringes are available to ensure exact dosing. No dose escalation or tapering is planned; dose reductions or temporary discontinuation are allowed only for predefined safety criteria.

Telitacicept 160 mg Subcutaneous Once Weekly

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Renal biopsy consistent with proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID) confirmed by central pathologic review
• hour urine protein ≥ 1 g on two occasions ≥ 4 weeks apart while receiving optimal renin-angiotensin system blockade (ACEi or ARB at maximal tolerated dose)
• Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m² calculated by CKD-EPI equation
• Willing and able to provide written informed consent and comply with all study procedures

You may not qualify if:

• Rapidly progressive glomerulonephritis or crescentic disease (\>50 % crescents)
• Known malignant hematologic disorders (e.g., multiple myeloma, lymphoma)
• Active malignancy (except adequately treated basal-cell carcinoma) within 5 years
• Neutrophil count \< 1.0 × 10⁹/L, hemoglobin \< 80 g/L, or platelet count \< 50 × 10⁹/L
• ALT or AST \> 2.5 × upper limit of normal (ULN) or total bilirubin \> 1.5 × ULN
• Chronic obstructive pulmonary disease (COPD) requiring systemic steroids or Stage III/IV heart failure (NYHA)
• Systemic immunosuppressive or biologic therapy (e.g., cyclophosphamide, rituximab, bortezomib, lenalidomide, tacrolimus, mycophenolate, etc.) within 3 months prior to screening
• Chronic or latent infection: active tuberculosis, HBV (HBsAg-positive or HBV-DNA-positive), HCV antibody-positive, or HIV-positive
• Live vaccine within 4 weeks of screening
• Known hypersensitivity to telitacicept or any excipients
• Pregnancy, breastfeeding, or inadequate contraception (women of child-bearing potential and men not using highly effective contraception)
• Any condition that, in the investigator's opinion, would compromise participant safety or interfere with study conduct

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital, Renal Division

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Interventions

telitacicept

Study Officials

• Fude Zhou, MD

  Peking University First Hospital

  STUDY DIRECTOR

Study Design

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

Model Details: Single-group assignment: all eligible participants receive telitacicept 160 mg subcutaneously once weekly for 24 weeks without concurrent control or randomization.

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: July 12, 2025
• Primary Completion (Estimated): May 29, 2027
• Study Completion (Estimated): May 29, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-02

Locations

CN (1)