A Phase 3 Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Remegen Co. Ltd., Remegen Co. Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

30 Nov 2022 → 1 Feb 2025

Decision date (initial)

2022-09-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

RemeGen Co., Ltd.

External identifiers

EU CT number

2022-500445-24-00

ClinicalTrials.gov

NCT05306574

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacodynamic, Dose response, Safety, Pharmacokinetic

Stage 1: To evaluate the efficacy, safety, PK and PD of telitacicept 160 mg and 240 mg administered as a subcutaneous injection via prefilled syringes (PFS) weekly for 52 weeks in adult patients with active SLE while receiving SOC treatment.

Stage 2: To evaluate the efficacy of telitacicept at Week 52 in adult subjects with moderately to severely active SLE with an inadequate response to SoC therapy.

Secondary objectives 6

1. Stage 1: To evaluate the efficacy of telitacicept (160 mg and 240 mg) compared to placebo when administered as a subcutaneous injection via prefilled syringes weekly for 24 weeks in adult patients with moderately to severely active SLE with an inadequate response to SOC SLE treatment.
2. Stage 2: To evaluate the efficacy of telitacicept at Week 24 in adult subjects with moderately to severely active SLE with an inadequate response to SoC therapy.
3. Stage 2: To evaluate the GC sparing effect of telitacicept, when added to SoC therapy.
4. Stage 2: To evaluate the efficacy of telitacicept in reducing SLE flares when added to SoC therapy.
5. Stage 2: To evaluate the GC sparing effect of telitacicept and improvement in disease activity when added to SoC therapy.
6. Stage 2: To evaluate the efficacy of telitacicep measured by at least partial improvement in all organ systems active at baseline when added to SoC therapy.

Conditions and MedDRA coding

Moderately to Severely Active Systemic Lupus Erythematosus

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

EMA paediatric investigation plan (PIP)

EMEA-002824-PIP01-20

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Has had a diagnosis of SLE for at least 6 months prior to the screening Visit.
2. Stage 2: To evaluate the efficacy of telitacicept at Week 24 in adult subjects with moderately to severely active SLE with inadequate response to SoC therapy.
3. Clinical SLEDAI score of ≥ 4 at Day 0 prior to randomization
4. At least one positive serologic parameter within the screening period
5. Currently receiving at least one of the SoC SLE therapies: oral GCs, antimalarial and/or immunosuppressive agent.
6. Other protocol defined inclusion criteria may apply.

Exclusion criteria 6

1. Active or unstable neuropsychiatric SLE or lupus nephritis
2. Autoimmune or rheumatic disease other than SLE
3. Significant, uncontrolled medical conditions not related to SLE
4. Active and/or severe viral, bacterial or fungal infection
5. History of malignancy within 5 years
6. Other protocol defined exclusion criteria may apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Stage 1: The proportion of patients achieving a response in an SLE Responder Index (SRI-4) at Week 52; Safety and tolerability of telitacicept 160 mg and 240 mg in adult patients with active SLE; PK and PD of telitacicept 160 mg and 240 mg when administered as a subcutaneous injection via prefilled syringes in adult patients with active SLE.
2. Stage 2: The proportion of subjects achieving an SLE Responder Index (SRI-4) at Week 52.

Secondary endpoints 5

1. Stage 1: The proportion of adult patients achieving a response in an SLE Responder Index (SRI-4) at Week 24.
2. Stage 2: The proportion of subjects achieving a BILAG-based Combined Lupus Assessment (BICLA) response at week 52
3. Stage 2: Among subjects who were on an average daily dose of >7.5 mg/day prednisone or equivalent at baseline, the proportion of those subjects achieving a GC dose reduction of ≥25% from baseline to ≤7.5 mg/day prednisone or equivalent by Week 40 and maintaining that dose through Week 52.
4. Stage 2: Time to flare assessed by SFI from baseline through Week 52
5. Stage 2: The proportion of subjects achieving an SRI-4 response at Week 52, while maintaining an average daily dose of ≤7.5 prednisone or equivalent between Week 40 and Week 52.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Remegen Co. Ltd.

Sponsor organisation

Remegen Co. Ltd.

Address

58 Middle Beijing Road, Pilot Free Trade Zone Pilot Free Trade Zone

City

Yantai

Postcode

264006

Country

China

Scientific contact point

Organisation

Remegen Co. Ltd.

Contact name

RemeGen clinical trial information desk

Public contact point

Organisation

Remegen Co. Ltd.

Contact name

RemeGen clinical trial information desk

Third parties 2

Remegen Co. Ltd.

Sponsor organisation

Remegen Co. Ltd.

Address

58 Middle Beijing Road, Pilot Free Trade Zone Pilot Free Trade Zone

City

Yantai

Postcode

264006

Country

China

Locations

6 EU/EEA countries · 33 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 156 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

17 submissions — initial application plus substantial / non-substantial modifications