Health TrialsbyHealthPanel

A Study of SCTB35 in Patients with Systemic Lupus Erythematosus

ConditionSystem Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSinocelltech Ltd.

About this trial

This study is a multicenter Phase Ib/II clinical trial aimed at evaluating the safety, tolerability and efficacy of SCTB35 in patients with systemic lupus erythematosus (SLE).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years；

Diagnosed with SLE for ≥12 weeks prior to screening (2019-ACR/EULAR criteria);

SLEDAI-2K ≥ 8 at screening, or ≥6 if there is hypocomplementemia or elevated anti-dsDNA antibody levels;

Positive for ANA (1:80) or positive for anti-dsDNA and/or anti-Sm antibodies within the last 12 months or at screening;

Disqualifiers

Severe active or unstable lupus-related neuropsychiatric disorders;

Other autoimmune diseases that may interfere with efficacy evaluation;

Catastrophic antiphospholipid syndrome;

Received live vaccines or attenuated vaccines within 28 days prior to baseline or screening;

Trial design

Design model

Single group

Treatments tested in this trial

  • SCTB35 injection

    Biological/Vaccine

    SCTB35 will be subcutaneously administered at a dose as specified in the respective dose-escalation cohorts. Then, the RP2D and other appropriate doses of SCTB35 will be applied for the dose-expansion cohorts.

Treatment groups

168 Participants
are divided into 1 treatment group
Group A: Experimental: SCTB35Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-escalation part： Incidence rate of adverse event (AE)

To evaluate the incidence rates of treatment emergent adverse event (TEAE), treatment-related TEAE (TRAE), serious adverse event (SAE), adverse event with special interest (AESI)

Time frame
From first dose to the 24 weeks
2

Dose-expansion part：SRI-4

Percentage of subjects who achieved an SRI-4 response at 24 weeks；

Time frame
Up to Week 24

Secondary outcomes

1

Dose-escalation part： SLEDAI-2K

Percentage of subjects with a reduction of ≥4 points in SLEDAI-2K at 12 and 24 weeks.

Time frame
Up to week 12, 24
2

Dose-escalation part： physician global assessment (PGA)

Percentage of subjects with no worsening in PGA, where worsening is defined as a ≥0.3 point increase in PGA at 12 and 24 weeks.

Time frame
Up to week 12, 24
3

Dose-escalation part：Immunogenicity；

Serum anti-SCTB35 antibody and anti-SCTB35 antibody levels before and after administration

Time frame
From baseline to Week 24
4

Dose-expansion part：SLEDAI-2K

Percentage of subjects with a reduction of ≥4 points in SLEDAI-2K at 12 and 24 weeks.

Time frame
Up to week 12, 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sinocelltech Ltd.

Lead sponsor

Source ClinicalTrials.gov
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