Health TrialsbyHealthPanel

A Phase II Study of TollB-001 Tablets in Systemic Sclerosis

ConditionSystemic Sclerosis (SSc)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorToll Biotech Co. Ltd. (Beijing)

About this trial

The goal of this Phase II study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of TollB-001 Tablets in adults aged 18 to 70 years (male or female) with systemic sclerosis (SSc).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 70 years (inclusive), male or female.

Diagnosis of systemic sclerosis (SSc) according to the 2013 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria.

Meeting the classification criteria for diffuse cutaneous systemic sclerosis (dcSSc) as defined in the 2022 Chinese Guideline for the Diagnosis and Treatment of Systemic Sclerosis.

Evidence of active disease at screenin.

Disqualifiers

Known hypersensitivity to any active ingredient or excipient of the study drug, or to drugs of the same class.

History of scleroderma renal crisis within 6 months prior to randomization.

Clinically significant chronic intermittent bleeding within 4 weeks prior to screening (e.g., active gastric antral vascular ectasia, active peptic ulcer, or duodenal ulcer), or participants at risk of bleeding.

Any active malignancy or history of malignancy.

Trial design

Design model

Sequential

Treatments tested in this trial

  • TollB-001 Tablet

    Drug

    TollB-001 Tablets

  • Placebo

    Drug

    Placebo Tablets

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: TollB-001 Tablet Low DoseExperimental treatment 1 intervention
Group B: TollB-001 Tablet High DoseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rodnan Skin Score (mRSS)

Time frame
up to 12 weeks

Secondary outcomes

1

Composite Response Index in Systemic Sclerosis (CRISS)

Time frame
up to 12 weeks
2

Forced Vital Capacity (FVC)

Time frame
up to 12 weeks
3

Health Assessment Questionnaire- Disability Index (HAQ-DI)

Time frame
up to 12 weeks
4

Patient Global Assessment (PtGA)

Time frame
up to 12 weeks

Other outcomes

Sponsors and contacts

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

Toll Biotech Co. Ltd. (Beijing)

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: