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

NCT07745725 | Not Yet Recruiting Phase 2

• 2 other identifiers: TLBT-TollB-001-SSC-IICTR20261937
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Systemic Sclerosis (SSc)

Outcome Measures

Primary Outcomes (1)

• Rodnan Skin Score (mRSS)

  up to 12 weeks

Secondary Outcomes (13)

• Composite Response Index in Systemic Sclerosis (CRISS)

  up to 12 weeks

• Forced Vital Capacity (FVC)

  up to 12 weeks

• Health Assessment Questionnaire- Disability Index (HAQ-DI)

  up to 12 weeks

• Patient Global Assessment (PtGA)

  up to 12 weeks

• Incidence and Severity of Adverse Events

  up to 12 weeks

Study Arms (3)

TollB-001 Tablet Low Dose

EXPERIMENTAL

Eligible participants will be randomized to receive TollB-001 tablet low dose, administered once daily for 12 consecutive weeks.

Drug: TollB-001 Tablet

TollB-001 Tablet High Dose

EXPERIMENTAL

Eligible participants will be randomized to receive TollB-001 tablet high dose, administered once daily for 12 consecutive weeks.

Drug: TollB-001 Tablet

Placebo

PLACEBO COMPARATOR

Eligible participants will be randomized to receive matching placebo, administered once daily for 12 consecutive weeks.

Drug: Placebo

Interventions

TollB-001 Tablet DRUG

TollB-001 Tablets

TollB-001 Tablet High Dose; TollB-001 Tablet Low Dose

Placebo DRUG

Placebo Tablets

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• Female participants of childbearing potential and male participants must use effective contraception during the study and for 3 months after the last dose of study drug. Male participants whose partners are females of reproductive potential must agree to use effective contraception and refrain from donating sperm during the study and for 3 months after the last dose. Female participants of childbearing potential must have a negative pregnancy test.
• Able to swallow all study medications.
• Willing and able to comply with the study protocol (e.g., able to understand and complete questionnaires, adhere to visit schedules, and take study medication) and provide signed informed consent.

You may not qualify if:

• 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.
• Presence of severe, uncontrolled diseases.
• Major surgery within 8 weeks prior to randomization, or expected to undergo major surgery after enrollment.
• Drug or alcohol abuse or dependence at screening, or a history of drug or alcohol abuse or dependence within 6 months prior to randomization.
• Participation in another clinical trial within 3 months prior to the date of informed consent, or planning to participate in another clinical trial during the study period.
• Participants who, in the investigator's judgment, are unsuitable for participation in this clinical trial.

Sponsors & Collaborators

• Toll Biotech Co. Ltd. (Beijing): lead

Study Sites (2)

Toll Biotech, 2108-B007, No. 9 West Beisihuan Road, Haidian District, Beijing, People's Republic of China

Beijing, Beijing Municipality, 100083, China

Location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 102206, China

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Wang weili

CONTACT

010-80710966; wangweili@toll-biotech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 4, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)