Systemic Sclerosis (SSc)Phase 2NCT07745725
A Phase II Study of TollB-001 Tablets in Systemic Sclerosis
A Phase 2 study testing TollB-001 Tablet in people with Systemic Sclerosis (SSc), run by Toll Biotech Co. Ltd. (Beijing) at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Sclerosis (SSc)
- What is being tested?
- TollB-001 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2026to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Toll Biotech, 2108-B007, No. 9 West Beisihuan Road, Haidian District, Beijing, People's Republic of China
Beijing, Beijing Municipality, 100083
Weili Wang, 86+010-80710966, wangweili@toll-biotech.com
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 102206
Mengtao Li, 010-69151188, mengtao.li@cstar.org.cn
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of TollB-001 Tablets in Patients With Systemic Sclerosis
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).
Read the detailed description
Study Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of TollB-001 in Adult Patients with Systemic Sclerosis (SSc) Study Design: This is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of TollB-001 in adult patients with systemic sclerosis (SSc).
Sample Size and Target Population: A total of 36 patients with SSc are planned for enrollment. Eligible patients must have a disease duration of ≤ 60 months from the first onset of non-Raynaud's phenomenon and a modified Rodnan Skin Score (mRSS) between 10 and 40 (inclusive) at the screening visit.
Study Phases: The study consists of three sequential phases:
Screening Period: Up to 28 days
Treatment Period: 90 days, comprising:
Single-Dose Phase: 3 days (dosing on Day 1 only) Multiple-Dose Phase: 87 days (consecutive daily dosing from Day 4 through Day 87, for a total of 84 days of dosing) Follow-up Period: 28 days following the last dose
- Conditions
- Systemic Sclerosis (SSc)
- Being tested
- TollB-001 Tablet, Placebo
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TollB-001 TabletDrug
TollB-001 Tablets
PlaceboDrug
Placebo Tablets
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: TollB-001 Tablet |
| Placebo | Placebo comparator | Eligible participants will be randomized to receive matching placebo, administered once daily for 12 consecutive weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rodnan Skin Score (mRSS)
Measured: up to 12 weeks
Secondary outcomes (13)
Composite Response Index in Systemic Sclerosis (CRISS)
Measured: up to 12 weeks
Forced Vital Capacity (FVC)
Measured: up to 12 weeks
Health Assessment Questionnaire- Disability Index (HAQ-DI)
Measured: up to 12 weeks
Patient Global Assessment (PtGA)
Measured: up to 12 weeks
Incidence and Severity of Adverse Events
Measured: up to 12 weeks
Incidence and Severity of Adverse Reactions
Measured: up to 12 weeks
Incidence of Serious Adverse Events
Measured: up to 12 weeks
Incidence of Serious Adverse Reactions
Measured: up to 12 weeks
The four major vital signs, including body temperature, pulse (heart rate), respiration, and blood pressure.
Measured: up to 12 weeks
The 12-lead electrocardiogram (ECG) includes parameters such as heart rate, RR interval, PR interval, QT interval, QRS interval, and the corrected QT interval (QTcf, where QTcf = QT / RR^0.33).
Measured: up to 12 weeks
Routine blood test includes parameter such as white blood cell, lymphocyte count and percentage, neutrophil count and percentage, monocyte count and percentage, eosinophil count, basophil count, , red blood cell, hemoglobin, hematocrit, platelet count.
Measured: up to 12 weeks
Blood biochemical parameters such as: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, indirect bilirubin, total protein, albumin, alkaline phosphatase, gamma-glutamyl transferase (GGT) and urea, etc.
Measured: up to 12 weeks
Coagulation function parameters suc as the International Normalized Ratio (INR), activated partial thromboplastin time (APTT), prothrombin time (PT), and fibrinogen.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toll Biotech Co. Ltd. (Beijing)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745725
- Sponsor's protocol ID
- TLBT-TollB-001-SSC-II
- Other IDs
- CTR20261937
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of TollB-001 Tablets in Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT07745725
- Acronym / sponsor ID
- TLBT-TollB-001-SSC-II
- Conditions
- Systemic Sclerosis (SSc)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Toll Biotech Co. Ltd. (Beijing)Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Study Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of TollB-001 in Adult Patients with Systemic Sclerosis (SSc) Study Design: This is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of TollB-001 in adult patients with systemic sclerosis (SSc).
Sample Size and Target Population: A total of 36 patients with SSc are planned for enrollment. Eligible patients must have a disease duration of ≤ 60 months from the first onset of non-Raynaud's phenomenon and a modified Rodnan Skin Score (mRSS) between 10 and 40 (inclusive) at the screening visit.
Study Phases: The study consists of three sequential phases:
Screening Period: Up to 28 days
Treatment Period: 90 days, comprising:
Single-Dose Phase: 3 days (dosing on Day 1 only) Multiple-Dose Phase: 87 days (consecutive daily dosing from Day 4 through Day 87, for a total of 84 days of dosing) Follow-up Period: 28 days following the last dose
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TollB-001 Tablet Low Dose | Experimental | Drug: TollB-001 TabletEligible participants will be randomized to receive TollB-001 tablet low dose, administered once daily for 12 consecutive weeks. |
| TollB-001 Tablet High Dose | Experimental | Drug: TollB-001 TabletEligible participants will be randomized to receive TollB-001 tablet high dose, administered once daily for 12 consecutive weeks. |
| Placebo | Placebo comparator | Drug: PlaceboEligible participants will be randomized to receive matching placebo, administered once daily for 12 consecutive weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TollB-001 TabletTollB-001 Tablets | Drug | TollB-001 Tablet High Dose, TollB-001 Tablet Low Dose |
| PlaceboPlacebo Tablets | Drug | Placebo |
Primary outcome
Rodnan Skin Score (mRSS)
Time frame: up to 12 weeks
13 secondary outcomes
Composite Response Index in Systemic Sclerosis (CRISS)
Time frame: up to 12 weeks
Forced Vital Capacity (FVC)
Time frame: up to 12 weeks
Health Assessment Questionnaire- Disability Index (HAQ-DI)
Time frame: up to 12 weeks
Patient Global Assessment (PtGA)
Time frame: up to 12 weeks
Incidence and Severity of Adverse Events
Time frame: up to 12 weeks
Incidence and Severity of Adverse Reactions
Time frame: up to 12 weeks
Incidence of Serious Adverse Events
Time frame: up to 12 weeks
Incidence of Serious Adverse Reactions
Time frame: up to 12 weeks
The four major vital signs, including body temperature, pulse (heart rate), respiration, and blood pressure.
Time frame: up to 12 weeks
The 12-lead electrocardiogram (ECG) includes parameters such as heart rate, RR interval, PR interval, QT interval, QRS interval, and the corrected QT interval (QTcf, where QTcf = QT / RR^0.33).
Time frame: up to 12 weeks
Routine blood test includes parameter such as white blood cell, lymphocyte count and percentage, neutrophil count and percentage, monocyte count and percentage, eosinophil count, basophil count, , red blood cell, hemoglobin, hematocrit, platelet count.
Time frame: up to 12 weeks
Blood biochemical parameters such as: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, indirect bilirubin, total protein, albumin, alkaline phosphatase, gamma-glutamyl transferase (GGT) and urea, etc.
Time frame: up to 12 weeks
Coagulation function parameters suc as the International Normalized Ratio (INR), activated partial thromboplastin time (APTT), prothrombin time (PT), and fibrinogen.
Time frame: up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Systemic Sclerosis (SSc)
RecruitingObservational study
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
Systemic Sclerosis (SSc), Calcinosis Cutis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
RecruitingPhase 1
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Recruiting
Tissue Modeling in Systemic Sclerosis Using Induced Pluripotent Stem Cells (iPSCs)
Systemic Sclerosis (SSc)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TollB-001 Tablet in people with Systemic Sclerosis (SSc), run by Toll Biotech Co. Ltd. (Beijing) at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang weili (010-80710966, wangweili@toll-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rodnan Skin Score (mRSS) (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.