Systemic Sclerosis (SSc)Early Phase 1NCT07159009
A Study of GB261 in Systemic Sclerosis
A Early Phase 1 study testing Biological: GB261 in people with Systemic Sclerosis (SSc), run by Ruijin Hospital.
Trial summary
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of GB261 in patients with SSc. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Sclerosis (SSc)
- What is being tested?
- Biological: GB261
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 4 Sep 2025to 31 Jul 2027
- Phase
- Early Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years old at the time of signing the informed consent form (ICF)
- Diagnosis of SSc according to the 2013 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) classification criteria
- Diffuse cutaneous SSc according to the LeRoy criteria
- Positive for at least 1 SSc-specific parameter as specified in the protocol;
- Disease duration of ≤ 7 years
- mRSS ≥ 15
- Inadequate response to therapies defined in the protocol
Who cannot join
- Inadequate clinical laboratory parameters at Screening:
- Receipt of or inability to discontinue any excluded as specified in the protocol:
- Receipt of live vaccine within 4 weeks prior to Screening
- Presence of any concomitant autoimmune disease other than the disease being studied
- Receiving or anticipated to require total parenteral nutrition during the study
- Active or history of intestinal pseudo-obstruction OR small intestinal bacteria overgrowth
Show all 15Show fewer
- Active or history of gastric antral vascular ectasia
- Active digital ischemia with gangrene OR requiring antibiotics or amputation at Screening or during the study
- Active or history of scleroderma renal crisis
- History of progressive multifocal leukoencephalopathy
- History of primary immunodeficiency or a hereditary deficiency of the complement system
- Central nervous system (CNS) disease
- Have presence of 1 or more significant concurrent medical conditions per investigator judgment
- Have a diagnosis or history of malignant disease within 5 years prior to Screening
- Inability to comply with contraception requirements as specified in the protocol
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of GB261 in Systemic Sclerosis
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of GB261 in patients with SSc.
Read the detailed description
An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of GB261 in Systemic Sclerosis
- Conditions
- Systemic Sclerosis (SSc)
- Being tested
- Biological: GB261
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: GB261Drug
GB261 will be dosed according to the protocol
| Study group | Role | What they receive |
|---|---|---|
| A study of GB261 in patients with Systemic Sclerosis (SSc) | Experimental | Not described Receives: Drug: Biological: GB261 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs) through end of study
Measured: 52weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start4 Sep 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Jul 2027 (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.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159009
- Sponsor's protocol ID
- CND261-RUJN -1
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- 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 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of GB261 in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT07159009
- Acronym / sponsor ID
- CND261-RUJN -1
- Conditions
- Systemic Sclerosis (SSc)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 4 Sep 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 8 Sep 2025 (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 purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of GB261 in patients with SSc.
Detailed description
An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of GB261 in Systemic Sclerosis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A study of GB261 in patients with Systemic Sclerosis (SSc) | Experimental | Drug: Biological: GB261 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 to 75 years old at the time of signing the informed consent form (ICF)
- Diagnosis of SSc according to the 2013 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) classification criteria
- Diffuse cutaneous SSc according to the LeRoy criteria
- Positive for at least 1 SSc-specific parameter as specified in the protocol;
- Disease duration of ≤ 7 years
Key exclusion criteria (15 listed)
- Inadequate clinical laboratory parameters at Screening:
- Receipt of or inability to discontinue any excluded as specified in the protocol:
- Receipt of live vaccine within 4 weeks prior to Screening
- Presence of any concomitant autoimmune disease other than the disease being studied
- Receiving or anticipated to require total parenteral nutrition during the study
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 |
|---|---|---|
| Biological: GB261GB261 will be dosed according to the protocol | Drug | A study of GB261 in patients with Systemic Sclerosis (SSc) |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs) through end of study
Time frame: 52weeks
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 8 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Biological: GB261 in people with Systemic Sclerosis (SSc), run by Ruijin Hospital.
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 15 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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Chengde Yang (13501717833, yangchengde@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs) through end of study (time frame: 52weeks). 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 8 Sep 2025.