Rheumatoid Arthritis (RA)Phase 2JAB-8263NCT07684157
A Phase IIa Study of JAB-8263 in Patients With Active Rheumatoid Arthritis
A Phase 2 study testing JAB-8263 in people with Rheumatoid Arthritis (RA), run by Jacobio Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study is an open-label, multi-center Phase IIa study. The study is divided into two phases. The first phase is a safety exploration phase. Participants with active rheumatoid arthritis were enrolled and treated with JAB-8263 alone for 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- JAB-8263
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2026to 31 Dec 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old and <75 years old at the time of signing the informed consent form, regardless of gender;
- Active rheumatoid arthritis, ESR or C-reactive protein> upper limit of normal
- Meets the 2010 American College of Rheumatology ACR/EULAR RA classification standards
- Participants have recovered from adverse reactions to previous antirheumatic treatment.
Who cannot join
- Use of topical glucocorticoids within 2 weeks before the first dose of investigational product or have received epidural, intraarticular, intramuscular, oral or intravenous glucocorticoids within 4 weeks, and do not use adrenocorticotropin;
- Use of NSAIDs within 1 week before first dose of investigational product
- Known or suspected allergies to the investigational product or any of its components;
- Current active shingles virus infection, including shingles or herpes simplex types 1 and 2 (confirmed by physical examination and medical history); participants had a history of severe herpes infection, including any disseminated disease, shingles in multiple skin areas, herpes encephalitis, ocular herpes, or recurrent shingles (2 episodes greater than or equal to 2 episodes within 2 years);
- Have evidence of active tuberculosis (TB) or have previously had evidence of active TB and have not received appropriate documented treatment;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality
Xuan Dr. Zhang, +86 010-58115094, zxlab@outlook.com
About this study
Official title: A Phase IIa Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JAB-8263 in Patients With Active Rheumatoid Arthritis
This study is an open-label, multi-center Phase IIa study. The study is divided into two phases. The first phase is a safety exploration phase. Participants with active rheumatoid arthritis were enrolled and treated with JAB-8263 alone for 4 weeks. The purpose is to evaluate the safety, PK/PD characteristics and preliminary effectiveness of JAB-8263 in participants with active RA.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- JAB-8263
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAB-8263Drug
Variable dose1, orally Q2D with 28 days
JAB-8263Drug
Variable dose2, orally Q2D with 28 days
| Study group | Role | What they receive |
|---|---|---|
| JAB-8263 | Experimental | Not described Receives: Drug: JAB-8263 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the overall safety and tolerability of JAB-8263
Safety assessments including but not limited to Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), deaths and changes in clinical laboratory measures
Measured: Up to approximately 12 weeks
Secondary outcomes (5)
American College of Rheumatology 20 Response Rate (ACR20 Response Rate)
the percentage of patients who meet the ACR20 response criteria
Measured: Up to approximately 12 weeks
American College of Rheumatology 50 Response Rate (ACR50 Response Rate)
the percentage of participants who meet the ACR50 response criteria
Measured: Up to approximately 12 weeks
American College of Rheumatology 70 Response Rate (ACR70 Response Rate)
the percentage of participants who meet the ACR70 response criteria
Measured: Up to approximately 12 weeks
Clinical Disease Activity Index Good Response Rate (CDAI Good Response Rate)
the percentage of participants who achieve a good clinical response based on the Clinical Disease Activity Index (CDAI)
Measured: Up to approximately 12 weeks
Simplified Disease Activity Index Good Response Rate (SDAI Good Response Rate)
the percentage of participants who achieve a good clinical response according to the Simplified Disease Activity Index (SDAI)
Measured: Up to approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start23 Jul 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684157
- Sponsor's protocol ID
- JAB-8263-2001
- Acronym
- JAB-8263
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2026
- Last updated
- 28 Sep 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JAB-8263 in Patients With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07684157
- Acronym / sponsor ID
- JAB-8263 / JAB-8263-2001
- Conditions
- Rheumatoid Arthritis (RA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jul 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.
This study is an open-label, multi-center Phase IIa study. The study is divided into two phases. The first phase is a safety exploration phase. Participants with active rheumatoid arthritis were enrolled and treated with JAB-8263 alone for 4 weeks. The purpose is to evaluate the safety, PK/PD characteristics and preliminary effectiveness of JAB-8263 in participants with active RA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JAB-8263 | Experimental | Drug: JAB-8263 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old and <75 years old at the time of signing the informed consent form, regardless of gender;
- Active rheumatoid arthritis, ESR or C-reactive protein> upper limit of normal
- Meets the 2010 American College of Rheumatology ACR/EULAR RA classification standards
- Participants have recovered from adverse reactions to previous antirheumatic treatment.
Key exclusion criteria (5 listed)
- Use of topical glucocorticoids within 2 weeks before the first dose of investigational product or have received epidural, intraarticular, intramuscular, oral or intravenous glucocorticoids within 4 weeks, and do not use adrenocorticotropin;
- Use of NSAIDs within 1 week before first dose of investigational product
- Known or suspected allergies to the investigational product or any of its components;
- Current active shingles virus infection, including shingles or herpes simplex types 1 and 2 (confirmed by physical examination and medical history); participants had a history of severe herpes infection, including any disseminated disease, shingles in multiple skin areas, herpes encephalitis, ocular herpes, or recurrent shingles (2 episodes greater than or equal to 2 episodes within 2 years);
- Have evidence of active tuberculosis (TB) or have previously had evidence of active TB and have not received appropriate documented treatment;
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 |
|---|---|---|
| JAB-8263Variable dose1, orally Q2D with 28 days | Drug | JAB-8263 |
| JAB-8263Variable dose2, orally Q2D with 28 days | Drug | JAB-8263 |
Primary outcome
Evaluate the overall safety and tolerability of JAB-8263
Time frame: Up to approximately 12 weeks
Safety assessments including but not limited to Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), deaths and changes in clinical laboratory measures
5 secondary outcomes
American College of Rheumatology 20 Response Rate (ACR20 Response Rate)
Time frame: Up to approximately 12 weeks
American College of Rheumatology 50 Response Rate (ACR50 Response Rate)
Time frame: Up to approximately 12 weeks
American College of Rheumatology 70 Response Rate (ACR70 Response Rate)
Time frame: Up to approximately 12 weeks
Clinical Disease Activity Index Good Response Rate (CDAI Good Response Rate)
Time frame: Up to approximately 12 weeks
Simplified Disease Activity Index Good Response Rate (SDAI Good Response Rate)
Time frame: Up to approximately 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 28 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JAB-8263 in people with Rheumatoid Arthritis (RA), run by Jacobio Pharmaceuticals Co., Ltd. at 1 site 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Jun Yang Jun Project Director (86 010-05615464, clinicaltrials@jacobiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the overall safety and tolerability of JAB-8263 (time frame: Up to approximately 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 28 Sep 2026.