ClinicalTrials.gg
RecruitingNCT07684157JAB-8263Updated Sep 28, 2026

A Phase IIa Study of JAB-8263 in Patients With Active Rheumatoid Arthritis

A Phase 2 interventional study of JAB-8263 and JAB-8263 in Rheumatoid Arthritis (RA), sponsored by Jacobio Pharmaceuticals Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Jacobio Pharmaceuticals Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Updated Sep 28, 2026Now RecruitingSite recruiting status changed+3 moreGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 249 studies in Arthritis, Rheumatoid with a site in China — 63 open to participants now, 72 under way, 3 of them phase 3. Arthritis, Rheumatoid · China.

Planned enrollment
172nd of 217
32 · median 134
Started
2026
with 18 others
Phase 2
34 of 249
8 open now
Primary completion
2027-06
later than 41 of 71 live
Registered
245th of 249
by date

Among the 249 studies in Arthritis, Rheumatoid with a site in China, this one is the 172nd largest by planned enrollment of the 217 interventional ones that give a count, is one of 19 that started in 2026, is one of 34 in phase 2, reaches primary completion later than 41 of the 71 other live ones, and was the 245th registered.

Arthritis, Rheumatoid

3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.

Browse Arthritis, Rheumatoid studies →

Open to participants now

63 of the 249 studies in Arthritis, Rheumatoid with a site in China are open now. Recruiting first, the newest first:

57 more — sign in →

All 63 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 249 studies in Arthritis, Rheumatoid with a site in China, or all of them as a file.
02

Study 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. The purpose is to evaluate the safety, PK/PD characteristics and preliminary effectiveness of JAB-8263 in participants with active RA.

03

Conditions studied

  • Rheumatoid Arthritis (RA)
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥18 years old and \<75 years old at the time of signing the form, regardless of gender;
  2. Active rheumatoid arthritis, ESR or C-reactive protein>
  3. Meets the 2010 American College of Rheumatology ACR/EULAR RA classification standards
  4. Participants have recovered from adverse reactions to previous antirheumatic treatment.

Exclusion criteria

Exclusion Criteria:

  1. Use of topical within 2 weeks before the first dose of product or have received epidural, intraarticular, intramuscular, oral or intravenous glucocorticoids within 4 weeks, and do not use adrenocorticotropin;
  2. Use of NSAIDs within 1 week before first dose of investigational product
  3. Known or suspected allergies to the investigational product or any of its components;
  4. 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);
  5. Have evidence of active tuberculosis (TB) or have previously had evidence of active TB and have not received appropriate documented treatment;
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    JAB-8263

    Drug: JAB-8263

Interventions

  • Variable dose1, orally Q2D with 28 days

  • Variable dose2, orally Q2D with 28 days

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to approximately 12 weeks

Secondary outcomes

  1. American College of Rheumatology 20 Response Rate (ACR20 Response Rate)

    the percentage of patients who meet the ACR20 response criteria

    Time frame: Up to approximately 12 weeks

  2. American College of Rheumatology 50 Response Rate (ACR50 Response Rate)

    the percentage of participants who meet the ACR50 response criteria

    Time frame: Up to approximately 12 weeks

  3. American College of Rheumatology 70 Response Rate (ACR70 Response Rate)

    the percentage of participants who meet the ACR70 response criteria

    Time frame: Up to approximately 12 weeks

  4. 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)

    Time frame: Up to approximately 12 weeks

  5. 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)

    Time frame: Up to approximately 12 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Jun 2027, 11 months after the start.

Of 116 industry-sponsored phase 2 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 24. This study's planned 11 months is below that.

Counting every sponsor, half of 158 studies reached it within 18 months; a quarter within 13 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2026
First posted
Jul 6, 2026
StartActual
Jul 23, 2026
Primary completionEst.
Jun 30, 2027
CompletionEst.
Dec 31, 2027
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Sep 28, 2026
Sites
Beijing Hospital is now Recruiting
Sep 28, 2026
Start date
Jul 29, 2026→Jul 23, 2026 (actual)
Sep 28, 2026
Primary outcomes
1 time frame changed, 1 description edited
What changed in the outcomes
  • Time frameEvaluate the overall safety and tolerability of JAB-8263Up to approximately 12week → Up to approximately 12 weeks
  • DescriptionEvaluate the overall safety and tolerability of JAB-8263: how it is measured was reworded
Sep 28, 2026
Secondary outcomes
5 time frame changed
What changed in the outcomes
  • Time frameAmerican College of Rheumatology 20 Response Rate (ACR20 Response Rate)Up to approximately 12week → Up to approximately 12 weeks
  • Time frameAmerican College of Rheumatology 50 Response Rate (ACR50 Response Rate)Up to approximately 12week → Up to approximately 12 weeks
  • Time frameAmerican College of Rheumatology 70 Response Rate (ACR70 Response Rate)Up to approximately 12week → Up to approximately 12 weeks
  • Time frameClinical Disease Activity Index Good Response Rate (CDAI Good Response Rate)Up to approximately 12week → Up to approximately 12 weeks
  • Time frameSimplified Disease Activity Index Good Response Rate (SDAI Good Response Rate)Up to approximately 12week → Up to approximately 12 weeks
Sep 28, 2026
Contact
Study contact's phone or email changed: none listed→•••5464. See the current contact
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Not yet recruiting→Recruiting
    Beijing Hospital is now Recruiting
    Start date Jul 29, 2026→Jul 23, 2026 (now actual)
    Primary outcomes 1 time frame changed, 1 description edited
    What changed in the outcomes
    • Time frameEvaluate the overall safety and tolerability of JAB-8263Up to approximately 12week → Up to approximately 12 weeks
    • DescriptionEvaluate the overall safety and tolerability of JAB-8263: how it is measured was reworded
    Secondary outcomes 5 time frame changed
    What changed in the outcomes
    • Time frameAmerican College of Rheumatology 20 Response Rate (ACR20 Response Rate)Up to approximately 12week → Up to approximately 12 weeks
    • Time frameAmerican College of Rheumatology 50 Response Rate (ACR50 Response Rate)Up to approximately 12week → Up to approximately 12 weeks
    • Time frameAmerican College of Rheumatology 70 Response Rate (ACR70 Response Rate)Up to approximately 12week → Up to approximately 12 weeks
    • Time frameClinical Disease Activity Index Good Response Rate (CDAI Good Response Rate)Up to approximately 12week → Up to approximately 12 weeks
    • Time frameSimplified Disease Activity Index Good Response Rate (SDAI Good Response Rate)Up to approximately 12week → Up to approximately 12 weeks
    Contact Study contact's phone or email changed: none listed→•••5464. See the current contact
    + 4 other changes: identifiers, verification date, design details and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07684157
Lead sponsor
Jacobio Pharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Jul 6, 2026
Start date
Jul 23, 2026
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 28, 2026

Study contacts

Jun Yang Jun Project Director
Contact
clinicaltrials@jacobiopharma.com
86 010-05615464

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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