Rheumatoid ArthritisPhase 1NCT04457856
A Study of TJ003234 in Rheumatoid Arthritis Patients
A Phase 1 study testing TJ003234 injection in people with Rheumatoid Arthritis, run by I-Mab Biopharma US Limited at 5 sites in China.
Trial summary
Study Purpose and Design: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- TJ003234 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 5 sitesChina
- Study dates
- 6 Aug 2020to Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Subjects must be ≥ 18 and ≤70 years old when signing the informed consent, with no limitation of gender.
- Established Rheumatoid arthritis patients, diagnosed by ACR/EULAR criteria 2010 at least 6 months prior to randomisation.
- Single Ascending Dose: DAS28 score≤3.2. Multiple Ascending Dose: DAS28 score≤5.1 and >3.2.
- Allowed one or more standard treatments, but the start date should no later than 12 weeks(84 days) before the randomisation and should take at a stable dose more than 4 weeks(28 days) before the randomisation. The combination taken of Methotrexate (MTX) and leflunomide was not allowed within 4 weeks (28 days) before randomization.
- Subjects must agree to attendance the study and signed the inform concent by themselves.
- Subjects(include subjects's wife) are no pregnancy plan during the sceering and 3 months after complete the study and agree to use contraceptives that protocol suggest.
Who cannot join
- Employees of the hospital or any other person that paticipant in the study and their immedidte family members.
- A documented history of an autoimmune disease other than RA (other than secondary Sjögren's syndrome) .
- Previous received Any biologic DMARD therapy including tsDMARD. •A positive hepatitis B (HBsAg, anti-HBc, and/or IgM anti-HBc), hepatitis C or HIV test at screening, indicative of a current or past infection.
- A history of active tuberculosis (TB) or positive serological test for TB (Quantiferon TB Gold or T-SPOT).
- Female patients who are pregnant during the study, or are breastfeeding. •Malignancy, or prior malignancy, with a disease free interval of <5 years after diagnosis and intervention except curative treatment for basal and squamous cell skin cancer.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Peking university people's Hospital
Beijing, Beijing Municipality, 10044
Zhanguo Li, +86010-88326666, li99@bjmu.edu.cn
- Recruiting
The first affiliated hospital of bengbu medical college
Bengbu, Anhui
Zhijun Li, 13955289810, lizhijundr@126.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Lingyun Sun, 13705186409, lingyunsun2012@163.com
- Recruiting
Zhongda Hospital southeast university
Nanjing, Jiangsu
Meimei Wang, 13505167748, wmm3272142@163.com
- Recruiting
FuDan University shanghai huashan Hospital
Shanghai, Shanghai Municipality
Yu Xue, 18918760187, 18121186087@163.com
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients
Study Purpose and Design: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients.
- Conditions
- Rheumatoid Arthritis
- Being tested
- TJ003234 injection
- Keywords
- Rheumatoid Arthritis, biologics
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ003234 injectionBiological
Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks)
| Study group | Role | What they receive |
|---|---|---|
| TJ003234 | Experimental | Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) Mode of administration: The investigational drug is administered by intravenous infusion Receives: Biological: TJ003234 injection |
| Placebo | Placebo comparator | Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) Mode of administration: The investigational drug is administered by intravenous infusion Receives: Biological: TJ003234 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subject with adverse events(AEs)
Number of subject with adverse events(AEs) to evaluate satety in patient with RA with vital signs, Electrocardiograms, physical examinations, laboratory tests and respiratory-related examinations
Measured: First dose up to last follow-up visit (i.e. 90 days after dosing for single dose part, 140 days after first dose for multiple dose part)
Secondary outcomes (5)
AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234
AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234
Measured: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
Maximum observed plasma concentration (Cmax) of TJ003234
Maximum observed plasma concentration (Cmax) of TJ003234
Measured: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
The proportion of subjects who produce anti-drug antibodies
The proportion of subjects who produce anti-drug antibodies
Measured: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
The proportion of subjects who produce neutralizing antibodies
The proportion of subjects who produce neutralizing antibodies
Measured: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies
The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies
Measured: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start6 Aug 2020
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-blind, Placebo-controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I-Mab Biopharma US Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457856
- Sponsor's protocol ID
- TJ003234RAR102
- Status last verified
- Aug 2022
- First submitted
- 28 Jun 2020
- Last updated
- 3 Aug 2022
- 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 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT04457856
- Acronym / sponsor ID
- TJ003234RAR102
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, biologics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- I-Mab Biopharma US LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 7 Jul 2020 (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.
Study Purpose and Design: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, Double-blind, Placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| TJ003234 | Experimental | Biological: TJ003234 injectionIntravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) Mode of administration: The investigational drug is administered by intravenous infusion |
| Placebo | Placebo comparator | Biological: TJ003234 injectionIntravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) Mode of administration: The investigational drug is administered by intravenous infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be ≥ 18 and ≤70 years old when signing the informed consent, with no limitation of gender.
- Established Rheumatoid arthritis patients, diagnosed by ACR/EULAR criteria 2010 at least 6 months prior to randomisation.
- Single Ascending Dose: DAS28 score≤3.2. Multiple Ascending Dose: DAS28 score≤5.1 and >3.2.
- Allowed one or more standard treatments, but the start date should no later than 12 weeks(84 days) before the randomisation and should take at a stable dose more than 4 weeks(28 days) before the randomisation. The combination taken of Methotrexate (MTX) and leflunomide was not allowed within 4 weeks (28 days) before randomization.
- Subjects must agree to attendance the study and signed the inform concent by themselves.
Key exclusion criteria (5 listed)
- Employees of the hospital or any other person that paticipant in the study and their immedidte family members.
- A documented history of an autoimmune disease other than RA (other than secondary Sjögren's syndrome) .
- Previous received Any biologic DMARD therapy including tsDMARD. •A positive hepatitis B (HBsAg, anti-HBc, and/or IgM anti-HBc), hepatitis C or HIV test at screening, indicative of a current or past infection.
- A history of active tuberculosis (TB) or positive serological test for TB (Quantiferon TB Gold or T-SPOT).
- Female patients who are pregnant during the study, or are breastfeeding. •Malignancy, or prior malignancy, with a disease free interval of <5 years after diagnosis and intervention except curative treatment for basal and squamous cell skin cancer.
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 |
|---|---|---|
| TJ003234 injectionIntravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) | Biological | Placebo, TJ003234 |
Primary outcome
Number of subject with adverse events(AEs)
Time frame: First dose up to last follow-up visit (i.e. 90 days after dosing for single dose part, 140 days after first dose for multiple dose part)
Number of subject with adverse events(AEs) to evaluate satety in patient with RA with vital signs, Electrocardiograms, physical examinations, laboratory tests and respiratory-related examinations
5 secondary outcomes
AUC from time 0 to the time of the last quantifiable concentration AUC0-tlast of TJ003234
Time frame: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
Maximum observed plasma concentration (Cmax) of TJ003234
Time frame: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
The proportion of subjects who produce anti-drug antibodies
Time frame: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
The proportion of subjects who produce neutralizing antibodies
Time frame: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
The proportion of subjects who produce the titers of anti-drug antibodies and neutralizing antibodies
Time frame: Day1 to 90 days after dosing for single dose part, 140 days after for multiple dose part
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- 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. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TJ003234 injection in people with Rheumatoid Arthritis, run by I-Mab Biopharma US Limited at 5 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 6 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: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhanguo Li (+86010-88326666, li99@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subject with adverse events(AEs) (time frame: First dose up to last follow-up visit (i.e. 90 days after dosing for single dose part, 140 days after first dose for multiple dose part)). 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 3 Aug 2022.