Rheumatoid ArthritisPhase 3NCT04077567
An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis
A Phase 3 study testing TS-152 in people with Rheumatoid Arthritis, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To evaluate the long-term safety and efficacy of TS-152 in subjects with Rheumatoid Arthritis who have completed the previous study (TS152-3000-JA study or TS152-3001-JA study). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- TS-152
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 1 siteJapan
- Study dates
- 1 Oct 2019to 28 Apr 2023
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At visit1(-4 weeks), Subject must be fully informed about the study and must obtain written informed consent from the subject himself.
- At Visit2(0 week), Subjects must have completed the previous study (TS152-3000-JA or TS152-3001-JA) ,and must have completed all evaluations required at the follow-up visit.
- etc.
Who cannot join
- Subjects who had serious adverse drug reactions in the previous study.
- At Visit1(-4 weeks) or Visit2 (0 week), Subjects who have not recovered from clinically important adverse events.
- etc.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the long-term safety and efficacy of TS-152 in subjects with Rheumatoid Arthritis who have completed the previous study (TS152-3000-JA study or TS152-3001-JA study).
- Conditions
- Rheumatoid Arthritis
- Being tested
- TS-152
- Keywords
- RA
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-152Drug
Also called ozoralizumab
30mg,80mg
| Study group | Role | What they receive |
|---|---|---|
| TS-152 30mg SC | Experimental | TS-152 30mg subcutaneously (SC) every 4 weeks Receives: Drug: TS-152 |
| TS-152 80mg SC | Experimental | TS-152 80mg subcutaneously (SC) every 4 weeks Receives: Drug: TS-152 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
To evaluate the Long-term safety of TS-152 in RA patients by incidence of adverse events which include vital signs, and clinical laboratory parameters.
Measured: through study completion, an average of 3 year
ACR20
Percentage of Subjects who meet the American College of Rheumatology 20% (ACR20) Criteria from baseline of previous study (TS152-3001-JA or TS152-3001-JA).
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Oct 2019
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077567
- Sponsor's protocol ID
- TS152-3002-JA
- Status last verified
- May 2023
- First submitted
- 29 Aug 2019
- Last updated
- 28 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tanaka Y, Miyazaki Y, Kawanishi M, Yamasaki H, Takeuchi T. Long-term safety and efficacy of anti-TNF multivalent VHH antibodies ozoralizumab in patients with rheumatoid arthritis. RMD Open. 2024 Aug 22;10(3):e004480. doi: 10.1136/rmdopen-2024-004480.
PubMed 39179257
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04077567
- Acronym / sponsor ID
- TS152-3002-JA
- Conditions
- Rheumatoid Arthritis
- Keywords
- RA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 4 Sep 2019 (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.
To evaluate the long-term safety and efficacy of TS-152 in subjects with Rheumatoid Arthritis who have completed the previous study (TS152-3000-JA study or TS152-3001-JA study).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TS-152 30mg SC | Experimental | Drug: TS-152TS-152 30mg subcutaneously (SC) every 4 weeks |
| TS-152 80mg SC | Experimental | Drug: TS-152TS-152 80mg subcutaneously (SC) every 4 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At visit1(-4 weeks), Subject must be fully informed about the study and must obtain written informed consent from the subject himself.
- At Visit2(0 week), Subjects must have completed the previous study (TS152-3000-JA or TS152-3001-JA) ,and must have completed all evaluations required at the follow-up visit.
- etc.
Key exclusion criteria (3 listed)
- Subjects who had serious adverse drug reactions in the previous study.
- At Visit1(-4 weeks) or Visit2 (0 week), Subjects who have not recovered from clinically important adverse events.
- etc.
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 |
|---|---|---|
| TS-152Also: ozoralizumab30mg,80mg | Drug | TS-152 30mg SC, TS-152 80mg SC |
Primary outcome
Incidence of adverse events
Time frame: through study completion, an average of 3 year
To evaluate the Long-term safety of TS-152 in RA patients by incidence of adverse events which include vital signs, and clinical laboratory parameters.
ACR20
Time frame: through study completion, an average of 3 year
Percentage of Subjects who meet the American College of Rheumatology 20% (ACR20) Criteria from baseline of previous study (TS152-3001-JA or TS152-3001-JA).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Results publication: PubMed 39179257Tanaka Y, Miyazaki Y, Kawanishi M, Yamasaki H, Takeuchi T. Long-term safety and efficacy of anti-TNF multivalent VHH antibodies ozoralizumab in patients with rheumatoid arthritis. RMD Open. 2024 Aug 22;10(3):e004480. doi: 10.1136/rmdopen-2024-004480.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TS-152 in people with Rheumatoid Arthritis, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 28 Feb 2025. 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 Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: through study completion, an average of 3 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04077567, which also lists 1 linked publication.
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 Feb 2025.