Rheumatoid ArthritisPhase 3NCT06887127
A Long-term Extension Clinical Study of TLL-018 in Patients With Rheumatoid Arthritis
A Phase 3 study testing TLL-018 in people with Rheumatoid Arthritis, run by Hangzhou Highlightll Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of TLL-018 in patients with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with TLL-018. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- TLL-018
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2025to 31 Dec 2027
- Phase
- Phase 3
- 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
- Subjects have completed TLL-018-301 study within 3 months;
- Age (at the time of consent):>＝18 years of age, <＝75 years of age;
- Female subjects of childbearing potential (WOCBP), who should not be pregnant or breastfeeding, should not enter the study until after pregnancy testing (e.g., HCG beta subunit-based monitoring);
- All subjects and their partners voluntarily use contraception as deemed effective by the investigator for at least 90 days from the first dose of the investigational drug to the last dose of the investigational drug (Appendix I); no sperm or egg donation is planned by the subject for at least 6 months from the screening period to the last dose of the investigational drug.
- Subjects can understand the informed consent form, volunteer to participate in the study and sign the informed consent form.
Who cannot join
- Subjects have had severe allergic reaction related to the investigational drug during the TLL-018-301 study;
- Subjects have had herpes zoster, a major cardiovascular event (MACE), thromboembolism, or lymphoproliferative disorders from the time of TLL-018-301 study to the screening of OLE study;
- Subjects have a clinically significant cardiovascular, respiratory, or any other serious and/or non-stable disease, and there is security risk for subjects to participate in this study judged by the investigator;
- Subjects have abnormal and clinically significant laboratory test values at screening;
- Subjects who have taken traditional Chinese medicines, csDMARDs, immunosuppressive drugs, potent opioids, and other JAK inhibitors (except the investigational drugs in TLL-018-301 study) within 1 week before taking the first dose of the investigational drug in OLE study;
- Subjects have treated with flunomide, any bDMARDs, interferon, and other injected immunosuppressive drugs from TLL-018-301 study to the screening of OLE study;
- Subjects who have received any live vaccine within 2 months prior to taking the first dose of the investigational drug or who plan to receive a live vaccine during the study;
- Subjects have had active tuberculosis infection without evidence of clinical cure; have suspected tuberculosis symptoms judged by the investigator; have latent tuberculosis infection (LTBI) but not received preventive treatment regimens within 3 years prior to screening or not completed a course of therapy.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100022
About this study
Official title: An Open-label, Long-term Extension Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of TLL-018 in Patients With Rheumatoid Arthritis
The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of TLL-018 in patients with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with TLL-018.
Read the detailed description
This is an open-label extension study to assess the long-term safety, tolerability, and efficacy of TLL-018 in adults with RA who have completed Study TLL-018-301(NCT06020144), a phase 3 randomized controlled trial with TLL-018.
The study includes three parts: screening period, treatment period and follow-up period. All participants will be treated with TLL-018 20 mg twice daily (BID) for 78 weeks.
Safety assessment will be conducted at 6, 12, 24, 36, 48, 60, 72, 78 weeks, including physical examination, collection of vital signs, laboratory tests, AEs, SAEs, etc.
Efficacy evaluation will be performed at weeks 12, 24, 36, 48, 60, 72, and 78, including joint assessment, PGA, PtGA, VAS, HAQ-DI questionnaires, SF-36 scale, morning stiffness assessment, DAS28-hsCRP, CDAI, SDAI, ACR20/50/70 response assessment.
- Conditions
- Rheumatoid Arthritis
- Being tested
- TLL-018
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLL-018Drug
TLL-018 20 mg BID for 78 weeks
| Study group | Role | What they receive |
|---|---|---|
| TLL-018 | Experimental | Participants received a two-stage treatment period in Study TLL-018-301, with treatment of 24 weeks of TLL-018 20 mg BID or tofacitinib 5 mg BID in Stage 1. In Stage 2, the participants with tofacitinib who didn't achieve ACR50 were transferred to TLL-018, and other participants maintained the original treatment. Upon completion of Study TLL-018-301, qualified participants can enter the OLE study, and all participants will receive TLL-018 20 mg BID, i.e., 2 tablets of TLL-018 10 mg orally twice daily, for 78 weeks. Receives: Drug: TLL-018 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of occurrences and Percentage of Participants with AEs and SAEs
Evaluation includes vital signs, physical examination, ECG examination, laboratory tests, AE, SAE, etc.
Measured: At Weeks 6, 12, 24, 36, 48, 60, 72, 78
Secondary outcomes (14)
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
>=50% improvement in 68-tender joint count; >=50% improvement in 66-swollen joint count; >=50% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).
Measured: At Weeks 12, 24, 36, 48, 60, 72, 78
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
>=20% improvement in 68-tender joint count; >=20% improvement in 66-swollen joint count; >=20% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).
Measured: At Weeks 12, 24, 36, 48, 60, 72, 78
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
>=70% improvement in 68-tender joint count; >=70% improvement in 66-swollen joint count; >=70% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).
Measured: At Weeks 12, 24, 36, 48, 60, 72, 78
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Disease Activity Score (DAS) based on a 28 joint count hsCRP consisted of composite numerical score of following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and participant's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP equals to (=) 0.56*square root (sqrt) (TJC28) plus (+) 0.28*sqrt (SJC28) + 0.36*natural log(hsCRP+1) + 0.014*participant's global assessment of disease activity + 0.96. Scores ranged 0-9.4, where lower scores indicated less disease activity.
Measured: At Weeks 12, 24, 36, 48, 60, 72, 78
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity.
Clinical remission is defined as a DAS28(CRP) score < 2.6.
Measured: At Weeks 12, 24, 36, 48, 60, 72, 78
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
The disease activity score-28-CRP (DAS28 [CRP]) assesses RA disease activity based on a continuous scale of combined measures of 28 tender joint counts (TJC28), 28 swollen joint counts (SJC28), C-reactive protein (CRP), and the patient global assessment of disease activity (measured on a visual analog scale from 0 to 100 mm). DAS28(CRP) scores range from 0 to approximately 10 where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Measured: Baseline (of the preceding TLL-018-301 study）and Weeks 12, 24, 36, 48, 60, 72, 78
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
Measured: Baseline (of the preceding TLL-018-301 study）and Weeks 12, 24, 36, 48, 60, 72, 78
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Measured: Baseline (of the preceding TLL-018-301 study）and Weeks 12, 24, 36, 48, 60, 72, 78
Change From Baseline in Simplified Disease Activity Index (SDAI) Over Time
The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Measured: Baseline (of the preceding TLL-018-301 study）and Weeks 12, 24, 36, 48, 60, 72, 78
Change From Baseline in Patient's Assessment of Pain Over Time
Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale from 0 to 100 mm. A score of 0 mm indicates "no pain" and a score of 100 mm indicates "worst possible pain."
Measured: Baseline (of the preceding 301 study）and Weeks 12, 24, 36, 48, 60, 72, 78
Change From Baseline in Patient's Global Assessment of Disease Activity (PtGA) Over Time
The participant was asked to rate their current RA disease activity over the past 24 hours on a 100 mm VAS, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity.
Measured: Baseline (of the preceding TLL-018-301 study）and Weeks 12, 24, 36, 48, 60, 72, 78
Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Changes From Baseline in SF-36 Score
The physician rated the participant's current global RA disease activity (independently from the participant's assessment) on a visual analog scale (VAS) from 0 to 100 mm, where 0 mm indicates no disease activity and 100 mm indicates severe disease activity.
Measured: Baseline (of the preceding TLL-018-301 study）and Weeks 12, 24, 36, 48, 60, 72, 78
Changes From Baseline in SF-36 Score Over Time
SF-36 score was an evaluation of the functional status for a participant,taping eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Coded numeric values are recoded per the scoring key. All items are scored so that a high score defines a more favorable health state. Each item is scored on a o to 100 range. Items in the same scale are averaged together to create the 8 scale scores.
Measured: Baseline (of the preceding TLL-018-301 study）and Weeks 24, 48, 78
Changes From Baseline in Morning Stiffness Over Time
The VAS is a 100 mm line ranging from 0 mm (no morning stiffness) on the left end and 100 mm (worst morning stiffness) on the right end. Subjects marked on the line to indicate their pain severity. The distance in mm was measured from the left end to the subject's marking. Duration of morning stiffness will be from wake-up time to time of resolution of morning stiffness.
Measured: Baseline (of the preceding TLL-018-301 study）and Weeks 24, 48, 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start10 Mar 2025
- Primary completion31 Dec 2026 (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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Highlightll Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887127
- Sponsor's protocol ID
- TLL-018-304
- Status last verified
- Sep 2026
- First submitted
- 14 Mar 2025
- Last updated
- 25 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Long-term Extension Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of TLL-018 in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06887127
- Acronym / sponsor ID
- TLL-018-304
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Hangzhou Highlightll Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Mar 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 primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of TLL-018 in patients with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with TLL-018.
Detailed description
This is an open-label extension study to assess the long-term safety, tolerability, and efficacy of TLL-018 in adults with RA who have completed Study TLL-018-301(NCT06020144), a phase 3 randomized controlled trial with TLL-018.
The study includes three parts: screening period, treatment period and follow-up period. All participants will be treated with TLL-018 20 mg twice daily (BID) for 78 weeks.
Safety assessment will be conducted at 6, 12, 24, 36, 48, 60, 72, 78 weeks, including physical examination, collection of vital signs, laboratory tests, AEs, SAEs, etc.
Efficacy evaluation will be performed at weeks 12, 24, 36, 48, 60, 72, and 78, including joint assessment, PGA, PtGA, VAS, HAQ-DI questionnaires, SF-36 scale, morning stiffness assessment, DAS28-hsCRP, CDAI, SDAI, ACR20/50/70 response assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TLL-018 | Experimental | Drug: TLL-018Participants received a two-stage treatment period in Study TLL-018-301, with treatment of 24 weeks of TLL-018 20 mg BID or tofacitinib 5 mg BID in Stage 1. In Stage 2, the participants with tofacitinib who didn't achieve ACR50 were transferred to TLL-018, and other participants maintained the original treatment. Upon completion of Study TLL-018-301, qualified participants can enter the OLE study, and all participants will receive TLL-018 20 mg BID, i.e., 2 tablets of TLL-018 10 mg orally twice daily, for 78 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects have completed TLL-018-301 study within 3 months;
- Age (at the time of consent):>＝18 years of age, <＝75 years of age;
- Female subjects of childbearing potential (WOCBP), who should not be pregnant or breastfeeding, should not enter the study until after pregnancy testing (e.g., HCG beta subunit-based monitoring);
- All subjects and their partners voluntarily use contraception as deemed effective by the investigator for at least 90 days from the first dose of the investigational drug to the last dose of the investigational drug (Appendix I); no sperm or egg donation is planned by the subject for at least 6 months from the screening period to the last dose of the investigational drug.
- Subjects can understand the informed consent form, volunteer to participate in the study and sign the informed consent form.
Key exclusion criteria (8 listed)
- Subjects have had severe allergic reaction related to the investigational drug during the TLL-018-301 study;
- Subjects have had herpes zoster, a major cardiovascular event (MACE), thromboembolism, or lymphoproliferative disorders from the time of TLL-018-301 study to the screening of OLE study;
- Subjects have a clinically significant cardiovascular, respiratory, or any other serious and/or non-stable disease, and there is security risk for subjects to participate in this study judged by the investigator;
- Subjects have abnormal and clinically significant laboratory test values at screening;
- Subjects who have taken traditional Chinese medicines, csDMARDs, immunosuppressive drugs, potent opioids, and other JAK inhibitors (except the investigational drugs in TLL-018-301 study) within 1 week before taking the first dose of the investigational drug in OLE 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 |
|---|---|---|
| TLL-018TLL-018 20 mg BID for 78 weeks | Drug | TLL-018 |
Primary outcome
Number of occurrences and Percentage of Participants with AEs and SAEs
Time frame: At Weeks 6, 12, 24, 36, 48, 60, 72, 78
Evaluation includes vital signs, physical examination, ECG examination, laboratory tests, AE, SAE, etc.
14 secondary outcomes
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Time frame: At Weeks 12, 24, 36, 48, 60, 72, 78
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Time frame: At Weeks 12, 24, 36, 48, 60, 72, 78
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Time frame: At Weeks 12, 24, 36, 48, 60, 72, 78
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Time frame: At Weeks 12, 24, 36, 48, 60, 72, 78
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Time frame: At Weeks 12, 24, 36, 48, 60, 72, 78
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Time frame: Baseline (of the preceding TLL-018-301 study）and Weeks 12, 24, 36, 48, 60, 72, 78
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Time frame: Baseline (of the preceding TLL-018-301 study）and Weeks 12, 24, 36, 48, 60, 72, 78
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Time frame: Baseline (of the preceding TLL-018-301 study）and Weeks 12, 24, 36, 48, 60, 72, 78
Change From Baseline in Simplified Disease Activity Index (SDAI) Over Time
Time frame: Baseline (of the preceding TLL-018-301 study）and Weeks 12, 24, 36, 48, 60, 72, 78
Change From Baseline in Patient's Assessment of Pain Over Time
Time frame: Baseline (of the preceding 301 study）and Weeks 12, 24, 36, 48, 60, 72, 78
Change From Baseline in Patient's Global Assessment of Disease Activity (PtGA) Over Time
Time frame: Baseline (of the preceding TLL-018-301 study）and Weeks 12, 24, 36, 48, 60, 72, 78
Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Changes From Baseline in SF-36 Score
Time frame: Baseline (of the preceding TLL-018-301 study）and Weeks 12, 24, 36, 48, 60, 72, 78
Changes From Baseline in SF-36 Score Over Time
Time frame: Baseline (of the preceding TLL-018-301 study）and Weeks 24, 48, 78
Changes From Baseline in Morning Stiffness Over Time
Time frame: Baseline (of the preceding TLL-018-301 study）and Weeks 24, 48, 78
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 25 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. 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 TLL-018 in people with Rheumatoid Arthritis, run by Hangzhou Highlightll Pharmaceutical 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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 25 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 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?
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?
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?
Number of occurrences and Percentage of Participants with AEs and SAEs (time frame: At Weeks 6, 12, 24, 36, 48, 60, 72, 78). 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 25 Sep 2026.