Gout TophusEarly Phase 1NCT05800041
A Exploratory Trial of WTX221 in Refractory Gout Patients
A Early Phase 1 study testing WTX221 in people with Gout Tophus, run by RenJi Hospital.
Trial summary
This trial is a single-center, open-label designed investigator-initiated clinical study (IIT) to investigate the safety, tolerability, PK, PD, immunogenicity, and preliminary efficacy of multiple doses of WTX221 infusion combined with a single dose of the immunosuppressive agent cyclophosphamide (CTX) to induce… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout Tophus
- What is being tested?
- WTX221
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2023to 1 Feb 2024
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the informed consent form, and be able to complete all trial processes as required by the protocol;
- Subject is ≥ 18 years of age;
- Patients with refractory gout: multiple tophi, more than 2 sites;
- Subjects (males and females) must agree to be free of childbearing potential and willing to use effective contraception with their partner and have no plans to donate sperm or eggs during the trial and for at least 1 year after the infusion.
Who cannot join
- Patients with allergic diseases or specific allergic history, or possible allergic to the study drug and any of its components or related preparations;
- Patients unable to communicate or cooperate with medical staff due to neurological, mental illness or language disorder, which affects patient compliance;
- Having any past or present medical history that may affect the safety of the trial or the in vivo process of the drug, especially history of cardiovascular, liver, kidney, digestive tract, lung, spleen, nerve, blood, tumor, immune or metabolic disorders that are considered clinically significant by the investigator;
- Participated in other drug or medical device clinical trials within 3 months before screening;
- Patients who have received intravenous anti-infective treatment or active infection within 14 days before administration;
- Patients with history of allogeneic organ, bone marrow transplantation or stem cell transplantation;
- Patients with laboratory abnormalities that are clinically significant:
- The investigator believes that it will prevent the subject from following and completing any other circumstances of the study protocol;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Exploratory Trial to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Immunogenicity, and Preliminary Efficacy of WTX221 Infusion in Patients With Refractory Gout
This trial is a single-center, open-label designed investigator-initiated clinical study (IIT) to investigate the safety, tolerability, PK, PD, immunogenicity, and preliminary efficacy of multiple doses of WTX221 infusion combined with a single dose of the immunosuppressive agent cyclophosphamide (CTX) to induce immune tolerance.
The trial consisted of a Screening Period (14 days), a First Dose Period (30 days), a Second Dose Period (30 days), and a Safety Follow-up Period (150 days) for a total of 224 days.
Read the detailed description
Refractory gout is usually associated with persistently swollen and tender joints, chronic pain, reduced functional status, impaired quality of life, and joint destruction，most of the patients can't tolerate urate-lowering therapy(ULT)or receive adequate dose of ULT treatment recommended to control Serum uric acid (SUA) to target level.
WTX221 is designed to induce antigen-specific immune tolerance. WTX221 is made of urate oxidase(UOX) molecules conjugated on the surface of Red blood cells(RBCs), which can induce antigen-specific immune tolerance to UOX in vivo by making use of it's natural biologic characteristics. WTX221 infusion combined with a single dose CTX to induce immune tolerance.
The trial consisted of a Screening Period (14 days), a First Dose Period (30 days), a Second Dose Period (30 days), and a Safety Follow-up Period (150 days) for a total of 224 days.
- Conditions
- Gout Tophus
- Being tested
- WTX221
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WTX221Drug
Also called cyclophosphamide
Drug: WTX221 WTX221 infusion once every 30 days for two doses in total Drug: CTX Co-administration of CTX and WTX221 at the initial infusion
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | WTX221 low dose Receives: Drug: WTX221 |
| Treatment group B | Experimental | WTX221middle dose Receives: Drug: WTX221 |
| Treatment group C | Experimental | WTX221 high dose Receives: Drug: WTX221 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of multiple doses of WTX221 infusion combined with a single dose of cyclophosphamide in patients with refractory gout.
Adverse Events and Serious Adverse Events
Measured: from the first WTX221 infusion to 210 days
Secondary outcomes (4)
To evaluate the pharmacokinetic (PK) profile of multiple doses of WTX221 infusion combined with a single dose of cyclophosphamide in patients with refractory gout;
Functional protein content in blood (PK)
Measured: from the first WTX221 infusion to 210 days
To evaluate the pharmacodynamic (PD) profile of multiple doses of WTX221 infusion combined with a single dose of cyclophosphamide in patients with refractory gout
plasma uric acid(UA) level
Measured: from the first WTX221 infusion to 210 days
To evaluate the preliminary efficacy of multiple doses of WTX221 infusion combined with a single dose of cyclophosphamide in patients with refractory gout
plasma UA level < 360 umol/L
Measured: from the first WTX221 infusion to 60days Number of gout flares in subjects (within 60 days);
To evaluate immunogenicity (ADA) levels of multiple doses of WTX221 infusion combined with a single dose of cyclophosphamide in patients with refractory gout
ADA incidence rate
Measured: from the first WTX221 infusion to 210days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start10 Apr 2023 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout TophusStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Westlake Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800041
- Sponsor's protocol ID
- Evolve-101
- Status last verified
- Mar 2023
- First submitted
- 23 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Exploratory Trial to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Immunogenicity, and Preliminary Efficacy of WTX221 Infusion in Patients With Refractory Gout
- ClinicalTrials.gov ID
- NCT05800041
- Acronym / sponsor ID
- Evolve-101
- Conditions
- Gout Tophus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Westlake Therapeutics
- Study start
- 10 Apr 2023 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 5 Apr 2023 (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 trial is a single-center, open-label designed investigator-initiated clinical study (IIT) to investigate the safety, tolerability, PK, PD, immunogenicity, and preliminary efficacy of multiple doses of WTX221 infusion combined with a single dose of the immunosuppressive agent cyclophosphamide (CTX) to induce immune tolerance.
The trial consisted of a Screening Period (14 days), a First Dose Period (30 days), a Second Dose Period (30 days), and a Safety Follow-up Period (150 days) for a total of 224 days.
Detailed description
Refractory gout is usually associated with persistently swollen and tender joints, chronic pain, reduced functional status, impaired quality of life, and joint destruction，most of the patients can't tolerate urate-lowering therapy(ULT)or receive adequate dose of ULT treatment recommended to control Serum uric acid (SUA) to target level.
WTX221 is designed to induce antigen-specific immune tolerance. WTX221 is made of urate oxidase(UOX) molecules conjugated on the surface of Red blood cells(RBCs), which can induce antigen-specific immune tolerance to UOX in vivo by making use of it's natural biologic characteristics. WTX221 infusion combined with a single dose CTX to induce immune tolerance.
The trial consisted of a Screening Period (14 days), a First Dose Period (30 days), a Second Dose Period (30 days), and a Safety Follow-up Period (150 days) for a total of 224 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: WTX221WTX221 low dose |
| Treatment group B | Experimental | Drug: WTX221WTX221middle dose |
| Treatment group C | Experimental | Drug: WTX221WTX221 high dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the informed consent form, and be able to complete all trial processes as required by the protocol;
- Subject is ≥ 18 years of age;
- Patients with refractory gout: multiple tophi, more than 2 sites;
- Subjects (males and females) must agree to be free of childbearing potential and willing to use effective contraception with their partner and have no plans to donate sperm or eggs during the trial and for at least 1 year after the infusion.
Key exclusion criteria (8 listed)
- Patients with allergic diseases or specific allergic history, or possible allergic to the study drug and any of its components or related preparations;
- Patients unable to communicate or cooperate with medical staff due to neurological, mental illness or language disorder, which affects patient compliance;
- Having any past or present medical history that may affect the safety of the trial or the in vivo process of the drug, especially history of cardiovascular, liver, kidney, digestive tract, lung, spleen, nerve, blood, tumor, immune or metabolic disorders that are considered clinically significant by the investigator;
- Participated in other drug or medical device clinical trials within 3 months before screening;
- Patients who have received intravenous anti-infective treatment or active infection within 14 days before administration;
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 |
|---|---|---|
| WTX221Also: cyclophosphamideDrug: WTX221 WTX221 infusion once every 30 days for two doses in total Drug: CTX Co-administration of CTX and WTX221 at the initial infusion | Drug | Treatment group A, Treatment group B, Treatment group C |
Primary outcome
To evaluate the safety and tolerability of multiple doses of WTX221 infusion combined with a single dose of cyclophosphamide in patients with refractory gout.
Time frame: from the first WTX221 infusion to 210 days
Adverse Events and Serious Adverse Events
4 secondary outcomes
To evaluate the pharmacokinetic (PK) profile of multiple doses of WTX221 infusion combined with a single dose of cyclophosphamide in patients with refractory gout;
Time frame: from the first WTX221 infusion to 210 days
To evaluate the pharmacodynamic (PD) profile of multiple doses of WTX221 infusion combined with a single dose of cyclophosphamide in patients with refractory gout
Time frame: from the first WTX221 infusion to 210 days
To evaluate the preliminary efficacy of multiple doses of WTX221 infusion combined with a single dose of cyclophosphamide in patients with refractory gout
Time frame: from the first WTX221 infusion to 60days Number of gout flares in subjects (within 60 days);
To evaluate immunogenicity (ADA) levels of multiple doses of WTX221 infusion combined with a single dose of cyclophosphamide in patients with refractory gout
Time frame: from the first WTX221 infusion to 210days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing WTX221 in people with Gout Tophus, run by RenJi Hospital.
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 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: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Ting Lee, phD (021-68383204, leeting007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of multiple doses of WTX221 infusion combined with a single dose of cyclophosphamide in patients with refractory gout. (time frame: from the first WTX221 infusion to 210 days). 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 5 Apr 2023.