Prostate CancerPhase 3KATANA E6MNCT06795191
Efficacy, Safety, and Pharmacokinetics of FP-014, 22.5 mg in Patients With Advanced Prostate Cancer
A Phase 3 study testing Triptorelin Mesylate in people with Prostate Cancer, run by Foresee Pharmaceuticals Co., Ltd..
Trial summary
This is a study in male patients with advanced prostate cancer who are eligible for androgen ablation therapy. The study duration will be up to 48 weeks. Eligibility will be assessed during a screening period of up to 28 days. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Triptorelin Mesylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 2 Jan 2028
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males aged ≥ 18 years old at Screening.
- Histologically confirmed carcinoma of the prostate at the time of Screening.
- Metastatic or biochemically recurrent prostate cancer disease at Screening.
- Patient agrees to use male contraceptive methods during the study.
- In the Investigator's opinion, the patient understands the nature of the study and any hazards of participation, communicates satisfactorily with the Investigator, and is able to participate in and comply with the requirements of the entire protocol.
- Patients judged by the attending physician and/or Principal Investigator to be a candidate for androgen ablation therapy.
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- Patients who are able to tolerate ablation therapy but are considered unable to tolerate androgen receptor pathway inhibitors.
- ECOG Performance Status score ≤ 2 and life expectancy of at least 18 months at Screening.
- Baseline morning serum testosterone level > 150 ng/dL at Screening.
- Laboratory values at Screening:
- Absolute neutrophil count ≥ 1,500 cells/μL;
- Platelets ≥ 100,000 cells/μL;
- Hemoglobin ≥ 10 gm/dL;
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN);
- AST ≤ 2.5 × ULN;
- ALT ≤ 2.5 × ULN;
- Creatinine Clearance ≥ 30 mL/min or estimated Glomerular Filtration Rate (eGFR) > 30 mL/min/1.73°m2 or evidence of acute kidney injury;
- Lipid profile within the acceptable range according to the Investigator's opinion;
- Serum glucose within the acceptable range according to the Investigator's opinion;
- HbA1c within the acceptable range according to the Investigator's opinion;
- Clinical chemistries (K, Na, Mg, Ca, and P) within the acceptable range according to the Investigator's opinion;
- Normal urinalysis results:
- red blood cells (RBCs) ≤ 3 RBCs/hpf;
- white blood cells (WBCs) ≤ 5 WBCs/hpf;
- nitrate: negative;
- glucose: <0.1 g/dL in patients without diabetes mellitus Type II and < 1.0 g/dL in patients with diabetes mellitus Type II.
Who cannot join
- Receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti- androgen therapy within 8 weeks prior to Screening, for treatment of carcinoma of the prostate.
- Receipt of any luteinizing hormone-releasing hormone (LH-RH) suppressive therapy within 6 months of the Screening Visit.
- Receipt of any vaccination (including influenza) within 2 weeks of the Screening Visit.
- History of blood donation within 2 months of the Screening Visit.
- History of anaphylaxis to any LH-RH analogues.
- Contraindication to triptorelin or an LH-RH agonist as indicated on the package labeling.
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- Previous exposure to triptorelin mesylate.
- Major surgery, including any prostatic surgery (excluding prostatic biopsy), within 4 weeks of the Screening Visit.
- History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.
- History of clinical and radiographic evidence of central nervous system dysfunction.
- Spinal cord metastases and patients at risk for spinal cord compression.
- Clinical evidence of uncontrolled active urinary tract obstruction and patients at risk for urinary obstruction.
- Clinically significant abnormal ECG at Screening and/or history of clinically significant ECG.
- Cardiovascular disease that is clinically significant as judged by the Investigator.
- History of Uncontrolled diabetes, HbA1C >9.5%, urine glycosuria >1.0 g/dl, or presence of diabetic ketoacidosis.
- History of liver dysfunction, including patients with moderate (Child-Pugh B) or severe (Child-Pugh C) impairment or disordered coagulation.
- End-stage renal diseases on peritoneal dialysis or hemodialysis.
- History or presence of hypogonadism; or receipt of exogenous testosterone supplementation within 6 months of Screening Visit.
- Use of systemic corticosteroids at a dose > 10 mg/day at Screening.
- Use of 5-alpha reductase inhibitor within the last 6 months of Screening Visit.
- Use of any over-the-counter (OTC) medication within 4 weeks of the Screening Visit, except for those listed as permitted concomitant treatment.
- History of drug and/or alcohol abuse within 6 months of Screening Visit.
- Use of any investigational agent within 4 weeks of the Screening Visit.
- Use of any therapeutics with strong inhibitors and strong inducers of CYP3A4 or CYP2C8 [e.g., rifampicin, ketoconazole, phenytoin, ritonavir, macrolide antibiotics (e.g. telithromycin)] at the time of Screening.
About this study
Official title: A Global, Phase 3, Open-Label, Single Arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of FP-014, 22.5 mg (Triptorelin Mesylate Injection, 22.5 mg) in Patients With Advanced Prostate Cancer (KATANA E6M)
This is a study in male patients with advanced prostate cancer who are eligible for androgen ablation therapy. The study duration will be up to 48 weeks.
Eligibility will be assessed during a screening period of up to 28 days. Up to 2 doses of a long-acting FP-014, 22.5 mg formulation will be given to the patients by separate SC injections 24 weeks apart in an unblinded manner. The first dose of FP-014, 22.5 mg will be administered on Day 0 (Visit 2/Week 1). When patients have tolerated the first dose of FP-014, 22.5 mg and have achieved castrate levels of serum testosterone, a second dose will be administered on Day 168 (Visit 14/Week 24) to achieve castrate levels of serum testosterone concentrations (< 50 ng/dL). Patients will be followed for efficacy, safety, tolerability, and ancillary clinical and laboratory markers for an additional 24-week observation period (Day 336/Week 48/ Visit 24) Blood samples will be collected at Baseline (Day 0/Week 1) at least 30 minutes before the first FP-014, 22.5 mg administration, immediately thereafter and at specified time points through Day 336 (Week 48) to determine PK (triptorelin) and pharmacodynamics (PD) (testosterone, PSA, and LH) profiles.
Read the detailed description
This is a study in male patients with advanced prostate cancer who are eligible for androgen ablation therapy. The study duration will be up to 48 weeks.
Eligibility will be assessed during a screening period of up to 28 days. Up to 2 doses of a long-acting FP-014, 22.5 mg formulation will be given to the patients by separate SC injections 24 weeks apart in an unblinded manner. The first dose of FP-014, 22.5 mg will be administered on Day 0 (Visit 2/Week 1). When patients have tolerated the first dose of FP-014, 22.5 mg and have achieved castrate levels of serum testosterone, a second dose will be administered on Day 168 (Visit 14/Week 24) to achieve castrate levels of serum testosterone concentrations (< 50 ng/dL). Patients will be followed for efficacy, safety, tolerability, and ancillary clinical and laboratory markers for an additional 24-week observation period (Day 336/Week 48/ Visit 24) Blood samples will be collected at Baseline (Day 0/Week 1) at least 30 minutes before the first FP-014, 22.5 mg administration, immediately thereafter and at specified time points through Day 336 (Week 48) to determine PK (triptorelin) and pharmacodynamics (PD) (testosterone, PSA, and LH) profiles.
To evaluate the sustained castration testosterone level after two administrations of FP-014, 22.5 mg, the first 30 enrolled patients will be considered as a subset for PK assessments. For these 30 subjects, additional PK/PD analyses will be performed on dosing days to obtain an extended PK/PD profile of serum triptorelin and testosterone levels.
The efficacy assessments will be performed in both intent-to-treat (ITT) and per-protocol (PP) populations. Efficacy assessment will include the percentage of patients who reached the castrate levels (< 50 ng/dL) of serum testosterone on Day 28 (± 2 days; Week 4) post the first dosing of FP-014, 22.5 mg. Furthermore, the effect of FP-014, 22.5 mg on serum levels of PSA, and LH will be assessed post the first and the second dosing of FP-014, 22.5 mg, respectively. Urinary tract signs and symptoms will be evaluated for efficacy using the International Prostate Symptom Score [I-PSS] and recorded in the electronic case report forms (eCRFs). The acute-on-chronic (surge) effect of serum testosterone and LH levels will also be monitored in all patients. In addition, the impact of FP-014, 22.5 mg, on the percentage (rate) of patients with PSA relapse, on the percentage of patients that achieves normal serum PSA level, and on the percentage of patients with an enhanced serum testosterone concentration suppression (< 20 ng/dL) will be determined at the end of study.
All treatment emergent adverse events (TEAEs), including adverse events of interest (AEoI), that occur during the study period and serious adverse events (SAEs) that occur during the study period will be recorded in the eCRFs and followed until they are resolved or considered stable. In addition, all SAEs will be recorded and reported as required by local and international regulatory requirements.
Other safety assessments and their results including safety clinical laboratory parameters, vital signs, physical examination, resting 12-lead electrocardiogram (ECG), injection site reactions and bone pain (assessed using visual analog scale [VAS]) will also be recorded in the eCRF.
Patients who discontinue early should be encouraged to remain in the study for safety evaluations.
A Data Safety Monitoring Board (DSMB) composed of independent experts will review available safety results every 3 months, and on an ad hoc basis if deemed necessary, from the moment onwards when one month data is available from approximately 5% of enrolled patients until the last patient completes the study. The composition and responsibilities of the DSMB will be defined in a separate DSMB charter.
- Conditions
- Prostate Cancer
- Being tested
- Triptorelin Mesylate
- Keywords
- Prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorelin MesylateDrug
22.5 mg in a prefilled, ready-to-use, long-acting formulation
| Study group | Role | What they receive |
|---|---|---|
| FP-014 | Experimental | Each patient will receive 2 single doses of FP-014, 22.5 mg administered as SC injections. The two injections of the study drug will be administered 24 weeks apart; one injection at Baseline (Visit 2/Day 0/Week 1), and one at Visit 14 (Day 168/Week 24) to achieve castrate serum testosterone level (< 50 ng/dL). Receives: Drug: Triptorelin Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoints
The percentage of patients with a serum testosterone concentration suppressed to castrate levels (< 50 ng/dL).
Measured: Baseline to Week 4 (Day 28 ± 1 day) following the first SC injection of FP-014 (22.5 mg).
Primary Endpoints
The percentage of patients with serum testosterone concentration suppressed to castrate levels (< 50 ng/dL)
Measured: from Week 4 (Day 28 ± 1 day) through Week 48 (Day 336 ± 5 days).
Secondary outcomes (7)
Secondary Endpoints
The mean acute-on-chronic (surge) changes in serum testosterone and LH levels prior to the second injection.
Measured: From injection through 48-72 hours after the second injection of FP-014, 22.5 mg
Secondary Endpoints
The mean change of serum LH levels.
Measured: Baseline to Week 48/End of Study (EOS) (Day 336 ± 5 days).
Secondary Endpoints
The mean change of serum PSA levels.
Measured: Baseline to Week 48/EOS (Day 336 ± 5 days)
Secondary Endpoints
The percentage of patients with:
PSA relapse (defined as an increase in serum PSA of > 50% PSA nadir after achieving serum PSA level ≤ 4 ng/mL post administration of FP-014, 22.5 mg.
Measured: Week 48/EOS (Day 336 ± 5 days)
Secondary Endpoints
The percentage of patients with:
Within normal limit serum PSA level (≤ 4 ng/mL)
Measured: Week 48/EOS (Day 336 ± 5 days)
Secondary Endpoints
The percentage of patients with enhanced serum testosterone concentration suppression to < 20 ng/dL.
Measured: Week 4 (Day 28 ± 1 day) and at Week 48/EOS (Day 336 ± 5 days.
Secondary Endpoints
Urinary signs and symptoms, i.e. a patient-reported outcome (PRO) assessed by the total score of the International Prostate Symptom Score (I-PSS) (Range 0-35 with 35 being the worst symptoms)
Measured: Baseline to Week 48/EOS (Day 336 ± 5 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion2 Jan 2028 (estimated)
Why it stopped: Business reasons not safety related.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foresee Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QPS Holdings LLC
- Responsible party
- Sponsor
- Investigators
- Susan Whitaker, BSN, MS, MBA, Study director, Foresee Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795191
- Sponsor's protocol ID
- FP014C-24-002
- Acronym
- KATANA E6M
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global, Phase 3, Open-Label, Single Arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of FP-014, 22.5 mg (Triptorelin Mesylate Injection, 22.5 mg) in Patients With Advanced Prostate Cancer (KATANA E6M)
- ClinicalTrials.gov ID
- NCT06795191
- Acronym / sponsor ID
- KATANA E6M / FP014C-24-002
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business reasons not safety related.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Foresee Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- QPS Holdings LLC
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 2 Jan 2028 (estimated)
- First posted
- 27 Jan 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.
This is a study in male patients with advanced prostate cancer who are eligible for androgen ablation therapy. The study duration will be up to 48 weeks.
Eligibility will be assessed during a screening period of up to 28 days. Up to 2 doses of a long-acting FP-014, 22.5 mg formulation will be given to the patients by separate SC injections 24 weeks apart in an unblinded manner. The first dose of FP-014, 22.5 mg will be administered on Day 0 (Visit 2/Week 1). When patients have tolerated the first dose of FP-014, 22.5 mg and have achieved castrate levels of serum testosterone, a second dose will be administered on Day 168 (Visit 14/Week 24) to achieve castrate levels of serum testosterone concentrations (< 50 ng/dL). Patients will be followed for efficacy, safety, tolerability, and ancillary clinical and laboratory markers for an additional 24-week observation period (Day 336/Week 48/ Visit 24) Blood samples will be collected at Baseline (Day 0/Week 1) at least 30 minutes before the first FP-014, 22.5 mg administration, immediately thereafter and at specified time points through Day 336 (Week 48) to determine PK (triptorelin) and pharmacodynamics (PD) (testosterone, PSA, and LH) profiles.
Detailed description
This is a study in male patients with advanced prostate cancer who are eligible for androgen ablation therapy. The study duration will be up to 48 weeks.
Eligibility will be assessed during a screening period of up to 28 days. Up to 2 doses of a long-acting FP-014, 22.5 mg formulation will be given to the patients by separate SC injections 24 weeks apart in an unblinded manner. The first dose of FP-014, 22.5 mg will be administered on Day 0 (Visit 2/Week 1). When patients have tolerated the first dose of FP-014, 22.5 mg and have achieved castrate levels of serum testosterone, a second dose will be administered on Day 168 (Visit 14/Week 24) to achieve castrate levels of serum testosterone concentrations (< 50 ng/dL). Patients will be followed for efficacy, safety, tolerability, and ancillary clinical and laboratory markers for an additional 24-week observation period (Day 336/Week 48/ Visit 24) Blood samples will be collected at Baseline (Day 0/Week 1) at least 30 minutes before the first FP-014, 22.5 mg administration, immediately thereafter and at specified time points through Day 336 (Week 48) to determine PK (triptorelin) and pharmacodynamics (PD) (testosterone, PSA, and LH) profiles.
To evaluate the sustained castration testosterone level after two administrations of FP-014, 22.5 mg, the first 30 enrolled patients will be considered as a subset for PK assessments. For these 30 subjects, additional PK/PD analyses will be performed on dosing days to obtain an extended PK/PD profile of serum triptorelin and testosterone levels.
The efficacy assessments will be performed in both intent-to-treat (ITT) and per-protocol (PP) populations. Efficacy assessment will include the percentage of patients who reached the castrate levels (< 50 ng/dL) of serum testosterone on Day 28 (± 2 days; Week 4) post the first dosing of FP-014, 22.5 mg. Furthermore, the effect of FP-014, 22.5 mg on serum levels of PSA, and LH will be assessed post the first and the second dosing of FP-014, 22.5 mg, respectively. Urinary tract signs and symptoms will be evaluated for efficacy using the International Prostate Symptom Score [I-PSS] and recorded in the electronic case report forms (eCRFs). The acute-on-chronic (surge) effect of serum testosterone and LH levels will also be monitored in all patients. In addition, the impact of FP-014, 22.5 mg, on the percentage (rate) of patients with PSA relapse, on the percentage of patients that achieves normal serum PSA level, and on the percentage of patients with an enhanced serum testosterone concentration suppression (< 20 ng/dL) will be determined at the end of study.
All treatment emergent adverse events (TEAEs), including adverse events of interest (AEoI), that occur during the study period and serious adverse events (SAEs) that occur during the study period will be recorded in the eCRFs and followed until they are resolved or considered stable. In addition, all SAEs will be recorded and reported as required by local and international regulatory requirements.
Other safety assessments and their results including safety clinical laboratory parameters, vital signs, physical examination, resting 12-lead electrocardiogram (ECG), injection site reactions and bone pain (assessed using visual analog scale [VAS]) will also be recorded in the eCRF.
Patients who discontinue early should be encouraged to remain in the study for safety evaluations.
A Data Safety Monitoring Board (DSMB) composed of independent experts will review available safety results every 3 months, and on an ad hoc basis if deemed necessary, from the moment onwards when one month data is available from approximately 5% of enrolled patients until the last patient completes the study. The composition and responsibilities of the DSMB will be defined in a separate DSMB charter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FP-014 | Experimental | Drug: Triptorelin MesylateEach patient will receive 2 single doses of FP-014, 22.5 mg administered as SC injections. The two injections of the study drug will be administered 24 weeks apart; one injection at Baseline (Visit 2/Day 0/Week 1), and one at Visit 14 (Day 168/Week 24) to achieve castrate serum testosterone level (< 50 ng/dL). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Males aged ≥ 18 years old at Screening.
- Histologically confirmed carcinoma of the prostate at the time of Screening.
- Metastatic or biochemically recurrent prostate cancer disease at Screening.
- Patient agrees to use male contraceptive methods during the study.
- In the Investigator's opinion, the patient understands the nature of the study and any hazards of participation, communicates satisfactorily with the Investigator, and is able to participate in and comply with the requirements of the entire protocol.
Key exclusion criteria (24 listed)
- Receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti- androgen therapy within 8 weeks prior to Screening, for treatment of carcinoma of the prostate.
- Receipt of any luteinizing hormone-releasing hormone (LH-RH) suppressive therapy within 6 months of the Screening Visit.
- Receipt of any vaccination (including influenza) within 2 weeks of the Screening Visit.
- History of blood donation within 2 months of the Screening Visit.
- History of anaphylaxis to any LH-RH analogues.
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 |
|---|---|---|
| Triptorelin Mesylate22.5 mg in a prefilled, ready-to-use, long-acting formulation | Drug | FP-014 |
Primary outcome
Primary Endpoints
Time frame: Baseline to Week 4 (Day 28 ± 1 day) following the first SC injection of FP-014 (22.5 mg).
The percentage of patients with a serum testosterone concentration suppressed to castrate levels (< 50 ng/dL).
Primary Endpoints
Time frame: from Week 4 (Day 28 ± 1 day) through Week 48 (Day 336 ± 5 days).
The percentage of patients with serum testosterone concentration suppressed to castrate levels (< 50 ng/dL)
7 secondary outcomes
Secondary Endpoints
Time frame: From injection through 48-72 hours after the second injection of FP-014, 22.5 mg
Secondary Endpoints
Time frame: Baseline to Week 48/End of Study (EOS) (Day 336 ± 5 days).
Secondary Endpoints
Time frame: Baseline to Week 48/EOS (Day 336 ± 5 days)
Secondary Endpoints
Time frame: Week 48/EOS (Day 336 ± 5 days)
Secondary Endpoints
Time frame: Week 48/EOS (Day 336 ± 5 days)
Secondary Endpoints
Time frame: Week 4 (Day 28 ± 1 day) and at Week 48/EOS (Day 336 ± 5 days.
Secondary Endpoints
Time frame: Baseline to Week 48/EOS (Day 336 ± 5 days).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- 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.
Susan Whitaker, BSN, MS, MBA study director
Foresee Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triptorelin Mesylate in people with Prostate Cancer, run by Foresee Pharmaceuticals Co., Ltd..
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 26 inclusion and 24 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: withdrawn, as of the sponsor's last update on 27 Apr 2025. 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?
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 was withdrawn before enrolling participants, so there are no results.
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?
Primary Endpoints (time frame: Baseline to Week 4 (Day 28 ± 1 day) following the first SC injection of FP-014 (22.5 mg).). 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?
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 27 Apr 2025.