Polycythemia VeraPhase 2/3PreVailNCT07859423
A Study to Investigate AG-236 in Subjects ≥18 Years of Age With Polycythemia Vera
A Phase 2/3 study testing AG-236 in people with Polycythemia Vera, run by Agios Pharmaceuticals, Inc..
Trial summary
This clinical trial is a Phase 2/3 study that will determine the recommended dose and dose regimen of AG-236 and evaluate the efficacy, safety, and pharmacokinetics of AG-236 in polycythemia vera (PV) by testing how well AG-236 works compared to placebo to increase the number of subjects with no phlebotomy and absence… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera
- What is being tested?
- AG-236
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 245 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Aug 2032
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PV diagnosis according to 2022 World Health Organization (WHO) criteria.
- Phlebotomy requirements:
- At least 3 documented phlebotomies in the 6 months before randomization or at least 5 documented phlebotomies in the 12 months before randomization; and
- At least 1 documented phlebotomy within the 3 months before randomization.
- No phlebotomy within 6 days before randomization (not including the day of phlebotomy and the day of randomization in the 6-day count).
- Cytoreductive therapy is allowed at randomization, but the subject must be on a stable regimen for at least 2 months prior (or at least 6 months with interferons) with no planned change in cytoreductive dose.
- Subjects on phlebotomy alone and no cytoreductive therapy at randomization must have stopped prior treatment at least 2 months prior (at least 6 months for interferons).
Who cannot join
- Use of any investigational or marketed N-acetylgalactosamine (GalNAc) targeting product less than 48 weeks before randomization or not recovered from effects of prior administration of any investigational or marketed GalNAc targeting product taken more than 48 weeks before randomization.
- Currently receiving treatment with a hepcidin mimetic; the last dose must have been administered ≥6 months before randomization.
- Currently receiving treatment with or history of any use of TMPRSS6 targeting molecules (antisense oligonucleotide [ASO], siRNA, antibodies) before randomization.
- Clinically significant, active and/or uncontrolled hepatobiliary, renal, cardiac, or pulmonary disease.
- Prior malignancy in the last 5 years, except for curatively treated basal cell carcinoma or non-melanoma skin tumors, curatively treated carcinoma in situ of the cervix or breast, or localized prostate cancer.
- Clinically significant thrombosis within 2 months before randomization.
- Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment.
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2/3, Double-blind, Randomized, Placebo-Controlled, Multicenter, Efficacy, Safety, and Pharmacokinetics Study of AG-236 in Subjects With Polycythemia Vera
This clinical trial is a Phase 2/3 study that will determine the recommended dose and dose regimen of AG-236 and evaluate the efficacy, safety, and pharmacokinetics of AG-236 in polycythemia vera (PV) by testing how well AG-236 works compared to placebo to increase the number of subjects with no phlebotomy and absence of phlebotomy eligibility over a 13-week period. In addition, the long-term effect of AG-236 on efficacy and safety will be explored in an open-label extension portion.
Read the detailed description
AG-236 is a small interfering ribonucleic acid (siRNA) targeting transmembrane serine protease 6 (TMPRSS6) intended for the treatment of PV. The study aims to evaluate the efficacy and safety of treatment with AG-236 in subjects with PV. The study is a Phase 2/3 study in which the recommended dose and dose regimen of AG-236 will be selected and further evaluated. The Phase 2 portion includes a 26-week randomized, placebo-controlled period in which subjects will be randomized in a 1:1:1:1:1 ratio to receive 1 of 3 dose levels of AG-236 in 1 of 2 dose regimens or placebo. The Phase 3 portion includes a 26-week randomized, placebo-controlled period in which subjects will be randomized in a 2:1 ratio to receive the recommended AG-236 dose level and dose regimen or placebo. Subjects who complete either the Phase 2 or Phase 3 portion will have the option to move into a 104-week open-label extension period to receive AG-236.
- Conditions
- Polycythemia Vera
- Being tested
- AG-236, Placebo
- Medical subject headings
- Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG-236Drug
SC Injection
PlaceboDrug
SC Injection
| Study group | Role | What they receive |
|---|---|---|
| Phase 2: AG-236 Dose X | Experimental | Subjects will receive AG-236 Dose X, administered subcutaneously (SC), according to the assigned dosing regimen, along with placebo administered SC as needed to maintain the blind in the double-blind period and will receive the same assigned AG-236 dose according to the protocol-defined regimen if they opt to participate in the extension period. Receives: Drug: AG-236; Drug: Placebo |
| Phase 2: AG-236 Dose Y | Experimental | Subjects will receive AG-236 Dose Y, administered SC, according to the assigned dosing regimen, along with placebo administered SC as needed to maintain the blind in the double-blind period and will receive the same assigned AG-236 dose according to the protocol-defined regimen if they opt to participate in the extension period. Receives: Drug: AG-236; Drug: Placebo |
| Phase 2: AG-236 Dose Z | Experimental | Subjects will receive AG-236 Dose Z, administered SC, according to the assigned dosing regimen, along with placebo administered SC as needed to maintain the blind in the double-blind period and will receive the same assigned AG-236 dose according to the protocol-defined regimen if they opt to participate in the extension period. Receives: Drug: AG-236; Drug: Placebo |
| Phase 2: AG-236 Dose ZZ | Experimental | Subjects will receive AG-236 Dose ZZ, administered SC, according to the assigned dosing regimen in the double-blind period, and will receive the same assigned AG-236 dose according to the protocol-defined regimen if they opt to participate in the extension period. Receives: Drug: AG-236 |
| Phase 2: Placebo | Placebo comparator | Subjects will receive placebo administered SC, according to the assigned dosing regimen in the double-blind period and will be randomized to receive AG-236 Dose X, Y, or Z if they opt to participate in the extension period. Receives: Drug: Placebo |
| Phase 3: AG-236 | Experimental | Subjects will receive AG-236, administered SC at the dose and dose regimen selected for Phase 3 for 26 weeks in the double-blind period. Subjects who complete the double-blind period of the study will be eligible to continue receiving AG-236 in the open-label extension period. Receives: Drug: AG-236 |
| Phase 3: Placebo | Placebo comparator | Subjects will receive placebo administered SC at the dose and dose regimen selected for Phase 3 for 26 weeks in the double-blind period. Subjects who complete the double-blind period of the study will be eligible to continue receiving AG-236 in the open-label extension period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 2 and Phase 3: Percentage of Subjects With No Phlebotomy and Absence of Phlebotomy Eligibility
Measured: Week 13 Through Week 26
Secondary outcomes (21)
Phase 2 and Phase 3: Number of Phlebotomies During the Double-blind Period
Measured: Up to Week 26
Phase 2: Percentage of Subjects Achieving Hematocrit (HCT) Response During the Double-blind Period
HCT response is defined as having at most one HCT assessment ≥45 percent (%) during the double-blind period.
Measured: Up to Week 26
Phase 2 and Phase 3: Time to First HCT ≥45%
Measured: Up to Week 26
Phase 2 and Phase 3: Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to Week 130
Phase 2 and Phase 3: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of AG-236
Measured: Each dose occasion from Day 1 to Week 52
Phase 2 and Phase 3: Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of AG-236
Measured: Each dose occasion from Day 1 to Week 52
Phase 2 and Phase 3: Maximum Observed Plasma Concentration (Cmax) of AG-236
Measured: Each dose occasion from Day 1 to Week 52
Phase 2 and Phase 3: Percentage of Area Under the Concentration-Time Curve due to Extrapolation From the Last Quantifiable Concentration to Infinity (AUC%extrap) of AG-236
Measured: Each dose occasion from Day 1 to Week 52
Phase 2 and Phase 3: Time to Last Measurable Concentration (tlast) of AG-236
Measured: Each dose occasion from Day 1 to Week 52
Phase 2 and Phase 3: Time to Reach Maximum Observed Plasma Concentration (tmax) of AG-236
Measured: Each dose occasion from Day 1 to Week 52
Phase 2 and Phase 3: Terminal Elimination Half-Life (t1/2) of AG-236
Measured: Each dose occasion from Day 1 to Week 52
Phase 2 and Phase 3: Apparent Total Body Clearance (CL/F) of AG-236
Measured: Each dose occasion from Day 1 to Week 52
Phase 2 and Phase 3: Apparent Volume of Distribution (Vz/F) of AG-236
Measured: Each dose occasion from Day 1 to Week 52
Phase 3: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 8a T-score at Week 26
Measured: Baseline, Week 26
Phase 3: Change From Baseline in PROMIS Fatigue SF 8a T-score at Week 26 Among Those who Have Fatigue at Baseline
Measured: Baseline, Week 26
Phase 3: Percentage of Subjects With Improvement in the Patient Global Impression of Severity (PGIS) -Fatigue by at Least one Category at Week 26 Compared with Baseline or "No Change" if None or Mild Fatigue at Baseline
Measured: Baseline, Week 26
Phase 3: Percentage of Subjects With Improvement in the Patient Global Impression of Change (PGIC) -Fatigue at Week 26 or "No Change" if None or Mild Fatigue at Baseline
Measured: Baseline, Week 26
Phase 3: Change From Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 Total Symptom Score at Week 26
Measured: Baseline, Week 26
Phase 3: Change From Baseline in MFSAF v4.0 Total Symptom Score at Week 26 Among Those who Have Symptoms at Baseline
Measured: Baseline, Week 26
Phase 3: Percentage of Subjects With Improvement in the PGIS-PV Symptoms by at Least 1 Category at Week 26 Compared With Baseline or "No Change" if None or Mild PV Symptoms at Baseline
Measured: Baseline, Week 26
Phase 3: Percentage of Subjects With Improvement in the PGIC-PV Symptoms at Week 26 or "No Change" if None or Mild PV Symptoms at Baseline
Measured: Baseline, Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia VeraStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agios Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859423
- Sponsor's protocol ID
- AG236-C-002
- Other IDs
- 2026-527243-18-00
- Acronym
- PreVail
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 13 Oct 2026
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Double-blind, Randomized, Placebo-Controlled, Multicenter, Efficacy, Safety, and Pharmacokinetics Study of AG-236 in Subjects With Polycythemia Vera
- ClinicalTrials.gov ID
- NCT07859423
- Acronym / sponsor ID
- PreVail / AG236-C-002
- Conditions
- Polycythemia Vera
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- Agios Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2032 (estimated)
- First posted
- 5 Oct 2026 (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 clinical trial is a Phase 2/3 study that will determine the recommended dose and dose regimen of AG-236 and evaluate the efficacy, safety, and pharmacokinetics of AG-236 in polycythemia vera (PV) by testing how well AG-236 works compared to placebo to increase the number of subjects with no phlebotomy and absence of phlebotomy eligibility over a 13-week period. In addition, the long-term effect of AG-236 on efficacy and safety will be explored in an open-label extension portion.
Detailed description
AG-236 is a small interfering ribonucleic acid (siRNA) targeting transmembrane serine protease 6 (TMPRSS6) intended for the treatment of PV. The study aims to evaluate the efficacy and safety of treatment with AG-236 in subjects with PV. The study is a Phase 2/3 study in which the recommended dose and dose regimen of AG-236 will be selected and further evaluated. The Phase 2 portion includes a 26-week randomized, placebo-controlled period in which subjects will be randomized in a 1:1:1:1:1 ratio to receive 1 of 3 dose levels of AG-236 in 1 of 2 dose regimens or placebo. The Phase 3 portion includes a 26-week randomized, placebo-controlled period in which subjects will be randomized in a 2:1 ratio to receive the recommended AG-236 dose level and dose regimen or placebo. Subjects who complete either the Phase 2 or Phase 3 portion will have the option to move into a 104-week open-label extension period to receive AG-236.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Phase 2: AG-236 Dose X | Experimental | Drug: AG-236, Drug: PlaceboSubjects will receive AG-236 Dose X, administered subcutaneously (SC), according to the assigned dosing regimen, along with placebo administered SC as needed to maintain the blind in the double-blind period and will receive the same assigned AG-236 dose according to the protocol-defined regimen if they opt to participate in the extension period. |
| Phase 2: AG-236 Dose Y | Experimental | Drug: AG-236, Drug: PlaceboSubjects will receive AG-236 Dose Y, administered SC, according to the assigned dosing regimen, along with placebo administered SC as needed to maintain the blind in the double-blind period and will receive the same assigned AG-236 dose according to the protocol-defined regimen if they opt to participate in the extension period. |
| Phase 2: AG-236 Dose Z | Experimental | Drug: AG-236, Drug: PlaceboSubjects will receive AG-236 Dose Z, administered SC, according to the assigned dosing regimen, along with placebo administered SC as needed to maintain the blind in the double-blind period and will receive the same assigned AG-236 dose according to the protocol-defined regimen if they opt to participate in the extension period. |
| Phase 2: AG-236 Dose ZZ | Experimental | Drug: AG-236Subjects will receive AG-236 Dose ZZ, administered SC, according to the assigned dosing regimen in the double-blind period, and will receive the same assigned AG-236 dose according to the protocol-defined regimen if they opt to participate in the extension period. |
| Phase 2: Placebo | Placebo comparator | Drug: PlaceboSubjects will receive placebo administered SC, according to the assigned dosing regimen in the double-blind period and will be randomized to receive AG-236 Dose X, Y, or Z if they opt to participate in the extension period. |
| Phase 3: AG-236 | Experimental | Drug: AG-236Subjects will receive AG-236, administered SC at the dose and dose regimen selected for Phase 3 for 26 weeks in the double-blind period. Subjects who complete the double-blind period of the study will be eligible to continue receiving AG-236 in the open-label extension period. |
| Phase 3: Placebo | Placebo comparator | Drug: PlaceboSubjects will receive placebo administered SC at the dose and dose regimen selected for Phase 3 for 26 weeks in the double-blind period. Subjects who complete the double-blind period of the study will be eligible to continue receiving AG-236 in the open-label extension period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- PV diagnosis according to 2022 World Health Organization (WHO) criteria.
- Phlebotomy requirements:
- Cytoreductive therapy is allowed at randomization, but the subject must be on a stable regimen for at least 2 months prior (or at least 6 months with interferons) with no planned change in cytoreductive dose.
- Subjects on phlebotomy alone and no cytoreductive therapy at randomization must have stopped prior treatment at least 2 months prior (at least 6 months for interferons).
Key exclusion criteria (8 listed)
- Use of any investigational or marketed N-acetylgalactosamine (GalNAc) targeting product less than 48 weeks before randomization or not recovered from effects of prior administration of any investigational or marketed GalNAc targeting product taken more than 48 weeks before randomization.
- Currently receiving treatment with a hepcidin mimetic; the last dose must have been administered ≥6 months before randomization.
- Currently receiving treatment with or history of any use of TMPRSS6 targeting molecules (antisense oligonucleotide [ASO], siRNA, antibodies) before randomization.
- Clinically significant, active and/or uncontrolled hepatobiliary, renal, cardiac, or pulmonary disease.
- Prior malignancy in the last 5 years, except for curatively treated basal cell carcinoma or non-melanoma skin tumors, curatively treated carcinoma in situ of the cervix or breast, or localized prostate 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 |
|---|---|---|
| AG-236SC Injection | Drug | Phase 2: AG-236 Dose X, Phase 2: AG-236 Dose Y, Phase 2: AG-236 Dose Z, Phase 2: AG-236 Dose ZZ, Phase 3: AG-236 |
| PlaceboSC Injection | Drug | Phase 2: AG-236 Dose X, Phase 2: AG-236 Dose Y, Phase 2: AG-236 Dose Z, Phase 2: Placebo, Phase 3: Placebo |
Primary outcome
Phase 2 and Phase 3: Percentage of Subjects With No Phlebotomy and Absence of Phlebotomy Eligibility
Time frame: Week 13 Through Week 26
21 secondary outcomes
Phase 2 and Phase 3: Number of Phlebotomies During the Double-blind Period
Time frame: Up to Week 26
Phase 2: Percentage of Subjects Achieving Hematocrit (HCT) Response During the Double-blind Period
Time frame: Up to Week 26
Phase 2 and Phase 3: Time to First HCT ≥45%
Time frame: Up to Week 26
Phase 2 and Phase 3: Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week 130
Phase 2 and Phase 3: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of AG-236
Time frame: Each dose occasion from Day 1 to Week 52
Phase 2 and Phase 3: Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of AG-236
Time frame: Each dose occasion from Day 1 to Week 52
Phase 2 and Phase 3: Maximum Observed Plasma Concentration (Cmax) of AG-236
Time frame: Each dose occasion from Day 1 to Week 52
Phase 2 and Phase 3: Percentage of Area Under the Concentration-Time Curve due to Extrapolation From the Last Quantifiable Concentration to Infinity (AUC%extrap) of AG-236
Time frame: Each dose occasion from Day 1 to Week 52
Phase 2 and Phase 3: Time to Last Measurable Concentration (tlast) of AG-236
Time frame: Each dose occasion from Day 1 to Week 52
Phase 2 and Phase 3: Time to Reach Maximum Observed Plasma Concentration (tmax) of AG-236
Time frame: Each dose occasion from Day 1 to Week 52
Phase 2 and Phase 3: Terminal Elimination Half-Life (t1/2) of AG-236
Time frame: Each dose occasion from Day 1 to Week 52
Phase 2 and Phase 3: Apparent Total Body Clearance (CL/F) of AG-236
Time frame: Each dose occasion from Day 1 to Week 52
Phase 2 and Phase 3: Apparent Volume of Distribution (Vz/F) of AG-236
Time frame: Each dose occasion from Day 1 to Week 52
Phase 3: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 8a T-score at Week 26
Time frame: Baseline, Week 26
Phase 3: Change From Baseline in PROMIS Fatigue SF 8a T-score at Week 26 Among Those who Have Fatigue at Baseline
Time frame: Baseline, Week 26
Phase 3: Percentage of Subjects With Improvement in the Patient Global Impression of Severity (PGIS) -Fatigue by at Least one Category at Week 26 Compared with Baseline or "No Change" if None or Mild Fatigue at Baseline
Time frame: Baseline, Week 26
Phase 3: Percentage of Subjects With Improvement in the Patient Global Impression of Change (PGIC) -Fatigue at Week 26 or "No Change" if None or Mild Fatigue at Baseline
Time frame: Baseline, Week 26
Phase 3: Change From Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 Total Symptom Score at Week 26
Time frame: Baseline, Week 26
Phase 3: Change From Baseline in MFSAF v4.0 Total Symptom Score at Week 26 Among Those who Have Symptoms at Baseline
Time frame: Baseline, Week 26
Phase 3: Percentage of Subjects With Improvement in the PGIS-PV Symptoms by at Least 1 Category at Week 26 Compared With Baseline or "No Change" if None or Mild PV Symptoms at Baseline
Time frame: Baseline, Week 26
Phase 3: Percentage of Subjects With Improvement in the PGIC-PV Symptoms at Week 26 or "No Change" if None or Mild PV Symptoms at Baseline
Time frame: Baseline, Week 26
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 13 Oct 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AG-236 in people with Polycythemia Vera, run by Agios Pharmaceuticals, Inc..
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 7 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: opening soon, as of the sponsor's last update on 13 Oct 2026. 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. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Agios Medical Affairs (08332288474, medinfo@agios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 2 and Phase 3: Percentage of Subjects With No Phlebotomy and Absence of Phlebotomy Eligibility (time frame: Week 13 Through Week 26). 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 13 Oct 2026.