Immune System DiseasesPhase 2NCT07220811
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
A Phase 2 study testing RPT904 in people with Immune System Diseases and Ig-E Mediated Food Allergy, run by RAPT Therapeutics, Inc., a member of the GSK plc group of companies at 37 sites in 3 countries.
Trial summary
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy: This is a Phase 2b randomized, double-blind, placebo-controlled clinical trial evaluating RPT904, a next-generation anti-IgE monoclonal antibody, in people with food allergy. Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Immune System Diseases, Ig-E Mediated Food Allergy
- What is being tested?
- RPT904
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 37 sitesin 3 countries
- Study dates
- 15 Dec 2025to 21 Dec 2027
- Phase
- Phase 2
- 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 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable.
- Male or female, 12 to less than 56 years of age at screening.
- Allergic to at least 1 of the following foods: peanut, milk, egg, cashew, or walnut, as confirmed by the following criteria:
- a. For participants aged 12 to <18 years:
- i. Allergic to peanut: participant must meet all criteria below:
- 1. Positive SPT (≥4 mm wheal greater than saline control) to peanut.
Show all 41Show fewer
- 2. Positive peanut IgE (≥6 kUA/L) at screening or within 3 months of screening.
- 3. Positive blinded oral food challenge (OFC) to peanut during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg (ie, cumulative dose of ≤144 mg) of peanut protein.
- ii. Allergic to milk or egg: unable to tolerate both cooked and uncooked forms:
- 1. Positive SPT (≥4 mm wheal greater than saline control) to the specific food.
- 2. Positive food-specific IgE (≥6 kUA/L) at screening or within 3 months of screening.
- 3. Positive blinded OFC to the specific food during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg (ie, cumulative dose of ≤444 mg) of food protein.
- iii. Allergic to cashew: participant must meet all criteria below:
- 1. Positive SPT (≥4 mm wheal greater than saline control) to cashew. OR
- 2. Positive cashew IgE (≥6 kUA/L) at screening or within 3 months of screening. AND
- 3. Positive blinded OFC to cashew during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg (ie, cumulative dose of ≤144 mg) of cashew protein.
- iv. Allergic to walnut: participant must meet all criteria below:
- 1. Positive SPT (≥4 mm wheal greater than saline control) to walnut. OR
- 2. Positive walnut IgE (≥6 kUA/L) at screening or within 3 months of screening AND
- 3. Positive blinded OFC to walnut during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg (ie, cumulative dose of ≤444 mg) of walnut protein.
- b. For participants aged 18 to <56 years:
- i. Allergic to peanut or cashew: participant must meet all of the following criteria:
- 1. Positive SPT (≥3 mm wheal greater than saline control) to peanut or cashew.
- 2. Positive peanut or cashew IgE (≥0.35 kUA/L) at screening or within 3 months of screening.
- 3. Positive blinded OFC to peanut or cashew during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg (ie, cumulative dose of ≤144 mg) of peanut or cashew protein.
- ii. Allergic to milk or egg: participant must meet all of the following criteria:
- 1. Positive SPT (≥3 mm wheal greater than saline control) to the specific food.
- 2. Positive food-specific IgE (≥0.35 kUA/L) at screening or within 3 months of screening.
- 3. Positive blinded OFC to the specific food during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg (ie, cumulative dose of ≤444 mg) of food protein.
- iii. Allergic to walnut: participant must meet all of the following criteria:
- 1. Positive SPT (≥3 mm wheal greater than saline control) to walnut.
- 2. Positive walnut IgE (≥0.35 kUA/L) at screening or within 3 months of screening.
- 3. Positive blinded OFC to walnut during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg (ie cumulative dose of ≤444 mg) of walnut protein.
- With body weight (as measured at screening) and total serum IgE level (as measured within 3 months of screening) suitable for RPT904 dosing (per RPT904 dosing table).
- Female Participants:
- 1. Must not be pregnant or breastfeeding.
- 2. Women of non-childbearing potential (e.g., surgically sterile or postmenopausal) are eligible.
- 3. Women of childbearing potential must have a negative pregnancy test before starting study treatment, agree to use a protocol-defined method of contraception during the study and for at least 16 months after the last dose, and must not donate eggs or undergo egg retrieval during this period.
- Male Participants:
- 1. Must agree to either remain abstinent from heterosexual intercourse (if that is their usual lifestyle) or use protocol-defined contraception during the study and for 16 months after the last dose.
- 2. Must not donate semen or participate in sperm banking during this time, and if they have a female partner of childbearing potential, she should also use effective contraception.
Who cannot join
- Clinically significant lab abnormalities at screening.
- Sensitivity or suspected/known allergy to any component of the active or placebo OFC material (excluding the test allergens peanut, milk, egg, walnut, and cashew being tested), or drugs related to RPT904 (eg, monoclonal antibodies, polyclonal gamma globulin).
- Uncontrolled or severe asthma/wheezing at screening.
- Current use of oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers (oral or topical).
- Past or current immunotherapy to any study foods within 6 months of screening.
- Treatment with immunomodulatory therapy within 6 months of screening.
- Currently in the "build-up phase" of inhalant allergen immunotherapy (i.e., not yet on maintenance). Note: individuals on stable maintenance dosing may be eligible.
- Past or current medical problems (eg, severe latex allergy), chronic diseases (other than asthma/wheezing, atopic dermatitis, or rhinitis) requiring therapy (eg, heart disease, diabetes), abnormal physical findings or lab results not listed above that, in the Principal Investigator's opinion, may increase study related risks, hinder protocol compliance, or impact data quality or interpretation .
Trial locations and contacts
37 sites in 3 countries.
37 sites in 3 countries
United States22 sites
GSK Investigational Site
Ann Arbor, Michigan, 48105
GSK Investigational Site
Atlanta, Georgia, 30329
GSK Investigational Site
Aurora, Colorado, 80045
GSK Investigational Site
Austin, Texas, 78723
GSK Investigational Site
Boston, Massachusetts, 02114
GSK Investigational Site
Boston, Massachusetts, 02115
GSK Investigational Site
Chapel Hill, North Carolina, 27599
GSK Investigational Site
Cincinnati, Ohio, 45229
GSK Investigational Site
Colorado Springs, Colorado, 80907-6231
GSK Investigational Site
Denver, Colorado, 80206
GSK Investigational Site
Great Neck, New York, 11021
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Little Rock, Arkansas, 72202
GSK Investigational Site
Minneapolis, Minnesota, 55402-2508
GSK Investigational Site
Nashville, Tennessee, 37212
GSK Investigational Site
New York, New York, 10029
GSK Investigational Site
Palo Alto, California, 94304
GSK Investigational Site
Philadelphia, Pennsylvania, 19104
GSK Investigational Site
Phoenix, Arizona, 85016
GSK Investigational Site
Pittsburgh, Pennsylvania, 15224
GSK Investigational Site
Tampa, Florida, 33613
GSK Investigational Site
Washington D.C., District of Columbia, 20010
Australia9 sites
GSK Investigational Site
Clayton, Victoria, 3168
GSK Investigational Site
Darlinghurst, New South Wales, 2010
GSK Investigational Site
Murdoch, Western Australia, 6150
GSK Investigational Site
Nedlands, Western Australia, 6009
GSK Investigational Site
North Adelaide, South Australia, 5006
GSK Investigational Site
Parkville, Victoria, 3052
GSK Investigational Site
Parkville Melbourne, Victoria, 3050
GSK Investigational Site
South Brisbane, Queensland, 4101
GSK Investigational Site
Westmead, New South Wales, 2145
Canada6 sites
GSK Investigational Site
Burlington, Ontario, L7L 6W6
GSK Investigational Site
Montreal, Quebec, H3T 1C5
GSK Investigational Site
Montreal, Quebec, H4A 0B1
GSK Investigational Site
Ottawa, Ontario, K1H 1E4
GSK Investigational Site
Toronto, Ontario, MSG 1H3
GSK Investigational Site
Vancouver, British Columbia, V6H 3V4
About this study
Official title: Phase 2b Randomized, Double-Blind, Placebo-Controlled Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy: This is a Phase 2b randomized, double-blind, placebo-controlled clinical trial evaluating RPT904, a next-generation anti-IgE monoclonal antibody, in people with food allergy. RPT904 is a long-acting antibody that may allow for dosing every 8 to 12 weeks. Approximately 100 participants between the ages of 12 and 55 with documented allergy to at least one of the following foods: peanut, milk, egg, cashew, or walnut will be enrolled. In Part 1 (24 weeks), participants will be randomly assigned to receive RPT904 every 8 or 12 weeks (plus a loading dose at Week 2), or placebo. In Part 2 (24 weeks), participants who received RPT904 will continue on their assigned dosing schedule, and those who previously received placebo will be re-randomized to receive RPT904 either every 8 or 12 weeks (plus a loading dose at Week 26). All participants will attend study visits approximately every 2-6 weeks throughout both Part 1 and Part 2 to maintain blinding, regardless of treatment group or dosing frequency. The study is being conducted at multiple sites. The primary goal is to assess whether RPT904 helps participants tolerate higher amounts of a food allergen without dose-limiting allergic symptoms during a food challenge. The study will also monitor the safety and side effects of RPT904 over time. Each participant is expected to be in the study for about 68 to 74 weeks, including screening, treatment, and follow-up.
Read the detailed description
Phase 2b Randomized, Double-Blind, Placebo-Controlled Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
- Conditions
- Immune System Diseases, Ig-E Mediated Food Allergy
- Being tested
- RPT904, Placebo
- Keywords
- Ig-E Mediated food allergy, peanut allergy, milk allergy, egg allergy, cashew allergy, walnut allergy, RPT904, placebo, double-blind placebo-controlled food challenge (DBPCFC), ozureprubart, JYB1904
- Medical subject headings
- Immune System Diseases, Peanut Hypersensitivity, Milk Hypersensitivity, Egg Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPT904Drug
Also called ozureprubart, JYB1904
Subcutaneous injection once every 8 weeks
RPT904Drug
Also called ozureprubart, JYB1904
Subcutaneous injection once every 12 weeks
PlaceboOther
Subcutaneous injection at the intervening dosing visits
RPT904Drug
Also called ozureprubart, JYB1904
Subcutaneous injection once every 8 weeks (Part 2)
RPT904Drug
Also called ozureprubart, JYB1904
Subcutaneous injection once every 12 weeks (Part 2)
PlaceboOther
Subcutaneous injection on schedules matching both the Q8W and Q12W arms (Part 1). Subcutaneous injection at the intervening dosing visits (Part 2)
| Study group | Role | What they receive |
|---|---|---|
| RPT904 (Q8W) | Experimental | RPT904 every 8 weeks. The dose levels of RPT904 (150 mg, 300 mg, and 600 mg) within the Q8W cohort will be assigned based on participant weight and baseline total IgE level.
RPT904 subcutaneous injection every 8 weeks with a loading dose at Week 2 (Part 1: 24 weeks; Part 2: 24 weeks); matching placebo at intervening visits to maintain blinding. Receives: Drug: RPT904; Other: Placebo |
| RPT904 (Q12W) | Experimental | RPT904 every 12 weeks. The dose levels of RPT904 (150 mg, 300 mg, and 600 mg) will be assigned based on participant weight and baseline total IgE level.
RPT904 subcutaneous injection every 12 weeks with a loading dose at Week 2 (Part 1: 24 weeks; Part 2: 24 weeks); matching placebo at intervening visits to maintain blinding. Receives: Drug: RPT904; Other: Placebo |
| Placebo | Placebo comparator | Placebo subcutaneous injection on schedules matching both the Q8W and Q12W arms in Part 1 (24 weeks); RPT904 every 8 or 12 weeks with a loading dose at Week 26 on schedules matching both the Q8W and Q12W arms Part 2 (24 weeks), with matching placebo at intervening visits to maintain blinding. Receives: Drug: RPT904; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the ability to consume a food without dose-limiting symptoms during a DBPCFC at the end of Part 1 after treatment with either RPT904 or placebo
Proportion of participants who consumed a single dose of ≥600 mg (ie, a cumulative dose of ≥1044 mg) of peanut or cashew protein, or a single dose of ≥1000 mg (ie, a cumulative dose of ≥2044 mg) of milk, egg, or walnut protein without dose-limiting symptoms at Part 1 DBPCFC
Measured: Approximately 24 weeks
Secondary outcomes (1)
To evaluate safety during treatment with either RPT904 or placebo
Frequency of treatment-emergent adverse events (TEAEs) related to study therapy regimen
Measured: Approximately 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start15 Dec 2025
- Primary completion16 Mar 2027 (estimated)
- Study completion21 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune System DiseasesStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAPT Therapeutics, Inc., a member of the GSK plc group of companies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220811
- Sponsor's protocol ID
- 309960
- Other IDs
- RPT904-01, RPT904-01
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2025
- Last updated
- 6 Nov 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2b Randomized, Double-Blind, Placebo-Controlled Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
- ClinicalTrials.gov ID
- NCT07220811
- Acronym / sponsor ID
- 309960
- Conditions
- Immune System Diseases, Ig-E Mediated Food Allergy
- Keywords
- Ig-E Mediated food allergy, peanut allergy, milk allergy, egg allergy, cashew allergy, walnut allergy, RPT904, placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- RAPT Therapeutics, Inc., a member of the GSK plc group of companiesIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 16 Mar 2027 (estimated)
- Study completion
- 21 Dec 2027 (estimated)
- First posted
- 24 Oct 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.
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy: This is a Phase 2b randomized, double-blind, placebo-controlled clinical trial evaluating RPT904, a next-generation anti-IgE monoclonal antibody, in people with food allergy. RPT904 is a long-acting antibody that may allow for dosing every 8 to 12 weeks. Approximately 100 participants between the ages of 12 and 55 with documented allergy to at least one of the following foods: peanut, milk, egg, cashew, or walnut will be enrolled. In Part 1 (24 weeks), participants will be randomly assigned to receive RPT904 every 8 or 12 weeks (plus a loading dose at Week 2), or placebo. In Part 2 (24 weeks), participants who received RPT904 will continue on their assigned dosing schedule, and those who previously received placebo will be re-randomized to receive RPT904 either every 8 or 12 weeks (plus a loading dose at Week 26). All participants will attend study visits approximately every 2-6 weeks throughout both Part 1 and Part 2 to maintain blinding, regardless of treatment group or dosing frequency. The study is being conducted at multiple sites. The primary goal is to assess whether RPT904 helps participants tolerate higher amounts of a food allergen without dose-limiting allergic symptoms during a food challenge. The study will also monitor the safety and side effects of RPT904 over time. Each participant is expected to be in the study for about 68 to 74 weeks, including screening, treatment, and follow-up.
Detailed description
Phase 2b Randomized, Double-Blind, Placebo-Controlled Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RPT904 (Q8W) | Experimental | Drug: RPT904, Other: PlaceboRPT904 every 8 weeks. The dose levels of RPT904 (150 mg, 300 mg, and 600 mg) within the Q8W cohort will be assigned based on participant weight and baseline total IgE level. RPT904 subcutaneous injection every 8 weeks with a loading dose at Week 2 (Part 1: 24 weeks; Part 2: 24 weeks); matching placebo at intervening visits to maintain blinding. |
| RPT904 (Q12W) | Experimental | Drug: RPT904, Other: PlaceboRPT904 every 12 weeks. The dose levels of RPT904 (150 mg, 300 mg, and 600 mg) will be assigned based on participant weight and baseline total IgE level. RPT904 subcutaneous injection every 12 weeks with a loading dose at Week 2 (Part 1: 24 weeks; Part 2: 24 weeks); matching placebo at intervening visits to maintain blinding. |
| Placebo | Placebo comparator | Drug: RPT904, Other: PlaceboPlacebo subcutaneous injection on schedules matching both the Q8W and Q12W arms in Part 1 (24 weeks); RPT904 every 8 or 12 weeks with a loading dose at Week 26 on schedules matching both the Q8W and Q12W arms Part 2 (24 weeks), with matching placebo at intervening visits to maintain blinding. |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (41 listed)
- Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable.
- Male or female, 12 to less than 56 years of age at screening.
- Allergic to at least 1 of the following foods: peanut, milk, egg, cashew, or walnut, as confirmed by the following criteria:
- a. For participants aged 12 to <18 years:
- i. Allergic to peanut: participant must meet all criteria below:
Key exclusion criteria (8 listed)
- Clinically significant lab abnormalities at screening.
- Sensitivity or suspected/known allergy to any component of the active or placebo OFC material (excluding the test allergens peanut, milk, egg, walnut, and cashew being tested), or drugs related to RPT904 (eg, monoclonal antibodies, polyclonal gamma globulin).
- Uncontrolled or severe asthma/wheezing at screening.
- Current use of oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers (oral or topical).
- Past or current immunotherapy to any study foods within 6 months of screening.
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 |
|---|---|---|
| RPT904Also: ozureprubart, JYB1904Subcutaneous injection once every 8 weeks | Drug | RPT904 (Q8W) |
| RPT904Also: ozureprubart, JYB1904Subcutaneous injection once every 12 weeks | Drug | RPT904 (Q12W) |
| PlaceboSubcutaneous injection at the intervening dosing visits | Other | RPT904 (Q12W), RPT904 (Q8W) |
| RPT904Also: ozureprubart, JYB1904Subcutaneous injection once every 8 weeks (Part 2) | Drug | Placebo |
| RPT904Also: ozureprubart, JYB1904Subcutaneous injection once every 12 weeks (Part 2) | Drug | Placebo |
| PlaceboSubcutaneous injection on schedules matching both the Q8W and Q12W arms (Part 1). Subcutaneous injection at the intervening dosing visits (Part 2) | Other | Placebo |
Primary outcome
To compare the ability to consume a food without dose-limiting symptoms during a DBPCFC at the end of Part 1 after treatment with either RPT904 or placebo
Time frame: Approximately 24 weeks
Proportion of participants who consumed a single dose of ≥600 mg (ie, a cumulative dose of ≥1044 mg) of peanut or cashew protein, or a single dose of ≥1000 mg (ie, a cumulative dose of ≥2044 mg) of milk, egg, or walnut protein without dose-limiting symptoms at Part 1 DBPCFC
1 secondary outcome
To evaluate safety during treatment with either RPT904 or placebo
Time frame: Approximately 48 weeks
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 6 Nov 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.
37 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RPT904 in people with Immune System Diseases and Ig-E Mediated Food Allergy, run by RAPT Therapeutics, Inc., a member of the GSK plc group of companies at 37 sites in 3 countries.
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 41 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Australia, Canada. 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. 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 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.
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?
To compare the ability to consume a food without dose-limiting symptoms during a DBPCFC at the end of Part 1 after treatment with either RPT904 or placebo (time frame: Approximately 24 weeks). 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 6 Nov 2026.