Hereditary AngioedemaPhase 3RAPIDe-3NCT06343779
Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
A Phase 3 study of Hereditary Angioedema and Hereditary Angioedema Type I, run by Pharvaris Netherlands B.V. at 76 sites in 29 countries.
Trial summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand treatment of HAE attacks, including non-severe laryngeal attacks, in participants ≥12 to… Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Hereditary Angioedema, Hereditary Angioedema Type I, Hereditary Angioedema Type II
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 76 sitesin 29 countries
- Study dates
- 26 Feb 2024to 17 Oct 2025
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Provision of written informed consent/assent.
- Male or female, aged ≥12 to ≤75 years at the time of providing written informed consent/assent.
- Diagnosis of HAE-1/2/3.
- History of at least 2 HAE attacks in the last 3 months before screening.
- Experience with using standard-of-care treatment to effectively manage on-demand treatment for HAE attacks.
- Participants on long-term prophylactic therapy with plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat, or lanadelumab) must be on a stable dose and regimen and intend to remain on the same dose for 6 months before screening and the duration of the study. OR, Participant has stopped using plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat) at least 2 weeks or lanadelumab at least 10 weeks before screening.
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- Capable of recording, without assistance, electronic HAE diary and ePRO data using an electronic device.
- For adolescent participants aged ≥12 and <18 years of age: body weight ≥40 kg.
- Female participants of childbearing potential must agree to the protocol specified pregnancy testing and contraception methods.
Who cannot join
- Any female who is pregnant, plans to become pregnant, or is breastfeeding.
- Any diagnosis of angioedema other than HAE.
- Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.
- Use of attenuated androgens for short-term prophylaxis within 2 weeks before screening.
- Abnormal hepatic function.
- Abnormal renal function (eGFR <60 ml/min/1.73 m2).
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- History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse.
- Has received prior on-demand HAE treatment with deucrictibant.
- Currently participating in any other investigational drug study or receiving other investigational treatment within the last 30 days, or within 5 half-lives (whichever is longer) of the time of randomization.
- Prior gene therapy for any indication at any time.
- Use of concomitant medications with systemic absorption that are strong inhibitors of CYP3A4 or strong inducers of CYP3A4 within the last 30 days, or within 5 half-lives (whichever is longer) of the time of randomization.
- Known hypersensitivity to study drug or any of the excipients of study drug.
Trial locations and contacts
76 sites in 29 countries.
76 sites in 29 countries
United States13 sites
Study Site
Birmingham, Alabama, 35209
Study Site
Boston, Massachusetts, 02115
Study Site
Chevy Chase, Maryland, 20815
Study Site
Colorado Springs, Colorado, 80907-6231
Study Site
Dallas, Texas, 75231
Study Site
Detroit, Michigan, 48202
Study Site
Hershey, Pennsylvania, 17033
Study Site
Little Rock, Arkansas, 72205
Study Site
Paradise Valley, Arizona, 85258
Study Site
San Diego, California, 92122
Study Site
Santa Monica, California, 90404
Study Site
St Louis, Missouri, 63141
Study Site
Walnut Creek, California, 94598
Italy6 sites
Study Site
Catania, 95124
Study Site
Milan, 20138
Study Site
Milan, 20097
Study Site
Padova, 35128
Study Site
Palermo, 90146
Study Site
Roma, 00133
United Kingdom6 sites
Study Site
Bristol, BS10 5NB
Study Site
Camberley, GU16 7UJ
Study Site
Cambridge, CB2 0QQ
Study Site
Leeds, LS9 7TF
Study Site
London, E1 2ES
Study Site
Plymouth, PL6 8DH
Brazil5 sites
Study Site
Paraná, 80810-100
Study Site
Ribeirão Preto, 14048-900
Study Site
Salvador, 41950-640
Study Site
Santo André, 09060-870
Study Site
São Paulo, 05403-000
Japan5 sites
Study Site
Chiba, 260-8677
Study Site
Hiroshima, 730-8518
Study Site
Kanagawa, 216-8511
Study Site
Osaka, 569-8686
Study Site
Tokyo, 113-8431
Colombia4 sites
Study Site
Bogotá, 00
Study Site
Bogotá, 111221
Study Site
Bogotá, 111711
Study Site
Medellín, 050021
Germany4 sites
Study Site
Berlin, 12203
Study Site
Frankfurt am Main, 60590
Study Site
Frankfurt am Main, 60596
Study Site
Lübeck, 23538
Austria3 sites
Study Site
Graz, 8036
Study Site
Linz, 4021
Study Site
Vienna, 1090
Turkey (Türkiye)3 sites
Study Site
Ankara, 06203
Study Site
Istanbul, 34093
Study Site
Izmir, 35100
Australia2 sites
Study Site
Box Hill, 3128
Study Site
Campbelltown, New South Wales, 2560
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Cross-over Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults With Hereditary Angioedema
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand treatment of HAE attacks, including non-severe laryngeal attacks, in participants ≥12 to ≤75 years of age with HAE type 1, type 2, or type 3, a proportion of whom are using long-term prophylactic medication for HAE.
Read the detailed description
The study consists of a Screening Phase during which eligibility is confirmed, a Treatment Phase in which participants will be randomized and receive double blinded study drug to treat 2 qualifying HAE attacks (i.e., 2 Treatment Periods within the Treatment Phase), and an End-of-Study Follow-up Phase after the second attack treated with study drug. In addition, for adolescent participants (age ≥12 to <18 years), PK samples are collected after administration of deucrictibant at Day 1 in a non-attack state.
- Conditions
- Hereditary Angioedema, Hereditary Angioedema Type I, Hereditary Angioedema Type II, Hereditary Angioedema Types I and II, Hereditary Angioedema Attack, Hereditary Angioedema With C1 Esterase Inhibitor Deficiency
- Being tested
- Deucrictibant, Placebo
- Keywords
- HAE, HAE Type I, HAE Type II, Oral Treatment, Bradykinin B2 Receptor Antagonists, PHVS416, PHA121, On-Demand, Deucrictibant, Pharvaris, HAE Type III
- Medical subject headings
- Angioedemas, Hereditary, Hereditary Angioedema Types I and II, Hereditary Angioedema Type III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deucrictibant, PlaceboDrug
Deucrictibant Soft Capsules for Oral Use
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Deucrictibant administered for first HAE attack, placebo administered for second HAE attack. Receives: Drug: Deucrictibant, Placebo |
| Arm 2 | Experimental | Placebo administered for first HAE attack, deucrictibant administered for second HAE attack. Receives: Drug: Deucrictibant, Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to onset of symptom relief, defined as Patient Global Impression of Change (PGI-C) rating of at least "a little better" for 2 consecutive timepoints within 12 hours post-treatment.
The PGI-C (7-point scale) is used to evaluate the change in the HAE attack symptoms as compared to pre-treatment.
Measured: Pre-treatment to 12 hours post-treatment.
Secondary outcomes (11)
Proportion of study drug-treated attacks achieving PGI-C rating of at least "a little better" at 4 hours post-treatment.
The PGI-C (7-point scale) is used to evaluate the change in the HAE attack symptoms as compared to pre-treatment.
Measured: Pre-treatment to 4 hours post-treatment.
Time to substantial symptom relief, defined as achieving PGI-C rating of at least "better" for 2 consecutive timepoints within 12 hours post-treatment.
The PGI-C (7-point scale) is used to evaluate the change in the HAE attack symptoms as compared to pre-treatment.
Measured: Pre-treatment to 12 hours post-treatment.
Time to substantial symptom relief by Patient Global Impression of Severity (PGI-S).
Defined as achieving ≥1 point reduction in PGI-S (5-point scale) from pre-treatment for 2 consecutive timepoints within 12 hours post-treatment.
Measured: Pre-treatment to 12 hours post-treatment.
Time to complete symptom resolution, defined as achieving PGI-S rating of "none" within 48 hours post-treatment.
The PGI-S (5-point scale) is used to evaluate the severity of HAE attack symptoms.
Measured: Pre-treatment to 48 hours post-treatment.
Time to End of Progression (EoP) in attack symptoms within 12 hours.
EoP time defined as the earliest post-treatment timepoint after which all subsequent PGI-C ratings are stable or improved.
Measured: Pre-treatment to 12 hours post-treatment.
Proportion of study drug-treated attacks requiring rescue medication within 24 hours post-treatment.
Rescue medication is defined as the participant's usual acute on-demand HAE treatment taken if symptoms persist or progress after study drug administration.
Measured: Pre-treatment to 24 hours post-treatment.
Proportion of attacks achieving symptom resolution.
Defined as achieving PGI-S rating of "none" with one dose of study drug at 24 hours post-treatment.
Measured: Pre-treatment to 24 hours post-treatment.
Time to substantial symptom relief by Angioedema Symptom Rating Scale (AMRA).
Defined as a ≥50% reduction in AMRA composite score from pre-treatment for 2 consecutive timepoints within 12 hours post-treatment.
Measured: Pre-treatment to 12 hours post-treatment.
Time to almost complete or complete symptom relief by AMRA.
Defined as all item scores in AMRA having a value ≤10 for 2 consecutive timepoints within 24 hours post-treatment.
Measured: Pre-treatment to 24 hours post-treatment.
Proportion of study drug-treated attacks reaching almost complete or complete symptom relief by AMRA.
Defined as all item scores in AMRA having a value ≤10 at 24 hours post-treatment.
Measured: Pre-treatment to 24 hours post-treatment.
Time to EoP in attack symptoms within 12 hours.
Defined as the earliest post-treatment timepoint after which every individual AMRA item is stable or improved at all subsequent timepoints.
Measured: Pre-treatment to 12 hours post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start26 Feb 2024
- Primary completion17 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hereditary AngioedemaStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharvaris Netherlands B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Pharvaris, Study director, Pharvaris Netherlands B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343779
- Sponsor's protocol ID
- PHA022121-C306
- Acronym
- RAPIDe-3
- Status last verified
- Nov 2025
- First submitted
- 18 Mar 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Riedl MA, Li PH, Adatia A, Cancian M, Stobiecki M, Valerieva A, Grumach AS, Lumry WR, Soteres DF, Brodszki N, Fili NL, Hakl R, Kang HR, Karakaya G, Kranke B, Li HH, Peter J, Recke A, Tachdjian R, Triggianese P, Zanichelli A, Anderson J, Aygoren-Pursun E, Craig TJ, Farkas H, Giardino F, Giavina-Bianchi P, Kim S, Kinaciyan T, Martinez-Saguer I, Perego F, Sitz KV, Staevska M, Wedner HJ, Zaragoza-Urdaz RH, Zwiener RD, Gelincik A, Arcoleo F, Arnaout R, Baptist AP, de Albuquerque Campos R, Dorr AD, Ferriani MPL, Fukunaga A, Gobert D, Gurugama P, Hide M, Hong DI, Inage E, Jacobs JS, Katelaris CH, Leeman L, Lleonart R, Magerl M, Manning ME, Mano S, Ooka S, Ramos CJ, Liu J, Zhu L, Mendivil J, Katbeh U, Giannattasio G, Crabbe R, Yu M, Lesage A, Lu P, Cohn DM. Oral deucrictibant for on-demand treatment of hereditary angioedema attacks: a phase 3, multicentre, randomised, double-blind, placebo-controlled crossover trial. Lancet. 2026 Oct 8:S0140-6736(26)01296-1. doi: 10.1016/S0140-6736(26)01296-1. Online ahead of print.
PubMed 42849489
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled, Cross-over Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults With Hereditary Angioedema
- ClinicalTrials.gov ID
- NCT06343779
- Acronym / sponsor ID
- RAPIDe-3 / PHA022121-C306
- Conditions
- Hereditary Angioedema, Hereditary Angioedema Type I, Hereditary Angioedema Type II, Hereditary Angioedema Types I and II, Hereditary Angioedema Attack, Hereditary Angioedema With C1 Esterase Inhibitor Deficiency
- Keywords
- HAE, HAE Type I, HAE Type II, Oral Treatment, Bradykinin B2 Receptor Antagonists, PHVS416, PHA121, On-Demand
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Pharvaris Netherlands B.V.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 3 Apr 2024 (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 Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand treatment of HAE attacks, including non-severe laryngeal attacks, in participants ≥12 to ≤75 years of age with HAE type 1, type 2, or type 3, a proportion of whom are using long-term prophylactic medication for HAE.
Detailed description
The study consists of a Screening Phase during which eligibility is confirmed, a Treatment Phase in which participants will be randomized and receive double blinded study drug to treat 2 qualifying HAE attacks (i.e., 2 Treatment Periods within the Treatment Phase), and an End-of-Study Follow-up Phase after the second attack treated with study drug. In addition, for adolescent participants (age ≥12 to <18 years), PK samples are collected after administration of deucrictibant at Day 1 in a non-attack state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Deucrictibant, PlaceboDeucrictibant administered for first HAE attack, placebo administered for second HAE attack. |
| Arm 2 | Experimental | Drug: Deucrictibant, PlaceboPlacebo administered for first HAE attack, deucrictibant administered for second HAE attack. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of written informed consent/assent.
- Male or female, aged ≥12 to ≤75 years at the time of providing written informed consent/assent.
- Diagnosis of HAE-1/2/3.
- History of at least 2 HAE attacks in the last 3 months before screening.
- Experience with using standard-of-care treatment to effectively manage on-demand treatment for HAE attacks.
Key exclusion criteria (12 listed)
- Any female who is pregnant, plans to become pregnant, or is breastfeeding.
- Any diagnosis of angioedema other than HAE.
- Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.
- Use of attenuated androgens for short-term prophylaxis within 2 weeks before screening.
- Abnormal hepatic function.
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 |
|---|---|---|
| Deucrictibant, PlaceboDeucrictibant Soft Capsules for Oral Use | Drug | Arm 1, Arm 2 |
Primary outcome
Time to onset of symptom relief, defined as Patient Global Impression of Change (PGI-C) rating of at least "a little better" for 2 consecutive timepoints within 12 hours post-treatment.
Time frame: Pre-treatment to 12 hours post-treatment.
The PGI-C (7-point scale) is used to evaluate the change in the HAE attack symptoms as compared to pre-treatment.
11 secondary outcomes
Proportion of study drug-treated attacks achieving PGI-C rating of at least "a little better" at 4 hours post-treatment.
Time frame: Pre-treatment to 4 hours post-treatment.
Time to substantial symptom relief, defined as achieving PGI-C rating of at least "better" for 2 consecutive timepoints within 12 hours post-treatment.
Time frame: Pre-treatment to 12 hours post-treatment.
Time to substantial symptom relief by Patient Global Impression of Severity (PGI-S).
Time frame: Pre-treatment to 12 hours post-treatment.
Time to complete symptom resolution, defined as achieving PGI-S rating of "none" within 48 hours post-treatment.
Time frame: Pre-treatment to 48 hours post-treatment.
Time to End of Progression (EoP) in attack symptoms within 12 hours.
Time frame: Pre-treatment to 12 hours post-treatment.
Proportion of study drug-treated attacks requiring rescue medication within 24 hours post-treatment.
Time frame: Pre-treatment to 24 hours post-treatment.
Proportion of attacks achieving symptom resolution.
Time frame: Pre-treatment to 24 hours post-treatment.
Time to substantial symptom relief by Angioedema Symptom Rating Scale (AMRA).
Time frame: Pre-treatment to 12 hours post-treatment.
Time to almost complete or complete symptom relief by AMRA.
Time frame: Pre-treatment to 24 hours post-treatment.
Proportion of study drug-treated attacks reaching almost complete or complete symptom relief by AMRA.
Time frame: Pre-treatment to 24 hours post-treatment.
Time to EoP in attack symptoms within 12 hours.
Time frame: Pre-treatment to 12 hours post-treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Derived from this study: PubMed 42849489Riedl MA, Li PH, Adatia A, Cancian M, Stobiecki M, Valerieva A, Grumach AS, Lumry WR, Soteres DF, Brodszki N, Fili NL, Hakl R, Kang HR, Karakaya G, Kranke B, Li HH, Peter J, Recke A, Tachdjian R, Triggianese P, Zanichelli A, Anderson J, Aygoren-Pursun E, Craig TJ, Farkas H, Giardino F, Giavina-Bianchi P, Kim S, Kinaciyan T, Martinez-Saguer I, Perego F, Sitz KV, Staevska M, Wedner HJ, Zaragoza-Urdaz RH, Zwiener RD, Gelincik A, Arcoleo F, Arnaout R, Baptist AP, de Albuquerque Campos R, Dorr AD, Ferriani MPL, Fukunaga A, Gobert D, Gurugama P, Hide M, Hong DI, Inage E, Jacobs JS, Katelaris CH, Leeman L, Lleonart R, Magerl M, Manning ME, Mano S, Ooka S, Ramos CJ, Liu J, Zhu L, Mendivil J, Katbeh U, Giannattasio G, Crabbe R, Yu M, Lesage A, Lu P, Cohn DM. Oral deucrictibant for on-demand treatment of hereditary angioedema attacks: a phase 3, multicentre, randomised, double-blind, placebo-controlled crossover trial. Lancet. 2026 Oct 8:S0140-6736(26)01296-1. doi: 10.1016/S0140-6736(26)01296-1. Online ahead of print.
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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.
Study Director, Pharvaris study director
Pharvaris Netherlands B.V.
76 sites in 29 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Hereditary Angioedema and Hereditary Angioedema Type I, run by Pharvaris Netherlands B.V. at 76 sites in 29 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 9 inclusion and 12 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: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in United States, Italy, United Kingdom, Brazil, Japan and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to onset of symptom relief, defined as Patient Global Impression of Change (PGI-C) rating of at least "a little better" for 2 consecutive timepoints within 12 hours post-treatment. (time frame: Pre-treatment to 12 hours post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06343779, which also lists 1 linked publication.
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 21 Nov 2025.