Stable Coronary Artery DiseasePhase 2NCT07884136
RBD1119 in Coronary Artery Disease (CAD)
A Phase 2 study testing RBD1119 in people with Stable Coronary Artery Disease, run by Ribocure Pharmaceuticals AB at 16 sites in 2 countries.
Trial summary
CAD is driven by atherosclerosis in the coronary arteries and is a major cause of myocardial infarction, heart failure, arrhythmias, and premature death. Despite contemporary secondary prevention including lipid lowering, revascularization when indicated, and antiplatelet therapy, participants with established CAD… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stable Coronary Artery Disease
- What is being tested?
- RBD1119
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 16 Oct 2026to 18 Mar 2028
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to give written informed consent for participation in the trial.
- Male or female participants age ≥50 years. For male participants, those who are potent and sexually active with a female partner of childbearing potential must agree to use effective male contraception during the trial, defined as either vasectomy with a confirmed negative semen analysis or use of a male condom. In addition, the female partner must use appropriate contraception during the trial and for at least 6 months after the participant's last dose of trial treatment. Female participants must be post-menopausal (≥12 months spontaneous amenorrhea without other cause, or FSH thresholds if needed) or permanently sterile for at least 6 months prior to dosing (eg, bilateral oophorectomy, total hysterectomy, bilateral tubal ligation) or use highly effective contraception from Screening, for the duration of trial treatment and for the specified post treatment period (see Appendix 3).
- Age ≥55 years with ≥12 months of spontaneous amenorrhea, or
- Age <55 years with ≥12 months of spontaneous amenorrhea and FSH in the postmenopausal range, or surgical menopause (bilateral oophorectomy, with or without hysterectomy) documented in the medical history.
- Stable, documented atherosclerotic CAD (ESC Chronic Coronary Syndromes): Asymptomatic or symptomatic CCS with objective documentation of atherosclerotic/obstructive CAD, and clinically stable, defined as:
- ≥6 months since the initial documented diagnosis of CAD, and
Show all 14Show fewer
- if prior PCI or ACS: ≥6 months since the most recent event, and
- if prior CABG: ≥12 months since the most recent CABG, and
- Objective documentation must include ≥1 of the following:
- History of ACS (unstable angina, NSTEMI, STEMI) attributable to atherosclerotic CAD, or
- Prior coronary revascularization (PCI or CABG), or
- Obstructive CAD on imaging: ≥50% luminal stenosis in ≥1 epicardial coronary artery on invasive coronary angiography or computed tomography coronary angiography.
- Ongoing treatment with a low dose aspirin 75-100 mg for at least 30 days prior randomization
- Stable standard of care treatment (ie, ongoing since at least 30 days prior to randomization) that is intended to continue unchanged during the trial
Who cannot join
- Women who are pregnant, currently breastfeeding, or planning pregnancy during the trial or within the defined post treatment period are not eligible.
- Ischemia with non-obstructive coronary arteries/ Angina with non-obstructive coronary arteries /vasospastic/microvascular angina or suspected CAD without objective evidence of obstructive atherosclerotic CAD at screening.
- Any clinical suspicion of acute coronary syndrome or unstable angina at randomization according to ESC criteria:
- Rest angina (pain of characteristic nature and location occurring at rest and for prolonged periods >20 min).
- New-onset angina (recent [≤2 months] onset of moderate-to-severe angina, Canadian Cardiovascular Society grade II or III).
- Crescendo angina (previous stable angina that progressively increases in severity and intensity and occurs at a lower threshold over a short period of time).
Show all 42Show fewer
- Presence of ≥2 minor or ≥1 major bleeding risk criterion at screening as defined below:
- Minor Criteria
- Age ≥75 years
- Hemoglobin 11-12.9 g/dL for men and 11-11.9 g/dL for women
- One event of spontaneous bleeding requiring hospitalization or transfusion ≥6 months ago
- Long-term use of oral NSAIDs or corticosteroids
- Ischemic stroke >6 months ago Major Criteria
- Ongoing indication (including but not limited to atrial fibrillation, venous thromboembolism, mechanical cardiac valves) for or anticipated use of long-term oral anticoagulation (DOAC, VKA or LMWH or other similar anticoagulants)
- Severe or end-stage chronic kidney disease (estimated glomerular filtration rate <30 mL/min)
- Hemoglobin <11 g/dL
- Spontaneous bleeding requiring hospitalization or transfusion in the past 6 months or at any time if recurrent (≥2 occasions)
- Platelet count <100 × 109/L.
- Chronic bleeding diathesis or family history thereof.
- Liver cirrhosis with portal hypertension
- Active malignancy - (excluding nonmelanoma skin cancer) within the past 12 months
- Previous spontaneous intracranial hemorrhage (at any time)
- Previous traumatic intracranial hemorrhage within the past 12 months
- Presence of a brain arterio-venous malformation
- Ischemic stroke within the past 6 months.
- Use of DAPT at the time of randomization.
- Major surgery during the last 30 days before screening or planned major surgery or intervention within the trial period.
- New York Heart Association class III-IV heart failure at screening or randomization, hospitalization for exacerbation of chronic heart failure within the previous 12 months, or other indices of unstable heart failure.
- Documented left ventricular ejection fraction <30% at screening, based on available prior or current assessment.
- Clinically significant arrhythmia associated with hemodynamic instability or impaired organ perfusion, unless adequately controlled with stable therapeutic management for at least 3 months prior to Screening
- Liver chemistry abnormalities at Screening (central laboratory reference ranges): exclusion if any of the following apply:
- ALT and/or AST > 1.5 × ULN; and/or
- Total bilirubin > 1.5 × ULN (participants with documented Gilbert's syndrome: exclude only if total bilirubin > 3.0 × ULN and/or direct bilirubin > 1.5 × ULN); and/or
- Gamma-glutamyl transferase (gamma-glutamyl transpeptidase ) > 2.0 × ULN
- Expected survival time < 1 year due to non-cardiac disorders.
- Clinically significant acute illness within 7 days before the first dose of trial drug.
- Donation of > 300 mL of blood within 56 days before the first dose of trial drug.
- History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc.
- History of severe intolerance to subcutaneous injection (minor reactions such as localized swelling or redness are permitted).
- Receipt of an investigational product within 30 days or 5 half-lives (whichever is longer) before the first dose of the trial drug, or current participation in the follow-up phase of another clinical trial. Any prior use of advanced therapies (ASO/siRNA/gene therapy/cell therapy) should be evaluated and judged by the Investigator.
- Any underlying disease, or surgical or medical condition that, in the opinion of the Investigator, might interfere with the participant's ability to comply with the protocol or with the interpretation of the clinical trial results.
- Evidence of active HBV, HCV, or HIV infection at screening, defined as: HBsAg positive; anti HCV positive with clinical/laboratory evidence of active or chronic hepatitis as assessed by the Investigator (participants with documented resolved/treated HCV and no evidence of active disease may be eligible); or HIV-1/2 Ag/Ab reactive with confirmatory test positive.
Trial locations and contacts
16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 2 countries
Poland11 sites
Gabinet Kardiologiczno-Internistyczny
Gdynia
Marek Piepiorka
Cardiology Department, SPS Szpital Zachodni im św Jana Pawła II
Grodzisk Mazowiecki
Janusz Bednarski
Centrum Medyczne Vitamedicum itw
Krakow
Justyna Irla-Czyzycka
Specjalistyczna Praktyka Lekarska Ewa Mirek Bryniarska
Krakow
Ewa Mirek-Bryniarska
Department of Cardiology, The Copper Health Centre MCZ
Lubin
Adrian Wlodarczak
Velocity Nova Sp. z o.o. site: Velocity Lublin
Lublin
Piotr Fic
balsam MEDICA medical centre
Warsaw
Pawel Balsam
Centrum Medyczne LUX MED (LUX MED Sp. z o.o.)
Warsaw
Piotr Pruszczyk
Klinika Sienna
Warsaw
Jacek Opalinski
Przychodnia Care Access Warszawa
Warsaw
Anna Platek
Velocity Nova Sp. z o.o. site: Velocity Zamość
Zamość
Wojciech Czochra
Sweden5 sites
Kardiologi VO Hjärt- och lungmedicin
Lund
David Erlinge
Ribocure Clinic
Mölndal
Sara Svedlund
Örebro University Hospital
Örebro
Ole Fröbert
Dalecarlia Clinical Research Center
Rättvik
Hans Larnefeldt
Clinical Trial Consultants Stockholm
Stockholm
Kaveh Azizi
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Trial to Evaluate Safety, and Pharmacodynamics of Repeated Subcutaneously Administered RBD1119 in Participants With CAD
CAD is driven by atherosclerosis in the coronary arteries and is a major cause of myocardial infarction, heart failure, arrhythmias, and premature death. Despite contemporary secondary prevention including lipid lowering, revascularization when indicated, and antiplatelet therapy, participants with established CAD, particularly those post-ACS, remain at clinically meaningful residual risk of recurrent atherothrombotic events.
Intensifying antithrombotic therapy can reduce ischemic events but typically increases bleeding, as exemplified by the addition of low dose rivaroxaban to aspirin in stable atherosclerotic disease. This persistent efficacy-safety trade-off supports development of antithrombotic approaches that reduce pathological thrombosis while preserving hemostasis.
Read more
RBD1119 is a GalNAc-conjugated siRNA that targets factor XI mRNA in hepatocytes. The GalNAc moiety binds the asialoglycoprotein receptor on hepatocyte surfaces, enabling receptor mediated endocytosis and preferential hepatic uptake. Once internalized, RBD1119 mediates cleavage of factor XI mRNA via the RNA interference pathway, reducing hepatic factor XI expression and lowering circulating factor XI levels.
This multicenter, randomized, double-blind, placebo-controlled, phase II trial will evaluate the PD, safety, and PK of subcutaneously administered RBD1119 in participants with stable coronary artery disease (CAD).
Read the detailed description
CAD is caused by atherosclerosis in the coronary arteries and remains a leading cause of MI, heart failure, arrhythmias, and premature death, with substantial residual risk of recurrent atherothrombotic events even after standard secondary prevention. More intensive antithrombotic therapy can lower ischemic events, but this benefit is often offset by increased bleeding, highlighting the need for treatments that better separate antithrombotic efficacy from bleeding risk. Factor XI, part of the intrinsic coagulation pathway, has emerged as a promising target because its inhibition reduces thrombin amplification and prolongs aPTT without affecting prothrombin time, suggesting potential for safer anticoagulation with less disruption of normal hemostasis.
The trial comprises screening, treatment, and long-term safety follow-up periods. Participants will be allocated to one of three different dose levels of RBD1119 or placebo: low-dose (n=40), medium-dose (n=60), high-dose (n=60) or placebo (n=40). Approximately 200 participants will be randomized.
Randomization to the RBD1119 low-dose dose group and corresponding placebo proceeds without dose-specific staggering. Randomization to the medium-dose group is initially limited to 10 participants, comprising 8 participants assigned to RBD1119 medium-dose and 2 assigned to placebo. Further randomization is paused until participants have received Dose X on Day Y and completed safety follow-up through Day 43. Randomization resumes only after IDMC review, a recommendation to continue, and Sponsor authorization. Initiation of the high-dose group requires prior IDMC review of the initial medium-dose cohort and Sponsor authorization. The same initial cohort, safety follow-up, IDMC review, and authorization process is then applied to the high-dose group. A planned IDMC review will not be delayed solely because fewer than all 10 participants in an initial dose cohort have received the second dose or completed follow-up through Day 43.
- Conditions
- Stable Coronary Artery Disease
- Being tested
- RBD1119, Placebo
- Keywords
- siRNA, Phase 2, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBD1119Drug
RBD1119, active drug
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | Not described Receives: Drug: RBD1119; Drug: Placebo |
| Medium-dose group | Experimental | Not described Receives: Drug: RBD1119; Drug: Placebo |
| High-dose group | Experimental | Not described Receives: Drug: RBD1119; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective
To measure the effect of RBD1119 on blood coagulation factor XI activity.
Measured: Week 8
Primary endpoint
Change from baseline in blood coagulation factor XI activity.
Measured: Week 8
Secondary outcomes (5)
Secondary objective
To measure the number and severity of adverse advents during treatment with RBD1119.
Measured: Up to week 44
Secondary objective
To measure the plasma concentration of RBD1119.
Measured: 0 [pre-dose] to 24 hours after dosing
Secondary objective
To measure the effect of RBD1119 on blood coagulation time measured with aPTT .
Measured: Up to week 44
Secondary objective
To measure the effect of RBD1119 on blood coagulation time measured with PT/INR.
Measured: Up to week 44
Secondary objective
To measure the effect of RBD1119 on coagulation factor XI antigen plasma concentration.
Measured: Up to week 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start16 Oct 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion18 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Coronary Artery DiseaseStudies 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
- Model description
- Randomization to the RBD1119 low-dose group and corresponding placebo proceeds without dose-specific staggering. Randomization to the medium-dose group is initially limited to 10 participants, comprising 8 participants assigned to RBD1119 medium-dose and 2 assigned to placebo. Further randomization is paused until participants have received Dose X on Day Y and completed safety follow-up through Day 43. Randomization resumes only after IDMC review, a recommendation to continue, and Sponsor authorization. Initiation of the high-dose group requires prior IDMC review of the initial medium-dose cohort and Sponsor authorization. The same initial cohort, safety follow-up, IDMC review, and authorization process is then applied to the high-dose group. A planned IDMC review will not be delayed solely because fewer than all 10 participants in an initial dose cohort have received the second dose or completed follow-up through Day 43.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ribocure Pharmaceuticals AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Responsible party
- Sponsor
- Investigators
- Anders Gabrielsen, Study director, Ribocure Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884136
- Sponsor's protocol ID
- RC05T002
- Other IDs
- 2026-525901-10
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase II Trial to Evaluate Safety, and Pharmacodynamics of Repeated Subcutaneously Administered RBD1119 in Participants With CAD
- ClinicalTrials.gov ID
- NCT07884136
- Acronym / sponsor ID
- RC05T002
- Conditions
- Stable Coronary Artery Disease
- Keywords
- siRNA, Phase 2, RCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ribocure Pharmaceuticals ABIndustry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Study start
- 16 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 18 Mar 2028 (estimated)
- First posted
- 20 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.
CAD is driven by atherosclerosis in the coronary arteries and is a major cause of myocardial infarction, heart failure, arrhythmias, and premature death. Despite contemporary secondary prevention including lipid lowering, revascularization when indicated, and antiplatelet therapy, participants with established CAD, particularly those post-ACS, remain at clinically meaningful residual risk of recurrent atherothrombotic events.
Intensifying antithrombotic therapy can reduce ischemic events but typically increases bleeding, as exemplified by the addition of low dose rivaroxaban to aspirin in stable atherosclerotic disease. This persistent efficacy-safety trade-off supports development of antithrombotic approaches that reduce pathological thrombosis while preserving hemostasis.
RBD1119 is a GalNAc-conjugated siRNA that targets factor XI mRNA in hepatocytes. The GalNAc moiety binds the asialoglycoprotein receptor on hepatocyte surfaces, enabling receptor mediated endocytosis and preferential hepatic uptake. Once internalized, RBD1119 mediates cleavage of factor XI mRNA via the RNA interference pathway, reducing hepatic factor XI expression and lowering circulating factor XI levels.
This multicenter, randomized, double-blind, placebo-controlled, phase II trial will evaluate the PD, safety, and PK of subcutaneously administered RBD1119 in participants with stable coronary artery disease (CAD).
Detailed description
CAD is caused by atherosclerosis in the coronary arteries and remains a leading cause of MI, heart failure, arrhythmias, and premature death, with substantial residual risk of recurrent atherothrombotic events even after standard secondary prevention. More intensive antithrombotic therapy can lower ischemic events, but this benefit is often offset by increased bleeding, highlighting the need for treatments that better separate antithrombotic efficacy from bleeding risk. Factor XI, part of the intrinsic coagulation pathway, has emerged as a promising target because its inhibition reduces thrombin amplification and prolongs aPTT without affecting prothrombin time, suggesting potential for safer anticoagulation with less disruption of normal hemostasis.
The trial comprises screening, treatment, and long-term safety follow-up periods. Participants will be allocated to one of three different dose levels of RBD1119 or placebo: low-dose (n=40), medium-dose (n=60), high-dose (n=60) or placebo (n=40). Approximately 200 participants will be randomized.
Randomization to the RBD1119 low-dose dose group and corresponding placebo proceeds without dose-specific staggering. Randomization to the medium-dose group is initially limited to 10 participants, comprising 8 participants assigned to RBD1119 medium-dose and 2 assigned to placebo. Further randomization is paused until participants have received Dose X on Day Y and completed safety follow-up through Day 43. Randomization resumes only after IDMC review, a recommendation to continue, and Sponsor authorization. Initiation of the high-dose group requires prior IDMC review of the initial medium-dose cohort and Sponsor authorization. The same initial cohort, safety follow-up, IDMC review, and authorization process is then applied to the high-dose group. A planned IDMC review will not be delayed solely because fewer than all 10 participants in an initial dose cohort have received the second dose or completed follow-up through Day 43.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomization to the RBD1119 low-dose group and corresponding placebo proceeds without dose-specific staggering. Randomization to the medium-dose group is initially limited to 10 participants, comprising 8 participants assigned to RBD1119 medium-dose and 2 assigned to placebo. Further randomization is paused until participants have received Dose X on Day Y and completed safety follow-up through Day 43. Randomization resumes only after IDMC review, a recommendation to continue, and Sponsor authorization. Initiation of the high-dose group requires prior IDMC review of the initial medium-dose cohort and Sponsor authorization. The same initial cohort, safety follow-up, IDMC review, and authorization process is then applied to the high-dose group. A planned IDMC review will not be delayed solely because fewer than all 10 participants in an initial dose cohort have received the second dose or completed follow-up through Day 43.
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | Experimental | Drug: RBD1119, Drug: Placebo |
| Medium-dose group | Experimental | Drug: RBD1119, Drug: Placebo |
| High-dose group | Experimental | Drug: RBD1119, Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Willing and able to give written informed consent for participation in the trial.
- Male or female participants age ≥50 years. For male participants, those who are potent and sexually active with a female partner of childbearing potential must agree to use effective male contraception during the trial, defined as either vasectomy with a confirmed negative semen analysis or use of a male condom. In addition, the female partner must use appropriate contraception during the trial and for at least 6 months after the participant's last dose of trial treatment. Female participants must be post-menopausal (≥12 months spontaneous amenorrhea without other cause, or FSH thresholds if needed) or permanently sterile for at least 6 months prior to dosing (eg, bilateral oophorectomy, total hysterectomy, bilateral tubal ligation) or use highly effective contraception from Screening, for the duration of trial treatment and for the specified post treatment period (see Appendix 3).
- Stable, documented atherosclerotic CAD (ESC Chronic Coronary Syndromes): Asymptomatic or symptomatic CCS with objective documentation of atherosclerotic/obstructive CAD, and clinically stable, defined as:
- Ongoing treatment with a low dose aspirin 75-100 mg for at least 30 days prior randomization
- Stable standard of care treatment (ie, ongoing since at least 30 days prior to randomization) that is intended to continue unchanged during the trial
Key exclusion criteria (42 listed)
- Women who are pregnant, currently breastfeeding, or planning pregnancy during the trial or within the defined post treatment period are not eligible.
- Ischemia with non-obstructive coronary arteries/ Angina with non-obstructive coronary arteries /vasospastic/microvascular angina or suspected CAD without objective evidence of obstructive atherosclerotic CAD at screening.
- Any clinical suspicion of acute coronary syndrome or unstable angina at randomization according to ESC criteria:
- Presence of ≥2 minor or ≥1 major bleeding risk criterion at screening as defined below:
- Minor Criteria
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 |
|---|---|---|
| RBD1119RBD1119, active drug | Drug | High-dose group, Low-dose group, Medium-dose group |
| PlaceboPlacebo | Drug | High-dose group, Low-dose group, Medium-dose group |
Primary outcome
Primary objective
Time frame: Week 8
To measure the effect of RBD1119 on blood coagulation factor XI activity.
Primary endpoint
Time frame: Week 8
Change from baseline in blood coagulation factor XI activity.
5 secondary outcomes
Secondary objective
Time frame: Up to week 44
Secondary objective
Time frame: 0 [pre-dose] to 24 hours after dosing
Secondary objective
Time frame: Up to week 44
Secondary objective
Time frame: Up to week 44
Secondary objective
Time frame: Up to week 44
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 20 Oct 2026.
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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.
Anders Gabrielsen study director
Ribocure Pharmaceuticals
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RBD1119 in people with Stable Coronary Artery Disease, run by Ribocure Pharmaceuticals AB at 16 sites in 2 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 14 inclusion and 42 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Poland, Sweden. 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 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?
Contact Rebeckha Magnusson (+46 31 72 07 800, rebeckha.magnusson@ribocure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective (time frame: Week 8). 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 20 Oct 2026.