Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of RBD1016 in Participants With Chronic Hepatitis D

NCT06649266 | Active Not Recruiting Phase 2

• 1 other identifier: RC04T001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to learn if drug RBD1016 works to treat chronic hepatitis D virus infection in adults. It will also learn about the safety of drug RBD1016. The main questions it aims to answer are: Does drug RBD106 reduce the HDV RNA levels? What medical problems may participants experience when taking drug RBD1016? Researchers will compare drug RBD1016 to a placebo to see if drug RBD1016 works to treat chronic hepatitis D. Participants will: Receive drug RBD1016 or a placebo several times throughout the trial. Visit the clinic once every 4-6 weeks for checkups and tests.

Conditions

Chronic Hepatitis D

Outcome Measures

Primary Outcomes (1)

• Mean change (log10 value) vs. baseline in HDV RNA levels in plasma at end of trial (Week 60).

  60 weeks

Secondary Outcomes (9)

• Frequency, intensity and seriousness of reported AEs, SAEs and AEs of special interest (AESIs) during the trial.

  60 weeks

• Mean change (log10 value) in HBsAg levels vs. baseline, at end of trial (Week 60).

  60 weeks

• Proportion of participants with positive immunogenicity, measured as plasma concentrations of anti-drug antibodies (ADAs), at each evaluation time point up to end of the study at week 60.

  60 weeks

• Mean maximum change (log10 value) in HDV RNA levels in plasma vs. baseline, at any timepoint during the study, and up to the end of study at Week 60.

  Up to 60 weeks

• Mean maximum change (log10 value) in HBsAg levels vs. baseline, at any timepoint during the study, and up to end of study at Week 60.

  Up to 60 weeks

Other Outcomes (3)

• Frequency, intensity and seriousness of reported AEs, SAEs and AEs of special interest

  Week 60 to week 108

• Dynamic changes based on local lab measurements, of HDV RNA, HBsAg, HBsAb-status and HBV DNA levels

  at each evaluation time point of the extension part of the trial up to end of trial extension (Week 108

• Proportion of participants with undetectable HDV RNA (i.e, < limit of detection based on local lab measurement)

  at any evaluation time point of the extension part of the trial.

Study Arms (2)

Active group

EXPERIMENTAL

Participants will receive RBD1016 (subcutaneous injections).

Drug: RBD1016

Deferred active group

OTHER

Participants will receive 4 doses of placebo (subcutaneous injections) followed by RBD1016 (subcutaneous injections).

Drug: RBD1016; Drug: Placebo

Interventions

RBD1016 DRUG

RBD1016, active drug.

Active group; Deferred active group

Placebo DRUG

Placebo that is identical in appearance and volume to the doses of active IMP.

Deferred active group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give written informed consent for participation in the trial.
• Male or female participant aged 18 to 65 years, inclusive.
• Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2 at the time of the screening visit.
• Documented evidence of HDV infection in medical history, i.e., HDV antibodies (HDVAb) and/or HDV RNA positive test results within at least 6 months prior to screening.
• Documented evidence of HBV infection in medical history, i.e., HBsAg and/or HBV DNA positive test results within at least 6 months prior to screening.
• Documented absence of liver cirrhosis, defined as an LSM ≥ 10 kPa measured on FibroScan® elastography at screening.

You may not qualify if:

• Laboratory results at screening as follows, or any clinically significant laboratory parameter outliers that may interfere with the evaluation of efficacy and/or safety in the trial, at the discretion of the Investigator:
• α-fetoprotein (AFP) \&amp;amp;gt; 50 µg/L.
• Albumin concentration \&amp;amp;lt; 3.0 g/dL.
• International normalized ratio (INR) \&amp;amp;gt; 1.5.
• Platelet count \&amp;amp;lt; 90 × 109/L.
• Direct bilirubin \&amp;amp;gt; 2 × ULN, Gilbert syndrome excluded.
• Creatinine concentration \&amp;amp;gt; 1.5 × ULN.
• Creatinine clearance \&amp;amp;lt; 60 mL/min, according to the Cockcroft-Gault equation.
• Positive result at screening for hepatitis C virus (HCV) and/or human immunodeficiency virus (HIV) and/or prior diagnosis of syphilis, acute hepatitis A and/or acute hepatitis E.
• Prior diagnosis of other liver diseases of non-HBV or non-HDV aetiology, including autoimmune liver disease (e.g., autoimmune hepatitis, primary biliary cholangitis or primary sclerosing cholangitis), inherited metabolic liver disease (e.g., haemochromatosis, Wilson's disease, familial intrahepatic cholestasis), drug-induced liver disease and/or non alcoholic steatohepatitis (NASH) assessed as moderate or above, at the discretion of the Investigator.
• Prior or current diagnosis of liver cirrhosis.
• History of or active hepatic decompensation, e.g., ascites, variceal bleeding or hepatic encephalopathy, at the discretion of the Investigator.
• History of organ transplantation, previous or concurrent HCC or imaging finding suggesting malignant liver lesions, at the discretion of the Investigator.
• Signs of liver malignancy in abdominal ultrasound at screening.

Sponsors & Collaborators

• Ribocure Pharmaceuticals AB: lead

Study Sites (2)

Medicinsk enhet för Infektionssjukdomar, Karolinska Universitetssjukhuset Huddinge

Stockholm, 14186, Sweden

Location

Infektionskliniken, Danderyds sjukhus

Stockholm, 18288, Sweden

Location

MeSH Terms

Conditions

Hepatitis D, Chronic

Condition Hierarchy (Ancestors)

Hepatitis D; Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: First part of the trial: All participants will be blinded to the trial treatment for the first 16 weeks after the first dose. Then, investigators and other clinic staff will be unblinded, i.e., they will know which treatment the participants receive at all times. Open-label extension part: additionally 3 doses of active IMP administered 12 weeks apart (site 01 only).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Partly blinded, placebo-controlled clinical trial with an active and a deferred active group.

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: October 18, 2024
• Study Start: August 21, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

SE (2)