Phase 2b/3 Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bluejay Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

26 Feb 2026 → ongoing

Decision date (initial)

2026-02-07

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety, Others

To evaluate the efficacy of switching from bulevirtide to treatment with brelovitug on CHD at Week 24

Secondary objectives 3

1. To evaluate the safety and tolerability of switching from bulevirtide to treatment with brelovitug
2. To characterize the efficacy of switching from bulevirtide to treatment with brelovitug
3. To evaluate the HDV clearance rates after treatment in participants who do not rollover to the extended treatment protocol

Conditions and MedDRA coding

Chronic Hepatitis D Infection

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. Willing and able to provide written informed consent.
2. 2. Male or female, ≥18 years of age at Screening.
3. 3. Taking or willing to take TDF, TAF, or ETV at baseline, and willing to remain on stable treatment for the duration of the study.
4. 4. Currently taking bulevirtide treatment for CHD for ≥ 6 months at the time of Screening.
5. 5. HDV RNA ≥ 100 IU/mL at Screening

Exclusion criteria 17

1. 1. Pregnant or nursing females
2. 2. Male or female participants of childbearing potential unwilling to comply with contraception requirements during the study (Appendix 4).
3. 3. Current, prior history, or is under evaluation for any of the following: a) Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy. b) Clinical hepatic decompensation (i.e., ascites, encephalopathy, variceal hemorrhage). Incidental small ascites on imaging without other clinical symptoms/signs of acute decompensation would not exclude the participants. Prior history of hepatic decompensation may be allowed if the event occurred ≥12 months from screening. c) HCC or suspicion of HCC on ultrasound at Screening d) Vasculitis
4. 3. e) Extrahepatic disorders possibly related to HBV immune complexes (e.g., glomerulonephritis, polyarteritis nodosa) f) Solid organ or bone marrow transplantation. g) Significant pulmonary disease (e.g., O2-dependent or FEV1 ≤50% predicted value) h) Significant cardiac disease (e.g., history of myocardial infarctions within 6 months, any history of ventricular tachycardia, congestive heart failure, dilated cardiomyopathy with left ventricular ejection fraction <40%) i) Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated before screening; breast cancer or prostate cancer on anti-hormonal therapy).
5. 4. CTP >6 (B or C) (see Section 6.7.7.2)
6. 5. Presence of other liver disease(s) (non-HBV/HDV), such as metabolic dysfunction associated steatohepatitis (MASH), alcohol associated hepatitis, cholestatic liver disease, other viral (e.g., HCV or HAV) or non-viral hepatitis that has the potential to impact interpretation of data. Exceptions to this criterion include fatty liver without any signs of steatohepatitis or past HCV infection that was successfully treated (HCV RNA negative) ≥6 months before screening.
7. 6. Uncontrolled HIV infection defined as having quantifiable HIV RNA levels in the blood at Screening
8. 7. History of hypersensitivity to any of the components in the brelovitug formulation
9. 8. Screening laboratory results as follows, or any other clinically significant abnormalities in Screening laboratory values that would render a participant unsuitable for inclusion: a) Platelet count <50,000/mm3 b) Hemoglobin <10.0 g/dL c) Creatinine clearance by Cockcroft-Gault (CrCl) <50 mL/min d) Alpha fetoprotein (AFP) >100 ng/mL
10. 9. Treatment with an investigational drug, a biological agent, or device within 4 weeks or 5 half-lives, whichever is longer, of baseline.
11. 10. Treatment with any interferon within 12 weeks of screening
12. 11. History or suspected non-compliance with bulevirtide treatment as evaluated by the Investigator.
13. 12. Use of any prohibited concomitant medications as described in Section 7.8
14. 13. Regular alcohol misuse, defined as weekly intake of ≥14 drinks per week (average of ≥2 drinks per day) within 12 months of Screening
15. 14. Clinically relevant drug abuse (not including cannabis) within 12 months of Screening
16. 15. Unwillingness to comply with study procedures as specified by this protocol, or unwillingness to cooperate fully with the Investigator
17. 16. Have any other conditions (medical, social, psychiatric, or other), which in the opinion of the Investigator would make the participant unsuitable for inclusion, or could interfere with the participant participating in or completing the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The proportion of participants who achieve: • Undetectable HDV RNA (< LLOQ, target not detected [TND])

Secondary endpoints 4

1. Safety endpoints will evaluate: • Incidence and severity of treatment-emergent adverse events (TEAE) • Proportion of participants who permanently discontinue treatment due to an adverse event • Change from baseline of serum total bile salts Comparison with bulevirtide will include data through 24 weeks.
2. The proportion of participants who achieve the following at Weeks 24, 48, 72, and 96 of treatment unless otherwise specified: • Virologic response defined as HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA < LLOQ, TND • HDV RNA < LLOQ • HDV RNA < LLOQ, TND (Weeks 48, 72, and 96)
3. • Normal ALT alone and in combination with: − Virologic response defined as HDV RNA ≥ 2 log10 IU/mL decline from baseline or HDV RNA < LLOQ, TND − HDV RNA < LLOQ − HDV RNA < LLOQ, TND • Change from baseline of HDV RNA • Change from baseline of ALT Comparison with bulevirtide will include data through 24 weeks
4. • Proportion of participants who achieve HDV RNA < LLOQ, TND at post-treatment follow-up Weeks 24 and 48

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bluejay Therapeutics Inc.

Sponsor organisation

Bluejay Therapeutics Inc.

Address

255 Shoreline Drive Suite 450

City

Redwood City

Postcode

94065-1450

Country

United States

Scientific contact point

Organisation

Bluejay Therapeutics Inc.

Contact name

Nancy Schulman

Public contact point

Organisation

Bluejay Therapeutics Inc.

Contact name

Nancy Schulman

Third parties 9

Locations

7 EU/EEA countries · 41 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 64 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications