AzTrials
AzTrials

Systemic Lupus ErythematosusPhase 1/2NCT06570434

Phase 1b/2a in SLE With Budoputug

A Phase 1/2 study testing budoprutug in people with Systemic Lupus Erythematosus and SLE, run by Tenet Medicines.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of budoprutug in participants with SLE Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus, SLE, B Cells
What is being tested?
budoprutug
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2025to Apr 2027
Phase
Phase 1/2
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of SLE fulfilling SLICC criteria or 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria at least 24 weeks prior to study entry, with one of the following at Screening
  • If taking a corticosteroid regimen prior to Screening, currently receiving ≤ 20 mg prednisone or equivalent by Day -28. Exceptions for patients with active LN are detailed in Section XX (where we talk about CS use).
  • Female participants of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 1 year, with follicle-stimulating hormone in the postmenopausal range at Screening, as per central laboratory reference range.
  • Additional criteria for Phase 2a participants only:
  • Hybrid SLEDAI ≥ 6 at Screening AND Day 1. Note: only the clinical aspects of hybrid SLEDAI must be confirmed on Day 1; laboratory values that contribute to hybrid SLEDAI do not need to be re-measured prior to dosing on Day 1. Additional criteria for contributions to hybrid SLEDAI are as follows:
  • Participants with neurological system contribution to hybrid SLEDAI will not be enrolled.
Show all 12Show fewer
  • At least 6 points from the hybrid SLEDAI score must be derived from organ system involvement excluding points from oral ulcers, alopecia, or anti-dsDNA auto-antibododies
  • Additional criteria for Phase 2a participants with LN:
  • Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV LN as evidenced by renal biopsy performed within 2 years prior to or during Screening, either with or without the presence of Class V LN.
  • Proteinuria (UPCR > 1.0 gram per gram [g/g]), based on a sample from a 24 hour urine collection during Screening.
  • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
  • Currently receiving 1 or more immunosuppressive agents that has been stable for dose and route of administration for ≥ 8 weeks prior to baseline.

Who cannot join

  • Use of IV, intramuscular, intra-articular, or high-potency intralesional corticosteroids within 6 weeks prior to Screening or expectation of requiring parenteral corticosteroids during the study. Exceptions include protocol required pre-medication prior to infusion of budoprutug.
  • Use of high-potency topical corticosteroid and/or topical agents (immunosuppressant) for skin lesions within 7 days prior to Screening
  • The following laboratory values:
  • Absolute neutrophil count < 1.0 × 109/L.
  • White blood cell count < 2.0 × 109/L.
  • Cluster of differentiation (CD) 19 B-cell count <80 cells/µL.
Show all 12Show fewer
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2 × ULN.
  • Total bilirubin > 1.5 × ULN, unless due to Gilbert's syndrome.
  • History of serious or significant infusion reaction associated with rituximab, belimumab, anifrolumab, or other monoclonal antibody therapy.
  • History of or current diagnosis of active tuberculosis, untreated latent tuberculosis infection (LTBI) or undergoing current treatment for untreated LTBI
  • History of chronic (i.e., chronic urinary tract infection), recurrent (3 or more of the same type of infection in a 52-week period), latent, or recent serious infection
  • Any previous use of CD19 targeted therapy (e.g., inebilizumab or cell therapy).

About this study

Official title: A Phase 1b/2a Open Label Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Budoprutug in Adult Participants With Sys-temic Lupus Erythematosus (SLE)

The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of budoprutug in participants with SLE

Read the detailed description

This is a Phase 1b/2a, multicenter, open-label study designed to evaluate the safety, tolerability, PK, and PD of budoprutug in adult participants with SLE.

In Phase 1b, participants who fulfill the 2012 Systemic Lupus International Collaborating Clinics(SLICC) classification criteria for SLE, and who have active SLE (as defined by a SLEDAI ≥ 4 at Screening and Day 1),have failed at least 1 line of treatment, and who are assessed as appropriate for the study by the Eligibility Adjudicator, will be enrolled in sequential escalating dose cohorts. Three dose cohorts are planned.

The Phase 2a expansion cohort will include approximately 16 to 20 participants with active SLE, at least one-half of whom will have renal involvement. Participants will continue to be followed through Week 52 for safety, PK, and PD assessmentsParticipants will also be monitored during this time for ongoing clinical response, safety parameters, and kinetics of re-population of B-cell subsets after the return of B cells to baseline values.

Being tested
budoprutug
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • budoprutugDrug

    monoclonal antibody

Study groups in NCT06570434
Study groupRoleWhat they receive
Dose 1ExperimentalLow dose
Receives: Drug: budoprutug
Dose 2ExperimentalMiddle dose
Receives: Drug: budoprutug
Dose 3ExperimentalHigh Dose
Receives: Drug: budoprutug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)

    Safety assessments of budoprutug include changes in vital signs, clinical findings on physicial exam, electrocardiogram and clinical laboratory findings

    Measured: Day 1 through Week 24

Secondary outcomes (9)

  1. PK parameters

    Area under the maximum observed concentration (AUC)

    Measured: Day 1 through Week 24

  2. PK parameters

    Peak concentration (Cmax)

    Measured: Day 1 through Week 24

  3. PK parameters

    Time to maximum observed concentration(T-max)

    Measured: Day 1 through Week 24

  4. PK parameters

    Terminal half-life

    Measured: Day 1 through Week 24

  5. PK parameters

    Apparent clearance

    Measured: Day 1 through Week 24

  6. PK parameters

    Volume of distribution

    Measured: Day 1 through Week 24

  7. Immunogenicity

    Incidence of anti-drug antibodies (ADA)

    Measured: Day 1 through Week 24

  8. Immunogenicity

    Time-course of anti-drug antibodies (ADA)

    Measured: Day 1 through Week 24

  9. Immunogenicity

    Titers of anti-drug antibodies (ADA)

    Measured: Day 1 through Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study startJan 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Why it stopped: Study was never initiated

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06570434
Sponsor's protocol ID
ELM-119-001
Status last verified
Oct 2024
First submitted
19 Aug 2024
Last updated
16 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing budoprutug in people with Systemic Lupus Erythematosus and SLE, run by Tenet Medicines.

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 12 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: withdrawn, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) (time frame: Day 1 through Week 24). 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 NCT06570434.

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 16 Oct 2024; AzTrials last refreshed its copy on 29 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in