IgA NephropathyPhase 1/2NCT03945318
Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)
A Phase 1/2 study testing BION-1301 Single Dose and BION-1301 Multiple Doses in people with IgA Nephropathy, run by Novartis Pharmaceuticals at 16 sites in 3 countries.
Trial summary
Multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BION-1301 in healthy volunteers and adults with IgA Nephropathy (IgAN). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- BION-1301 Single Dose and BION-1301 Multiple Doses
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 8 Apr 2019to 10 Jun 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female volunteers, 18 to 55 years old
- Females must be of non-childbearing potential
- Males must agree to follow the protocol-specified contraception guidance
- Body mass index (BMI) between 18 and 35 kg/m^2, with a weight of at least 50 kg
- Non-smoker, defined as an individual who has not smoked previously and/or who has discontinued smoking or the use of nicotine/nicotine-containing products at least 3 months before Screening
- Able to provide signed informed consent
Show all 15Show fewer
- Male or female ≥18 years old at Screening
- Women of child-bearing potential (WOCBP; per CTFG 2014) must agree to follow the protocol-specified contraception guidance throughout the study (from Screening through approximately 6 months after the final dose of study drug)
- Males must agree to follow the protocol-specified contraception guidance throughout the study (from Screening through approximately 6 months after the final dose of study drug)
- BMI between 18 and 40 kg/m^2, inclusive, at Screening with a weight of at least 50 kg
- Diagnosis of IgAN verified by biopsy taken within the past 10 years
- Urine protein ≥ 0.5 g/24h; OR UPCR ≥ 0.5 g/g (or ≥ 50 mg/mmol)
- eGFR (per Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) or measured GFR ≥ 30 mL/min per 1.73 m^2
- Stable on an optimized dose of angiotensin converting enzyme (ACE) inhibitors and/or angiotensin-receptor blockers (ARBs) for at least 3 months prior to Screening or intolerant to ACE/ARB
- 1. Completed Part 3 of the study through Week 124 and completed of the 52-week follow-up period.
Who cannot join
- Regular consumption of alcohol within 6 months prior to Screening, or use of soft drugs (such as marijuana) within 3 months prior to Screening, or hard drugs (such as cocaine and phencyclidine) within 1 year prior to Screening and/or positive blood or urine test results for drugs of abuse or alcohol at Screening or Admission
- Donated blood in the 3 months prior to the first dose of study drug, plasma in the 7 days prior to the first dose of study drug, or platelets in the 6 weeks prior to the first dose of study drug
- History or evidence of a clinically significant disorder, condition, or disease that could pose a risk to participant safety or interfere with the study, or would make the participant unsuitable for participation, eg, respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, or psychiatric disease
- Female who is breastfeeding or who has a positive serum pregnancy test at Screening or a positive urine pregnancy test on Day -1
- Known or suspected allergy or hypersensitivity to any component of BION-1301, or history of severe hypersensitivity reaction to any monoclonal antibody
- Donated blood in the 3 months prior to the first dose of study drug; plasma in the 7 days prior to the first dose of study drug; or platelets in the 6 weeks prior to the first dose of study drug
Show all 25Show fewer
- Participated in any other study in which receipt of an investigational new drug, or investigational device occurred within 28 days, or 5 half-lives (whichever is longer) of first dose of study drug in the present study
- Secondary forms of IgAN as defined by the treating physician (eg, IgA vasculitis and those with associated alcoholic cirrhosis)
- Received systemic corticosteroid therapy (> 10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy within 3 months prior to the first dose of study drug
- PART 4 Eligibility Criteria for Re-treatment Due to Evidence of Disease Progression
- (Option 1) Inclusion Criteria for Re-treatment Due to Evidence of Disease Progression
- Completed Part 3 of the study through Week 124 and entered the 52-week follow-up period.
- UPCR ≥ 0.5 g/g AND ≥ 30% increase from EOT (Week 124). Both proteinuria criteria must be met by a 24-hour urine assessment during the 52-week follow-up period. In addition to the scheduled assessments, investigators may order periodic FMV assessments (for example monthly) to follow a participant more closely. Based on an off-schedule FMV result, or other laboratory or clinical evidence, investigators may order an off-schedule 24-urine collection to confirm disease progression.
- Exclusion Criteria for Re-treatment Due to Evidence of Disease Progression
- Based on the Investigator's judgment, the participant would not benefit from resuming treatment with BION-1301 or there is a safety concern for the individual participant which outweighs the expected benefit from resuming treatment.
- Received systemic corticosteroid therapy, including budesonide, for >14 days within 3 months prior to the first dose of Part 4 for the treatment of IgAN
- Received any other form of immunosuppressive therapy such as, but not limited to mycophenolate mofetil, azathioprine, cyclosporine, tacrolimus, rituximab, cyclophosphamide, etc) within 3 months prior to the first dose of Part 4 study drug
- Received investigational products for the treatment of IgAN, other than BIO-1301
- Received newly approved immunosuppressive or immunomodulatory therapy for the treatment of IgAN including but not limited to other anti-APRIL therapies and iptacopan
- Eligibility Criteria for Optional Re-treatment (Option 2)
- Based on the Investigator's judgment, the participant would not benefit from resuming treatment with BION-1301 or there is a safety concern for the individual participant which outweighs the expected benefit from resuming treatment.
- Received systemic corticosteroid therapy, including budesonide, for >14 days within 3 months prior to the first dose in Part 4 for the treatment of IgAN
- Received any other form of immunosuppressive therapy (such as, but not limited to mycophenolate mofetil, azathioprine, cyclosporine, tacrolimus, rituximab, cyclophosphamide, etc) within 3 months prior to the first dose of Part 4 study drug
- Received investigational products for the treatment of IgAN, other than BIO-1301
- Received newly approved immunosuppressive or immunomodulatory therapy for the treatment of IgAN including but not limited to other anti-APRIL therapies and iptacopan
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United States9 sites
Liberty Research Center
Arlington, Texas, 76012
New York Nephrology
Clifton Park, New York, 12065
Liberty Research Center
Dallas, Texas, 75230
Colorado Kidney Care, P.C.
Denver, Colorado, 80230
Prolato Clinical Research Center
Houston, Texas, 77054
Amicis Research Center
Northridge, California, 91324
Chris Sholer, P.C.
Oklahoma City, Oklahoma, 73116
Nephrology Associates of Central Florida
Orlando, Florida, 32806
Elixia Tampa, LLC
Tampa, Florida, 33618
South Korea5 sites
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 14068
Soon Chun Hyang University Hospital Cheonan
Cheonan, Chungcheongnam-do, 31151
National Health Insurance Service Ilsan Hospital
Goyang-si, Gyeonggi-do, 10444
Hanyang University Guri Hostpital
Guri-si, Gyeonggi-do, 11923
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
United Kingdom2 sites
Liverpool University Hospital NHS Foundation Trust
Liverpool, England, L7 8XP
PAREXEL Early Phase Clinical Unit
London, HA1 3UJ
About this study
Official title: A Phase 1/2, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy
Multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BION-1301 in healthy volunteers and adults with IgA Nephropathy (IgAN).
Read the detailed description
This is a Phase 1/2 study of BION-1301, a first-in-class humanized IgG4 anti-a proliferation-inducing ligand (APRIL) monoclonal antibody.
The study was conducted in four parts. Part 1: double-blind, randomized, placebo-controlled, single ascending dose (SAD) in healthy volunteers (HVs). Part 2: double-blind, randomized, placebo-controlled multiple ascending dose (MAD) in HVs. Part 3: Open-label, multiple dose (MD) in participants with IgAN. Part 4: Retreatment period
The study planned to enroll up to 40 participants with IgAN.
- Conditions
- IgA Nephropathy
- Being tested
- BION-1301 Single Dose, Placebo Single Dose, BION-1301 Multiple Doses, Placebo Multiple Doses
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BION-1301 Single DoseDrug
Also called Zigakibart, FUB523
A single IV infusion infusion of BION-1301 at doses ranging from 10 to 1350 mg, administered once
Placebo Single DoseDrug
A single IV infusion of placebo
BION-1301 Multiple DosesDrug
Also called Zigakibart, FUB523
Part 2: Multiple IV infusions of BION 1301 administered every 2 weeks (Q2W) at doses of 50 mg, 150 mg or 450 mg for up to 3 doses.
Part 3: Repeated dosing of BION 1301: 450 mg IV Q2W for ≥24 weeks followed by 600 mg SC Q2W, or 600 mg SC Q2W throughout.
Placebo Multiple DosesDrug
Multiple IV infusions of placebo administered every 2 weeks for up to 3 doses
BION-1301 Single DoseDrug
Also called Zigakibart, FUB523
600 mg SC injection every 2 weeks (Q2W) for retreatment, administered via vials or pre-filled syringes (PFS)
| Study group | Role | What they receive |
|---|---|---|
| Part 1: BION-1301 | Experimental | Up to 5 cohorts with single ascending doses of BION-1301 administered by intravenous (IV) infusion in healthy volunteers. Receives: Drug: BION-1301 Single Dose |
| Part 1: Placebo | Placebo comparator | Healthy Volunteers receive a single dose of placebo administered by IV infusion. Receives: Drug: Placebo Single Dose |
| Part 2: BION-1301 | Experimental | Up to 4 cohorts with multiple doses of BION-1301 administered by intravenous (IV) infusion in healthy volunteers. Receives: Drug: BION-1301 Multiple Doses |
| Part 2: Placebo | Placebo comparator | Healthy Volunteers receive placebo by IV infusion. Receives: Drug: Placebo Multiple Doses |
| Part 3: BION-1301 | Experimental | Two cohorts of participants with IgAN receive multiple doses of BION-1301 by IV infusion (Cohort 1) or SC injection (Cohort 2) at 600mg/biweekly. Receives: Drug: BION-1301 Multiple Doses |
| Part 4 Retreatment: BION-1301 | Experimental | Eligible participants with IgAN from Part 3 may enroll in Part 4 due to disease progression or by choice for optional retreatment and receive SC injection at 600mg/biweekly. Receives: Drug: BION-1301 Single Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment Emergent Adverse Events (TEAEs) and treatment-emergent serious adverse events (SAEs)
TEAEs and SAEs are assessed throughout each participant's study participation according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Measured: Up to 276 weeks
Change from baseline in systolic and diastolic blood pressure
Change from baseline in systolic and diastolic blood pressure
Measured: Baseline and up to 276 weeks.
Change from baseline in estimated glomerular filtration rate (eGFR)
Change from baseline in estimated glomerular filtration rate (eGFR)
Measured: Baseline and up to 276 weeks
Secondary outcomes (8)
Cmax
Maximum observed concentration
Measured: Up to Day 85
Tmax
Time corresponding to occurrence of Cmax
Measured: Up to Day 85
T½
Apparent terminal elimination half life
Measured: Up to Day 85
AUC
Area under the concentration-time curve (AUC)
Measured: Up to Day 85
Incidence of ADA and neutralizing antibodies (Nabs)
Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (Nabs)
Measured: Up to 276 weeks
Change from baseline in immunoglobulin levels
Change from baseline in immunoglobulin levels (IgA, IgG, IgM)
Measured: Baseline and up to 276 weeks
Change from baseline in UPCR
Change from baseline in urinary protein/creatinine ratio (UPCR) based on 24-hour urine collection
Measured: Up to 276 weeks
Change from baseline in urinary protein excretion
Change from baseline in urinary protein excretion based on 24-hour urine collection
Measured: Up to 276 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start8 Apr 2019
- Primary completion10 Jun 2026
- Study completion10 Jun 2026
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 IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 (SAD-HV) is a randomized, placebo-controlled single ascending dose design in HVs. Part 2 (MAD-HV): is a randomized, placebo-controlled multiple ascending dose design in HVs. Part 3 (MD-IgAN) is an open-label multiple dose design in participants with IgAN. Part 4 (IgAN) is open-label retreatment for Part 3 participants.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945318
- Sponsor's protocol ID
- CFUB523A12103
- Other IDs
- 2018-003360-31, ADU-CL-19, 2018
- Status last verified
- May 2026
- First submitted
- 21 Apr 2019
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
Publications
Kooienga L, Lo J, Lee EY, Kim SG, Thomas H, Workeneh B, Agha I, Song Y, Smith W, van Eenennaam H, Van Elsas A, Dulos J, Barratt J. Zigakibart demonstrates clinical safety and efficacy in a Phase 1/2 trial of healthy volunteers and patients with IgA nephropathy. Kidney Int. 2025 Sep;108(3):445-454. doi: 10.1016/j.kint.2025.05.006. Epub 2025 Jun 5.
PubMed 40482854
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy
- ClinicalTrials.gov ID
- NCT03945318
- Acronym / sponsor ID
- CFUB523A12103
- Conditions
- IgA Nephropathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 10 May 2019 (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.
Multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BION-1301 in healthy volunteers and adults with IgA Nephropathy (IgAN).
Detailed description
This is a Phase 1/2 study of BION-1301, a first-in-class humanized IgG4 anti-a proliferation-inducing ligand (APRIL) monoclonal antibody.
The study was conducted in four parts. Part 1: double-blind, randomized, placebo-controlled, single ascending dose (SAD) in healthy volunteers (HVs). Part 2: double-blind, randomized, placebo-controlled multiple ascending dose (MAD) in HVs. Part 3: Open-label, multiple dose (MD) in participants with IgAN. Part 4: Retreatment period
The study planned to enroll up to 40 participants with IgAN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- Model description
- Part 1 (SAD-HV) is a randomized, placebo-controlled single ascending dose design in HVs. Part 2 (MAD-HV): is a randomized, placebo-controlled multiple ascending dose design in HVs. Part 3 (MD-IgAN) is an open-label multiple dose design in participants with IgAN. Part 4 (IgAN) is open-label retreatment for Part 3 participants.
| Arm | Type | Receives |
|---|---|---|
| Part 1: BION-1301 | Experimental | Drug: BION-1301 Single DoseUp to 5 cohorts with single ascending doses of BION-1301 administered by intravenous (IV) infusion in healthy volunteers. |
| Part 1: Placebo | Placebo comparator | Drug: Placebo Single DoseHealthy Volunteers receive a single dose of placebo administered by IV infusion. |
| Part 2: BION-1301 | Experimental | Drug: BION-1301 Multiple DosesUp to 4 cohorts with multiple doses of BION-1301 administered by intravenous (IV) infusion in healthy volunteers. |
| Part 2: Placebo | Placebo comparator | Drug: Placebo Multiple DosesHealthy Volunteers receive placebo by IV infusion. |
| Part 3: BION-1301 | Experimental | Drug: BION-1301 Multiple DosesTwo cohorts of participants with IgAN receive multiple doses of BION-1301 by IV infusion (Cohort 1) or SC injection (Cohort 2) at 600mg/biweekly. |
| Part 4 Retreatment: BION-1301 | Experimental | Drug: BION-1301 Single DoseEligible participants with IgAN from Part 3 may enroll in Part 4 due to disease progression or by choice for optional retreatment and receive SC injection at 600mg/biweekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Healthy male or female volunteers, 18 to 55 years old
- Females must be of non-childbearing potential
- Males must agree to follow the protocol-specified contraception guidance
- Body mass index (BMI) between 18 and 35 kg/m^2, with a weight of at least 50 kg
- Non-smoker, defined as an individual who has not smoked previously and/or who has discontinued smoking or the use of nicotine/nicotine-containing products at least 3 months before Screening
Key exclusion criteria (25 listed)
- Regular consumption of alcohol within 6 months prior to Screening, or use of soft drugs (such as marijuana) within 3 months prior to Screening, or hard drugs (such as cocaine and phencyclidine) within 1 year prior to Screening and/or positive blood or urine test results for drugs of abuse or alcohol at Screening or Admission
- Donated blood in the 3 months prior to the first dose of study drug, plasma in the 7 days prior to the first dose of study drug, or platelets in the 6 weeks prior to the first dose of study drug
- History or evidence of a clinically significant disorder, condition, or disease that could pose a risk to participant safety or interfere with the study, or would make the participant unsuitable for participation, eg, respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, or psychiatric disease
- Female who is breastfeeding or who has a positive serum pregnancy test at Screening or a positive urine pregnancy test on Day -1
- Known or suspected allergy or hypersensitivity to any component of BION-1301, or history of severe hypersensitivity reaction to any monoclonal antibody
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 |
|---|---|---|
| BION-1301 Single DoseAlso: Zigakibart, FUB523A single IV infusion infusion of BION-1301 at doses ranging from 10 to 1350 mg, administered once | Drug | Part 1: BION-1301 |
| Placebo Single DoseA single IV infusion of placebo | Drug | Part 1: Placebo |
| BION-1301 Multiple DosesAlso: Zigakibart, FUB523Part 2: Multiple IV infusions of BION 1301 administered every 2 weeks (Q2W) at doses of 50 mg, 150 mg or 450 mg for up to 3 doses. Part 3: Repeated dosing of BION 1301: 450 mg IV Q2W for ≥24 weeks followed by 600 mg SC Q2W, or 600 mg SC Q2W throughout. | Drug | Part 2: BION-1301, Part 3: BION-1301 |
| Placebo Multiple DosesMultiple IV infusions of placebo administered every 2 weeks for up to 3 doses | Drug | Part 2: Placebo |
| BION-1301 Single DoseAlso: Zigakibart, FUB523600 mg SC injection every 2 weeks (Q2W) for retreatment, administered via vials or pre-filled syringes (PFS) | Drug | Part 4 Retreatment: BION-1301 |
Primary outcome
Number of participants with Treatment Emergent Adverse Events (TEAEs) and treatment-emergent serious adverse events (SAEs)
Time frame: Up to 276 weeks
TEAEs and SAEs are assessed throughout each participant's study participation according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Change from baseline in systolic and diastolic blood pressure
Time frame: Baseline and up to 276 weeks.
Change from baseline in systolic and diastolic blood pressure
Change from baseline in estimated glomerular filtration rate (eGFR)
Time frame: Baseline and up to 276 weeks
Change from baseline in estimated glomerular filtration rate (eGFR)
8 secondary outcomes
Cmax
Time frame: Up to Day 85
Tmax
Time frame: Up to Day 85
T½
Time frame: Up to Day 85
AUC
Time frame: Up to Day 85
Incidence of ADA and neutralizing antibodies (Nabs)
Time frame: Up to 276 weeks
Change from baseline in immunoglobulin levels
Time frame: Baseline and up to 276 weeks
Change from baseline in UPCR
Time frame: Up to 276 weeks
Change from baseline in urinary protein excretion
Time frame: Up to 276 weeks
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 16 Jun 2026.
- Derived from this study: PubMed 40482854Kooienga L, Lo J, Lee EY, Kim SG, Thomas H, Workeneh B, Agha I, Song Y, Smith W, van Eenennaam H, Van Elsas A, Dulos J, Barratt J. Zigakibart demonstrates clinical safety and efficacy in a Phase 1/2 trial of healthy volunteers and patients with IgA nephropathy. Kidney Int. 2025 Sep;108(3):445-454. doi: 10.1016/j.kint.2025.05.006. Epub 2025 Jun 5.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BION-1301 Single Dose and BION-1301 Multiple Doses in people with IgA Nephropathy, run by Novartis Pharmaceuticals at 16 sites in 3 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 15 inclusion and 25 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 16 Jun 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 United States, South Korea, United Kingdom. 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. Some participants in this study may receive a placebo. 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 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?
Number of participants with Treatment Emergent Adverse Events (TEAEs) and treatment-emergent serious adverse events (SAEs) (time frame: Up to 276 weeks). The study lists 3 primary outcomes in all. 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 NCT03945318, 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 16 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.