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Atacicept in Multiple Glomerular Diseases
EU CTIS ID: 2024-518465-10-00
What this study is testing
To evaluate the safety and tolerability of atacicept To evaluate the effect of atacicept on change from baseline in proteinuria To evaluate the PK of atacicept in children (pediatric cohorts IgAN-6, IgAN-8, and IgAN-9)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- For All Participants: On a stable prescribed regimen of RAASi for at least 8 weeks that is at the maximum labeled or tolerated dose at Screening. (pMN-1: RAASi should be initiated per standard of care prior to Screening and should remain stable for the duration of the study; NS:RAASi, SGLT2i, MRA, ERA and/or GLP-1RA are permitted provided the dosing regimen is stable for at least 8 weeks prior to Screening and should remain stable for the duration of the study)
- Systolic BP ≤160 mmHg and diastolic BP ≤90 mmHg at Screening.
- Weight ≥40 kg at Screening (Weight ≥14 kg for IgAN 9 paeditric cohorts) Enrollment for pediatric participants <40 kg will open after interim analysis of PK and safety data. Enrollment of children age ≥2 to <10 years will be deferred pending interim analysis and iDMC review.
- Willing to comply with the contraceptive guidelines of protocol
- Additional criteria apply to each cohort/disease. Pease refer to study protocol for detailed criteria.
You likely can't join if
- For All Participants: Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 12 weeks prior to and at Screening)
- Severe kidney impairment (eGFR <15 mL/min/1.73 m2) or receiving dialysis or kidney replacement therapy or other organ transplantation prior to, or expected during the study, with the exception of corneal transplants
- Mixed or multiple glomerulopathies >50% tubulointerstitial fibrosis or ≥ 25% cellular crescents on biopsy
- Active viral or bacterial infections
- Existing conditions or clinically significant laboratory abnormalities that may interfere with participation in this study
- Administration of live and live-attenuated vaccinations within 30 days prior to enrollment
See the full eligibility criteria
- For All Participants: On a stable prescribed regimen of RAASi for at least 8 weeks that is at the maximum labeled or tolerated dose at Screening. (pMN-1: RAASi should be initiated per standard of care prior to Screening and should remain stable for the duration of the study; NS:RAASi, SGLT2i, MRA, ERA and/or GLP-1RA are permitted provided the dosing regimen is stable for at least 8 weeks prior to Screening and should remain stable for the duration of the study)
- Systolic BP ≤160 mmHg and diastolic BP ≤90 mmHg at Screening.
- Weight ≥40 kg at Screening (Weight ≥14 kg for IgAN 9 paeditric cohorts) Enrollment for pediatric participants <40 kg will open after interim analysis of PK and safety data. Enrollment of children age ≥2 to <10 years will be deferred pending interim analysis and iDMC review.
- Willing to comply with the contraceptive guidelines of protocol
- Additional criteria apply to each cohort/disease. Pease refer to study protocol for detailed criteria.
- For All Participants: Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 12 weeks prior to and at Screening)
- Severe kidney impairment (eGFR <15 mL/min/1.73 m2) or receiving dialysis or kidney replacement therapy or other organ transplantation prior to, or expected during the study, with the exception of corneal transplants
- Mixed or multiple glomerulopathies >50% tubulointerstitial fibrosis or ≥ 25% cellular crescents on biopsy
- Active viral or bacterial infections
- Existing conditions or clinically significant laboratory abnormalities that may interfere with participation in this study
- Administration of live and live-attenuated vaccinations within 30 days prior to enrollment
- Known hypersensitivity to atacicept or any component of the formulated atacicept
- Concomitant or recent immunosuppression (except post-transplant IgAN cohort)
- Additional criteria apply to each cohort/disease. Pease refer to study protocol for detailed criteria.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Australia
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Australia; United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.