Authorised Therapeutic exploratory (Phase II) Treatment of IgAN

A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept

EU CTIS ID: 2024-516380-81-00

What this study is testing

To evaluate the long-term safety and tolerability of atacicept.

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

1. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments.
2. Completed the protocol-defined treatment period on treatment in a parent study of atacicept in patients with IgAN.
3. For Atacicept Drug Holiday Group only: Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg at screening and Day 1.
4. A participant who was assigned female at birth is eligible if not pregnant (ie, after a confirmed menstrual period, a negative serum pregnancy test at screening and has a negative urine pregnancy test at Day 1), is not breastfeeding (for at least three months prior to screening), and at least one of the following conditions applies: *Is not a woman of childbearing potential (WOCBP) OR *Is a WOCBP who agrees to use a highly effective contraceptive method (ie, has a failure rate of less than 1% per year) at least 7 days prior to enrollment, through 175 days after the last dose of study drug.
5. For Atacicept Drug Holiday Group only: eGFR ≥ 20 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
6. For Atacicept Drug Holiday Group only: On a stable prescribed regimen of renin-angiotensin-aldosterone system inhibitor (ACEi or ARB) per guidance and local standard of care that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1.

You likely can't join if

1. For Group 1 Atacicept Drug Holiday: Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening).
10. For Group 1 Atacicept Drug Holiday: History of acute or chronic infection with human immunodeficiency virus, hepatitis C virus, or hepatitis B virus. • Participants who are positive hepatitis B surface antigen (HBsAg) are excluded • Participants who are HBsAg negative, hepatitis B core antibody (HBcAb) positive, hepatitis B surface antibody (HBsAb) positive with no detectable hepatitis B virus (HBV) DNA are eligible but will require monthly HBV DNA monitoring through safety follow up. • Participants with positive hepatitis C (HCV) RNA are excluded, however participants who are HCV antibody positive with no detectable HCV RNA at least 24 weeks after completion of antiviral therapy are eligible.
11. For Group 1 Atacicept Drug Holiday: History of splenectomy.
12. For Group 1 Atacicept Drug Holiday: History of malignancy (hematologic or solid tumor) within 5 years prior to Day 1, except adequately treated basal cell or squamous cell carcinomas of the skin (no more than 3 lesions requiring treatment in lifetime) or carcinoma in situ/cervical intraepithelial neoplasia of the uterine cervix
13. For Group 1 Atacicept Drug Holiday: Known hypersensitivity to atacicept or any component of the formulated atacicept
14. For Group 1 Atacicept Drug Holiday: Major surgery within 6 weeks prior to screening or planned/expected major surgery during the study period (including the safety follow-up period) - Major surgery often involves opening one of the major body cavities (abdomen or chest) and/or use of general anesthesia. Types of surgery that have the highest risk include heart or lung, liver, abdomen, or major operations on the bones and joints (eg, hip replacement). Participants with positive hepatitis C (HCV) RNA are excluded, however participants who are HCV antibody positive with no detectable HCV RNA at least 24 weeks after completion of antiviral therapy are eligible.

See the full eligibility criteria

Who can join

1. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments.
2. Completed the protocol-defined treatment period on treatment in a parent study of atacicept in patients with IgAN.
3. For Atacicept Drug Holiday Group only: Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg at screening and Day 1.
4. A participant who was assigned female at birth is eligible if not pregnant (ie, after a confirmed menstrual period, a negative serum pregnancy test at screening and has a negative urine pregnancy test at Day 1), is not breastfeeding (for at least three months prior to screening), and at least one of the following conditions applies: *Is not a woman of childbearing potential (WOCBP) OR *Is a WOCBP who agrees to use a highly effective contraceptive method (ie, has a failure rate of less than 1% per year) at least 7 days prior to enrollment, through 175 days after the last dose of study drug.
5. For Atacicept Drug Holiday Group only: eGFR ≥ 20 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
6. For Atacicept Drug Holiday Group only: On a stable prescribed regimen of renin-angiotensin-aldosterone system inhibitor (ACEi or ARB) per guidance and local standard of care that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1.

What rules you out

1. For Group 1 Atacicept Drug Holiday: Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening).
10. For Group 1 Atacicept Drug Holiday: History of acute or chronic infection with human immunodeficiency virus, hepatitis C virus, or hepatitis B virus. • Participants who are positive hepatitis B surface antigen (HBsAg) are excluded • Participants who are HBsAg negative, hepatitis B core antibody (HBcAb) positive, hepatitis B surface antibody (HBsAb) positive with no detectable hepatitis B virus (HBV) DNA are eligible but will require monthly HBV DNA monitoring through safety follow up. • Participants with positive hepatitis C (HCV) RNA are excluded, however participants who are HCV antibody positive with no detectable HCV RNA at least 24 weeks after completion of antiviral therapy are eligible.
11. For Group 1 Atacicept Drug Holiday: History of splenectomy.
12. For Group 1 Atacicept Drug Holiday: History of malignancy (hematologic or solid tumor) within 5 years prior to Day 1, except adequately treated basal cell or squamous cell carcinomas of the skin (no more than 3 lesions requiring treatment in lifetime) or carcinoma in situ/cervical intraepithelial neoplasia of the uterine cervix
13. For Group 1 Atacicept Drug Holiday: Known hypersensitivity to atacicept or any component of the formulated atacicept
14. For Group 1 Atacicept Drug Holiday: Major surgery within 6 weeks prior to screening or planned/expected major surgery during the study period (including the safety follow-up period) - Major surgery often involves opening one of the major body cavities (abdomen or chest) and/or use of general anesthesia. Types of surgery that have the highest risk include heart or lung, liver, abdomen, or major operations on the bones and joints (eg, hip replacement). Participants with positive hepatitis C (HCV) RNA are excluded, however participants who are HCV antibody positive with no detectable HCV RNA at least 24 weeks after completion of antiviral therapy are eligible.
15. For Group 1 Atacicept Drug Holiday: Clinically significant history of alcohol or drug abuse in the 1 year prior to Day 1 as per Investigator opinion
16. For Group 1 Atacicept Drug Holiday: Unwillingness or lack of capacity to follow all study procedures
17. For Group 1 Atacicept Drug Holiday: Treatment with other investigational agents within the last 4 weeks or 5 half-lives, whichever is longer, prior to screening
18. For Group 1 Atacicept Drug Holiday: Total urine protein excretion ≥5g per 24-hour or UPCR ≥5 mg/mg based on a 24-hour urine sample during the Screening Period
19. For Group 1 Atacicept Drug Holiday: Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening
2. For Group 1 Atacicept Drug Holiday: Evidence of nephrotic syndrome (serum albumin <30g/L in association with UPCR >3.5 mg/mg) within 6 months of screening.
20. For Group 2 Continuous Atacicept: Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of Day 1)
21. For Group 2 Continuous Atacicept: Evidence of nephrotic syndrome (serum albumin <30g/L in association with UPCR >3.5 mg/mg) within 6 months of Day 1
22. For Group 2 Continuous Atacicept: Currently on chronic dialysis, or expected to initiate dialysis within 12 weeks of Day 1
23. For Group 2 Continuous Atacicept: Renal or other organ transplantation prior to, or expected during, the study, with the exception of corneal transplants
24. For Group 2 Continuous Atacicept: Clinically significant or predefined abnormalities per central laboratory tests on Day 1 , meeting any of the criteria below: • Clinical evidence of immunosuppression and/or hypogammaglobulinemia as determined by the Investigator
25. For Group 2 Continuous Atacicept: Active clinically significant viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks prior to enrollment, or completion of oral anti-infectives within 2 weeks prior to enrollment, or a history of recurrent infections (ie, 3 or more of the same type of infection in a 12-month rolling period). Vaginal candidiasis, onychomycosis and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled are not exclusionary.
26. For Group 2 Continuous Atacicept: Known hypersensitivity to atacicept or any component of the formulated atacicept
27. For Group 2 Continuous Atacicept: Clinically significant history of alcohol or drug abuse in the one year prior to Day 1 as per Investigator opinion
28. For Group 2 Continuous Atacicept: Unwillingness or lack of capacity to follow all study procedures
3. For Group 1 Atacicept Drug Holiday: Currently on chronic dialysis, or expected to initiate dialysis within 12 weeks of screening.
4. For Group 1 Atacicept Drug Holiday: Renal or other organ transplantation prior to, or expected during, the study, with the exception of corneal transplants.
5. For Group 1 Atacicept Drug Holiday: Prohibited medications: • Use of systemic corticosteroids (including oral budesonide) or immunosuppressive medications (eg, MMF, azathioprine, cyclophosphamide, hydroxychloroquine) for the treatment of IgAN within 2 months prior to Screening • For glucocorticosteroids (GCS), “Systemic” is defined as oral, rectal or injectable (intravenous or intramuscular) routes of administration. Other routes of administration are allowed, including intra-articular, inhaled, topical, ophthalmic, optic and intranasal. • Use of B-cell–directed biologic therapies including belimumab, rituximab, ocrelizumab within 12 months of screening • Use of other biologics (eg, anti-TNF, abatacept, anti-IL-6) and investigational biologics for the treatment of IgAN within 6 months of screening
6. For Group 1 Atacicept Drug Holiday: Clinically significant or predefined abnormalities per central laboratory tests at screening, meeting any of the criteria below: - Clinical evidence of immunosuppression and/or hypogammaglobulinemia as determined by the Investigator. - Aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase level >2.5 × upper limit of normal (ULN) or total bilirubin >1.5 x ULN. *If the participant has a known history of Gilberts (history of isolated increase in total bilirubin without increase in liver transaminases), contact the Medical Monitor for further discussion.
7. For Group 1 Atacicept Drug Holiday: Administration of live and live-attenuated vaccinations within 30 days prior to enrollment
8. For Group 1 Atacicept Drug Holiday: History or current diagnosis of any demyelinating disease such as, but not restricted to, multiple sclerosis (MS) or optic neuritis (ON)
9. For Group 1 Atacicept Drug Holiday: Active clinically significant viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks prior to enrollment, or completion of oral anti-infectives within 2 weeks prior to enrollment, or a history of recurrent infections (ie, 3 or more of the same type of infection in a 12-month rolling period). Vaginal candidiasis, onychomycosis and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled are not exclusionary. • If the participant is undergoing current treatment for latent tuberculosis infection (LTBI), they must have received at least 4 continuous weeks of an appropriate LTBI treatment prior to screening without evidence of re-exposure to be eligible for this study. If on LTBI treatment at the Screening visit, the participant will be expected to complete an appropriate LTBI treatment regimen to remain in the trial. • Participants with current household contacts with active TB will be excluded unless prophylaxis treatment has been completed, and evidence that household contacts have completed treatment is provided. • Evidence of active TB determined by a local laboratory at the Screening Visit. Indeterminate local TB tests may be repeated once by the same test and will be considered positive if retest results are positive or indeterminate.

The study team makes the final eligibility decision.

Where it's taking place

Canada
United Kingdom
India
Malaysia
Turkey
Korea, Republic of
United States

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. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Canada; United Kingdom; India; Malaysia; Turkey; Korea, Republic of and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.

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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.