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CTRI Number  CTRI/2025/05/086952 [Registered on: 14/05/2025] Trial Registered Prospectively
Last Modified On: 27/05/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Phase 2, multicenter, rollover study to evaluate long-term safety and tolerability for atacicept in participants with IgAN who completed the protocol-defined treatment period of a Vera-sponsored study (parent study). 
Scientific Title of Study   A Multicenter, Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
2024-516380-81-00  EudraCT 
Protocol Original (15July24) DCGI approved on 7Apr25   DCGI 
VT-001-0051 - Version Original dated 15July2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suceena Alexander 
Designation  Head of Unit (Nephrology Department) 
Affiliation  Institute 
Address  Christian Medical College Vellore Ranipet Campus Department of Nephrology Kilminnal Village Ranipet District Tamil Nadu India

Vellore
TAMIL NADU
632517
India 
Phone  02241283900  
Fax    
Email  suceena@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Supriya Parui 
Designation  Regulatory Submission Coordinator  
Affiliation  Medpace Clinical Research India Pvt. Ltd 
Address  Unit Number 1203 12th Floor Bldg.Q2 Aurum Q2 Parc Gen 4-1 TTC Thane Belapur Road Navi Mumbai

Thane
MAHARASHTRA
400710
India 
Phone  9773922367  
Fax  02241270900  
Email  s.parui@medpace.com  
 
Details of Contact Person
Public Query  
Name  Supriya Parui 
Designation  Regulatory Submission Coordinator  
Affiliation  Medpace Clinical Research India Pvt. Ltd 
Address  Unit Number 1203 12th Floor Bldg.Q2 Aurum Q2 Parc Gen 4-1 TTC Thane Belapur Road Navi Mumbai

Thane
MAHARASHTRA
400710
India 
Phone  9773922367  
Fax  02241270900  
Email  s.parui@medpace.com  
 
Source of Monetary or Material Support  
Vera Therapeutics, Inc.  
 
Primary Sponsor  
Name  Vera Therapeutics, Inc.  
Address  8000 Marina Boulevard Suite 120 Brisbane CA 94005 United States of America  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Medpace Clinical Research India Pvt Ltd  Unit number 1203, 12th Floor, Bldg.Q2, Aurum Q Parc, Gen 4/1, TTC, Thane Belapur Road, Navi Mumbai - 400710 Maharashtra, India  
 
Countries of Recruitment     Republic of Korea
Belgium
Canada
Czech Republic
Germany
Greece
India
Malaysia
Poland
Turkey
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Soumita Bagchi  All India Institute of Medical Sciences, New Delhi    Department of Nephrology East Ansari Nagar, New Delhi-110029, India
New Delhi
DELHI 		 98471911744

soumita_bagchi@yahoo.co.in 
Dr Alok Jain  Apex Hospitals Pvt Ltd    sp 4 & 6 MIA Near Apex circle Jaipur 302017 India
Jaipur
RAJASTHAN 		 9829696995

drjainalok@gmail.com 
Dr Suceena Alexander  Christian Medical College  Department of Nephrology Kilminnal Village Ranipet District Tamil Nadu-632517
Vellore
TAMIL NADU 		 9894519136

suceena@gmail.com 
Dr Atanu Pal  Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital  244 AJC Bose Road Kolkata-700020 West Bengal India
Kolkata
WEST BENGAL 		 9038080051

dratanup@gmail.com 
Dr Pradeep Shenoy  Justice K S Hegde Charitable Hospital, K S Hegde Medical Academy,  A constituent unit of Nitte Deemed to be University having address at P.O, Deralakatte, Mangalore-575018, Karnataka, India
Dakshina Kannada
KARNATAKA 		 9844546066

pshenoynephro@gmail.com 
Dr Sunil R  Kempegowda Institute of Medical Sciences Hospital and Research Centre  K R Road V V Puram Bangalore 560004 India
Bangalore
KARNATAKA 		 9986633848

drsunilrg@gmail.com 
Dr Prakash Khetan  KIMS Kingsway hospital  44 Kingsway Hospital Near Kasturchand Park Nagpur- 440001 Maharashtra India
Nagpur
MAHARASHTRA 		 9823071748

prakash.khetan@kingswayhospitals.com 
Dr Pinaki Mukhopadhyay  Nil Ratan Sircar Medical college and hospital  Department of Nephrology,138, Acharya Jagadish Chandra Bose Rd, Sealdah, Raja Bazar, Kolkata, West Bengal 700014
Kolkata
WEST BENGAL 		 9231978078

drpinaki71@yahoo.com 
Dr Srinivas K  Princess Krishnajammanni Super Speciality Hospital associated with K R Hospital  Mysore Medical College and Research Institute KRS Road, Kumbarakoppal, Metagalli, Mysuru, Karnataka- 570003
Mysore
KARNATAKA 		 9740074030

srinivasnephro@gmail.com 
Dr Deepak dewan  Regency Health Super-Specialty Hospital  Ring Road, Tedhi Pulia, Khurram Nagar,Lucknow-226022, Uttar Pradesh, India
Lucknow
UTTAR PRADESH 		 9936507362

drdeepakdewan@rediffmail.com 
Dr Vivek Ruhela  Shri Mahant Indiresh Hospital  South Block, 3rd floor, Patel Nagar, Dehradun, Uttarakhand – 248001, India
Dehradun
UTTARANCHAL 		 9721104868

vivekruhela@yahoo.com 
Dr Sonal Dalal  Sterling Hospital  A unit of Sterling Addlife India Pvt. Ltd., Sterling Hospital Road, Memnagar – 380 052,
Ahmadabad
GUJARAT 		 9825008924

sonalsanjiv@gmail.com 
Dr Sandeep Morkhandikar  WMF’s Villoo Poonawalla Memorial Hospital  S.No 156, Soli Poonawalla Road,Pune Solapur Road, Hadapsar, Pune, Maharashtra – 411028, India
Pune
MAHARASHTRA 		 9823881447

sandeep.morkhandikar@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences  Approved 
Central Ethics Committee   Approved 
IEC-MMC and RI and Associated Hospital  Approved 
Institutional Ethics Committee Regency Hospital  Approved 
Institutional Ethics Committee, Apex Hospitals Private Limited  Approved 
Institutional Ethics Committee, Nil Ratan Sircar Medical College and Hospital  Approved 
Institutional Ethics Committee, Shri Guru Ram Rai Institute of Medical & Health Sciences, Shri Mahant Indiresh Hospital  Approved 
Institutional Ethics Committee, WMF’s Villoo Poonawalla Memorial Hospital  Approved 
Institutional Review Board, Christian Medical College  Approved 
IPGME and R Research Oversight Committee Institute of Postgraduate Medical Education and Research  Approved 
KIMS Institutional Ethics Committee, Kempegowda Institute of Medical Sciences  Approved 
Kingsway Hospitals Ethics Committee, Kingsway Hospitals  Approved 
Sterling Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Atacicept   Atacicept 150mg will be administered as once weekly subcutaneous (SC) injections to IgAN participants over the course of 156 weeks. Participants will be grouped by whether they are restarting atacicept after cessation in the parent study (Group 1: Atacicept Drug Holiday) or are continuing atacicept with no disruption in treatment (Group 2: Continuous Atacicept Treatment)  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Group 1 :Atacicept Drug Holiday
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. 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.  
 
ExclusionCriteria 
Details  1. Evidence of rapidly progressive glomerulonephritis-loss of greater than or equal to 50% of eGFR within 3 months of screening.
2. Evidence of nephrotic syndrome-serum albumin less than 30g/L in association with UPCR greater than 3.5 mg/mg
within 6 months of screening.
3. Currently on chronic dialysis or expected to initiate dialysis within 12 weeks of screening.
4. Renal or other organ transplantation prior to, or expected during, the study, with the exception of corneal transplants.
5. For Atacicept Drug Holiday Group only
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, 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. 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.
- For Atacicept Drug Holiday Group only: Aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase level greater than 2.5 × upper limit of normal ULN or total bilirubin greater than 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 Atacicept Drug Holiday Group only: Administration of live and live-attenuated vaccinations within 30 days prior to enrollment.
8. For Atacicept Drug Holiday Group only: History or current diagnosis of any demyelinating disease such as, but not restricted to, multiple sclerosis or optic neuritis.
9. 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, ora 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.
- For Atacicept Drug Holiday Group only: If the participant is undergoing current treatment for latent tuberculosis infection, 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.
10. For Atacicept Drug Holiday Group only: 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 Atacicept Drug Holiday Group only: History of splenectomy.
12. For Atacicept Drug Holiday Group only: 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 or cervical intraepithelial neoplasia of the uterine cervix.
13. Known hypersensitivity to atacicept or any component of the formulated atacicept.
14. For Atacicept Drug Holiday Group only: 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.
15. Clinically significant history of alcohol or drug abuse in the 1 year prior to Day 1 as per Investigator opinion.
16. Unwillingness or lack of capacity to follow all study procedures.
17. For Atacicept Drug Holiday Group only: Treatment with other investigational agents within the last 4 weeks or 5 half-lives, whichever is longer, prior to screening. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Objective: To evaluate the long-term safety and tolerability of atacicept in participants who have completed the protocol-defined treatment period in a parent study
Endpoint: Long-term safety and tolerability of atacicept as assessed by routine clinical and laboratory tests and adverse events 		 Baseline until end of study up to week156 
 
Secondary Outcome  
Outcome  TimePoints 
Objective:
To evaluate the effect of atacicept on change in proteinuria
To evaluate the effect of atacicept on the change in estimated glomerular filtration rate (eGFR) using serum creatinine and cystatin C, respectively
To evaluate the effect of atacicept on hematuria
To evaluate the effect of atacicept on serum galactose-deficient IgA1 (Gd-IgA1) levels

Endpoints:
The effect of atacicept on the following:
Changes in proteinuria based on UPCR and UACR on spot urine.
Changes in estimated glomerular filtration rate (eGFR) based on serum creatinine and cystatain C, respectively.
Hematuria level based on blood on urine dipstick.
Changes in serum Gd-IgA1 levels.  		 156 weeks  
 
Target Sample Size   Total Sample Size="476"
Sample Size from India="18" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  03/12/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Phase 2, multicenter, rollover study to evaluate long-term safety and tolerability for atacicept in participants with IgAN who completed the protocol-defined treatment period of a Vera-sponsored study (parent study). Eligible participants will receive atacicept 150 mg once weekly (QW) self-administered subcutaneously (SC). Participants will be grouped by whether they are restarting atacicept after cessation in the parent study (Group 1: Atacicept Drug Holiday) or are continuing atacicept with no disruption in treatment (Group 2: Continuous Atacicept Treatment). First dose is defined as Day 1 and should not occur prior to the completed protocol-defined treatment periods in the parent study.
Atacicept is capable of binding to all known conformations of BLyS and APRIL and is thus expected to inhibit the maturation, differentiation, and effector function of B cells. These mechanisms are consistent with the known pharmacological effects of atacicept, which include depletion of peripheral B cell subsets, naïve follicular, marginal zone and long lived plasma cell B cell subsets, impeded germinal center reaction, and reduced immunoglobulins, while leaving immature B cells and memory B cells intact (Dillon 2006, Dillon 2010, Gross 2001, Moore 1999, Schneider 1999, Schneider 2005). These effects are predicted to reduce the production and subsequent deposition of Gd-IgA1-containing immune complexes in kidney glomeruli, and thus reduce the extent of kidney injury in IgAN patients.

This study is intended to provide patients with extended and continuous access to atacicept before commercial availability in their country/region. Participants will be treated in this study for up to 3 years but could end treatment in this study once atacicept is commercially available in their country/region or if the Sponsor terminates the clinical development program. Participants who discontinue study drug early (prior to the reasons provided above) will complete an Early Termination (ET) visit.
 
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