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CTRI Number  CTRI/2025/12/099352 [Registered on: 17/12/2025] Trial Registered Prospectively
Last Modified On: 29/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study assessing Atacicept once monthly dosing in patients with IgAN.  
Scientific Title of Study   A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients with IgAN 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
EU CT No. 2025-521519-37-00  EudraCT 
File No. CT/25/000080  DCGI 
NCT07020923 (US IND Number 122043)  ClinicalTrials.gov 
VT-001-0020 (Original Protocol dated 07-FEB-2025)  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Seth Schulman 
Designation  Lead Medical Monitor 
Affiliation  Worldwide Clinical Trials 
Address  Office No. 920, Unit No. 9, Corporate Park II, 9th floor, VN Purav Marg, Near Swastik Chambers, Chembur (E), Mumbai-400071, Maharashtra, India

Mumbai
MAHARASHTRA
400071
India 
Phone  12152069504  
Fax    
Email  seth.schulman@worldwide.com  
 
Details of Contact Person
Scientific Query  
Name  Rengadurai Ramakrishnan  
Designation  Clinical Trial Manager  
Affiliation  Worldwide Clinical Trials 
Address  Office No. 920, Unit No. 9, Corporate Park II, 9th floor, VN Purav Marg, Near Swastik Chambers, Chembur (E), Mumbai-400071, Maharashtra, India

Mumbai
MAHARASHTRA
400071
India 
Phone  6593840487  
Fax    
Email  Rengadurai.Ramakrishnan@worldwide.com  
 
Details of Contact Person
Public Query  
Name  Rengadurai Ramakrishnan  
Designation  Clinical Trial Manager  
Affiliation  Worldwide Clinical Trials 
Address  Office No. 920, Unit No. 9, Corporate Park II, 9th floor, VN Purav Marg, Near Swastik Chambers, Chembur (E), Mumbai-400071, Maharashtra, India

Mumbai
MAHARASHTRA
400071
India 
Phone  6593840487  
Fax    
Email  Rengadurai.Ramakrishnan@worldwide.com  
 
Source of Monetary or Material Support  
Vera Therapeutics, Inc 
 
Primary Sponsor  
Name  Vera Therapeutics, Inc. 
Address  2000 Sierra Point Parkway, Suite 1200,Brisbane, CA 94005,United States of America 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Ms Worldwide Clinical Trials India Private Limited  Office 920, Unit No. 9, Corporate Park II, 9th floor, VN Purav Marg, Near Swastik Chambers, Chembur, Mumbai, Maharashtra, 400071 India.  
 
Countries of Recruitment     Spain
Australia
Hungary
India
Malaysia
Philippines
Republic of Korea
Turkey
United Kingdom
United States of America
Poland  
Sites of Study  
No of Sites = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Soumita bagchi  All India Institute of Medical Sciences  Dept. of Nephrology, room no. 3101A, 3rd Floor, Teaching Block, AIIMS, Ansari nagar, New Delhi-110029
South
DELHI 		 7838063723

Soumita_bagchi@yahoo.co.in 
Dr Suceena Alexander  Christian Medical College Vellore Ranipet Campus  Department of Nephrology, Christian Medical College Vellore Ranipet Campus , Kilminnal Village, Ranipet District , Tamil Nadu 632517
Vellore
TAMIL NADU 		 917339248208

Soumita_bagchi@yahoo.co.in 
Dr Atanu Pal  IPGME&R and SSKM Hospital  244, AJC Bose Road, Kolkata-700020, West Bengal, India
Kolkata
WEST BENGAL 		 8670254077

dratanup@gmail.com 
Dr Pradeep Shenoy M  Justice K S Hegde Charitable Hospital  Justice K S Hegde Charitable Hospital, Deralakatte, Mangalore University Road, Mangalore, Karnataka-575018
Bangalore
KARNATAKA 		 9739448970

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

srnephro@gmail.com 
Dr Pinaki Mukhopadhyay  Nil Ratan Sircar Medical College & Hospital  138, AJC Bose Road, Kolkata-700014 West Bengal India
Kolkata
WEST BENGAL 		 9825905350

drpinaki71@yahoo.com 
Dr Avinash Ignatius  Noble Hospitals Pvt Ltd  Noble Hospitals Pvt. Ltd.153, Magarpatta City Road, Hadapsar, Pune-411013, Maharashtra, India
Pune
MAHARASHTRA 		 9922862468

dr_ignatius@yahoo.co.in 
Dr Srinivas K  Princess Krishnajammanni Super Speciality Hospital  Princess Krishnajammanni Super Speciality Hospital, Associated with K.R.Hospital, Mysore Medical college and Research Institute. Kumbarakoppal, Gokulam 3rd Stage, Gokulam, Mysuru, Karnataka 570016
Mysore
KARNATAKA 		 0821 2496520

srinivasknephro@gmail.com 
Dr Deepak Dewan  Regency Health Super specialty Hospital  Tedhi Pulia,Ring Road, Khurram Nagar, Lucknow-226022, Uttar Pradesh, India
Lucknow
UTTAR PRADESH 		 7398222815

drdeepakdewan01@gmail.com 
Dr Vivek Ruhela  Shri Guru Ram Rai Institute of Medical and Health Sciences and Shri Mahant Indiresh Hospital  Patel Nagar, Dehradun, 248001, Uttarakhand – India.

 		 8802459589

vivekruhela@yahoo.com 
Dr Sandeep Morkhandikar  WMFs Villoo Poonawalla Memorial Hospital  S.No. 156, Soli Poonawalla Road Pune-Solapur Road, Hadapsar, Pune Maharashtra - 411028
Pune
MAHARASHTRA 		 8446414692

sandeepmorkhandikar@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Central Ethics Committee  Approved 
Ethics Committee N.R.S Medical College  Approved 
IEC-MMC and RI and Associated Hospital  Submittted/Under Review 
Instituional Ethics Committee Welfare Medical Foundations Villoo Poonawala Memorial Hospital  Approved 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee Regency Hospital  Approved 
Institutional Ethics Committee SGRR Institute of Medical Health Sciences  Approved 
Institutional Review Board  Submittted/Under Review 
IPGME and R Research Oversight Committee  Approved 
KIMS Institutional Ethics Committee  Approved 
Noble Hospital Institutional 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  Arm 1: Atacicept 300 mg administered Q4W subcutaneous (SC) injection 
Intervention  Atacicept  Arm 2: Atacicept 450 mg administered Q4W SC injection  
Intervention  Atacicept  Arm 3: Atacicept 600 mg administered Q4W SC injection  
Intervention  Atacicept  Arm 4: Atacicept 150 mg administered QW SC injection  
Intervention  Atacicept  Arm 5: Atacicept 150 mg administered QW SC injection for the first 24 weeks, then switch to 300 mg Q4W  
Intervention  Atacicept  Participants will be randomized into 1 of 5 treatment arms in a 1:1:1:1:1 ratio to receive 300 mg, 450 mg, or 600 mg atacicept Q4W SC injection for 24 weeks, 150 mg atacicept QW SC injection for up to 48 weeks, or 150 mg atacicept QW SC injection for 24 weeks followed by 300 mg Q4W for up to 24 weeks. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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 Adult male or female of greater than or equal to 18 years of age or as per country specific legally or nationally recognized adult age who provides written informed consent prior to performing any study assessments
3 Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years of the screening visit
4 Total urine protein excretion greater than or equal to zero point 75 g per 24 hour or urine protein to creatinine ratio UPCR greater than or equal to zero point 75 mg per mg based on a 24 hour urine sample during the screening period
5 eGFR greater than or equal to 30 mL per min per 1 point 73 m2 at screening as per the Chronic Kidney Disease
Epidemiology Collaboration CKD EPI equation
6 On a stable prescribed regimen of RASi ACEi or ARB for at least 8 weeks that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1
The participant is eligible if they do not tolerate RASi provided their management of IgAN is standard of care per local practice This intolerance must be documented by the investigator and discussed with the Medical Monitor
SGLT2i MRA ERA and or GLP 1RA are permitted provided the dosing regimens is stable for at least 8 weeks prior to screening
7 Systolic blood pressure less than or equal to 160 mmHg and diastolic blood pressure less than or equal to 90 mmHg at screening
8 A female is eligible if she is not pregnant that is after a confirmed menstrual period a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1
not breastfeeding for at least 3 months prior to screening and at least one of the following conditions applies
Is not a woman of childbearing potential WOCBP as defined in Appendix 1
OR
Is a WOCBP who agrees to use a highly effective contraceptive method that is has a failure rate of less than 1 percent per year as listed in Appendix 1 at least 7 days prior to randomization through 175 days after the last dose of study drug
 
 
ExclusionCriteria 
Details  1 Participation in a study of atacicept or any previous treatment with atacicept
2 IgAN secondary to another condition eg liver cirrhosis or other causes of mesangial IgA deposition including IgA vasculitis example Henoch-Schonlein purpura systemic lupus erythematosus dermatitis herpetiformis ankylosing spondylitis
3 Evidence of rapidly progressive glomerulonephritis loss of greater than or equal to 50 Percentage of eGFR within 3 months of screen
4 Total urine protein excretion greater than or equal to 5g per 24 hours or UPCR greater than or equal to 5 mg per mg based on a 24 hour urine sample during the screening perioding
5 Evidence of nephrotic syndrome within 6 months of screening serum albumin less than 3point0 g per dL in association with UPCR greater than 3point5 mg per mg
6 Renal or other organ transplantation prior to or expected during the study, with the exception of corneal transplants
7 Concomitant chronic renal disease in addition to IgAN example diabetic nephropathy primary focal segmental glomerulosclerosis membranous nephropathy C3 glomerulopathy, lupus nephritis
8 Uncontrolled diabetes defined as hemoglobin A1c HbA1c greater than 7point5 percentage at screening
9 History of tuberculosis TB, untreated latent TB infection LTBI or evidence of active TB determined by a positive Quantiferon test at the screening visit If the participant is undergoing current treatment for LTBI they must have received at least 4 continuous weeks of an appropriate LTBI treatment prior to the screening visit without evidence of reexposure 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 study
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
Indeterminate Quantiferon tests may be repeated once by the same test and will be considered positive if retest results are positive or indeterminate
10 Use of any of the following prohibited medications
Systemic corticosteroids including oral budesonide for the treatment of IgAN within 6 months prior to screening from screening to Day 1 or expected use during the study
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 otic and intranasal
For nonIgAN indications eg gout flare exacerbation of asthma severe rash etc as follows
Within 12 weeks prior to randomization Use of systemic corticosteroids or immunosuppressive medications for greater than 1 week or average dose greater than 0point5 mg per kg per day prednisolone or equivalent Immunosuppressive medications example mycophenolate mofetil MMF, azathioprine cyclophosphamide hydroxychloroquine for the treatment of IgAN within 12 weeks prior to screening from screening to Day 1 or expected use during the study
Use of traditional Chinese medications and or Ayurvedic medications for IgAN within 12 weeks prior to screening from screening to Day 1 or during the study period
Including but not limited to Lei Gong Teng Tripterygium Wilfordii Hook F Caulis sinomenii and Sinomenium acutum Any other medications used to treat IgAN that are not listed should be discussed with the Medical Monitor
Use of B cell directed biologic therapies including but not limited to belimumab rituximab, or ocrelizumab for any period of time
Use of other biologics example anti TNF abatacept, anti IL 6 and investigational biologics for any period of time
11 Clinically significant or predefined abnormalities per central laboratory tests at the screening visit meeting any of the following criteria
Serum IgG below 7 g per L
AST ALT or ALP level greater than 2point5 × upper limit of normal ULN or total bilirubin
greater than 1point5 × 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
12 Administration of live and live attenuated vaccinations within 30 days prior to randomization
13 History or current diagnosis of any demyelinating disease such as but not restricted to multiple sclerosis or optic neuritis
14 Patients with history of unstable angina, Class III and IV congestive heart failure and or clinically significant arrhythmia as judged by the investigator
15 Any condition, including any uncontrolled disease state other than IgAN, that in theopinion of the investigator or the sponsor or designee constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives conduct or evaluation.
16 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 or during the screening visit or completion of oral anti infectives within 2 weeks prior to or during the screening visit or a history of recurrent infections example 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
17 History of acute or chronic infection with human immunodeficiency virus HIV or hepatitis B virus HBV
Positive hepatitis B surface antigen HBsAg is excluded
Participants who are HBsAg negative hepatitis B core antibody HBcAb positive hepatitis B surface antibody HBsAb positive and with no detectable HBV DNA are eligible but will require monthly HBV DNA monitoring through safety follow up
18 Participants with positive hepatitis C virus 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
19 History of splenectomy
20 History of malignancy within the past 5 years prior to screening except for adequately treated basal cell carcinoma or non metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ with no evidence of recurrence
21 Known hypersensitivity to atacicept or any component of the formulated atacicept
22 Major surgery within 6 weeks prior to the screening visit or planned or 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 chest or skull Types of surgery that have the highest risk include heart lung liver and abdomen surgeries or major operations on the bones and joints eg hip replacement
23 Clinically significant history of alcohol or drug abuse in the 1 year prior to the screening visit as per investigators opinion
24 Unwillingness or lack of capacity to follow all study procedures
25 Treatment with other investigational agents within the last 4 weeks or 5 half lives
whichever is longer prior to the screening visit
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluate the effect of atacicept on Gd-IgA1 in patients with
IgAN
 		 Week 24 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate the safety and tolerability of atacicept at different dosing regimens   
Evaluate the effect of atacicept on serum immunoglobulins
(IgA, IgG, IgM) 		 WEEK 24 
Evaluate serum PK of atacicept  End of the study 
Evaluate the immunogenicity of atacicept  End of the study 
Evaluate the effect of atacicept on change in proteinuria  End of the study 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="20" 
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   Phase 2 
Date of First Enrollment (India)   29/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  12/06/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
Atacicept is currently in Phase 3 clinical development for the treatment of IgAN and is administered 150 mg once-weekly via prefilled syringe (PFS). Because of the health-relatedquality of life and economic benefits, ongoing efforts aim to improve convenience with afocus on the frequency and ease of administration. Exploring a longer dosing interval (ie,once-monthly injection) is supported by the long half-life of atacicept.The primary objective of this Phase 2 study is to explore the dose-response relationship ofonce-monthly atacicept PFS across different dose levels (300 mg, 450 mg, and 600 mg)versus 150 mg once-weekly atacicept PFS in patients with IgAN. The safety, tolerability, andefficacy/pharmacodynamics of atacicept compared with once-weekly atacicept will also be investigated.
 
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