Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN)

Sponsor

Eledon Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05125068

Collaborator

(none)

Enrollment

Locations

Arms

40.4

Anticipated Duration (Months)

3.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of screening.

Condition or Disease	Intervention/Treatment	Phase
IgA Nephropathy IgAN	Drug: AT-1501	Phase 2

Detailed Description

Phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of Screening. Up to 42 eligible patients will receive one of 2 doses of AT-1501. All patients are scheduled to receive AT-1501 by intravenous infusion every 3 weeks for approximately 2 years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy

Actual Study Start Date :

Mar 21, 2022

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A AT-1501 10mg/kg Arm A will receive 10 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions.	Drug: AT-1501 AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Experimental: Arm B AT-1501 5mg/kg Arm B will receive 5 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions	Drug: AT-1501 AT-1501 monoclonal antibody targeting CD40L given as an IV infusion

Arm

Intervention/Treatment

Experimental: Arm A

AT-1501 10mg/kg Arm A will receive 10 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions.

Drug: AT-1501

AT-1501 monoclonal antibody targeting CD40L given as an IV infusion

Experimental: Arm B

AT-1501 5mg/kg Arm B will receive 5 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions

Drug: AT-1501

AT-1501 monoclonal antibody targeting CD40L given as an IV infusion

Outcome Measures

Primary Outcome Measures

Efficacy - change in participants UPCR [Up to 24 weeks]
The change in 24-hour urine protein to creatinine ratio (UPCR) from baseline to 24 weeks
Safety- Number of participants with treatment related adverse events [Through study completion, an average of 100 weeks]
Incidence of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs of special interest (AEoSI)

Secondary Outcome Measures

Change in eGFR slope [Baseline- 96 weeks]
The change in eGFR slope from baseline to 96 weeks
Change in urine protein excretion (mg/mg) [Up to 96 weeks]
The change in urine protein excretion over time
Development of Anti drug Antibodies (ADAs) [Up to 96 weeks]
The percentage of participants who develop ADAs

Other Outcome Measures

Exploratory- Change in baseline serum biomarkers [Through study completion, an average of 100 weeks]
The change in serum biomarkers from baseline to completion of study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female ≥ 18 years of age
Biopsy proven IgAN
Urine protein ≥ 0.75g/24 hours at Screening despite optimization with ACE inhibitors or angiotensin receptor blockers (ARB)
eGFR ≥ 45 mL/min per 1.73 m2 or eGFR < 45 mL/min per 1.73 m2 and ≥ 30 mL/min per 1.73 m2 with a kidney biopsy within 2 years of Screening showing < 50% tubulointerstitial fibrosis
Agree to comply with contraception requirements during and for 90 days after study completion.

Exclusion Criteria:

Any secondary IgAN as defined by the investigator
Patients who have undergone a kidney transplant
Any history of kidney disease other than IgAN
Any history of diabetes (Type 1 or Type 2)
Seated blood pressure > 140 mmHg (systolic) or > 90 mmHg (diastolic) at the Screening Visit. Patients must be on a stable dose and regimen of an ACE inhibitor or ARB for at least 90 days
Pregnancy or breastfeeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Liverpool Hospital	Liverpool	South Wales	Australia	NSW 2170
2	Monash Medical Centre	Clayton	Victoria	Australia	3168
3	University Malaya Medical Centre (UMMC)	Kuala Lumpur	Kuala Lumpur WP	Malaysia	59100
4	Hospital Tengku Ampuan Afzan (HTAA)	Kuantan	Pahang	Malaysia	25100
5	Hospital Serdang	Kajang,	Selangor	Malaysia	43000
6	Hospital Kajang	Kajang	Selangor	Malaysia	43000
7	Waikato Hospital	Hamilton		New Zealand	3204
8	Hawke's Bay Hospital	Hastings		New Zealand	4120
9	Hospital de Sagunto	Sagunto	Valencia	Spain
10	Hospital Clinico San Carlos	Madrid		Spain
11	Hospital Virgen de la Macarena	Sevilla		Spain