A Phase 2 study to Evaluate the Safety, Tolerability and Efficacy of Efgartigimod PH20 SC given by prefilled syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Argenx

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

11 Dec 2024 → ongoing

Decision date (initial)

2024-10-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

argenx BV

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the safety and tolerability of efgartigimod PH20 SC in kidney transplant recipients diagnosed with antibody-mediated rejection (AMR)

Secondary objectives 4

1. To evaluate the PoC of efgartigimod PH20 SC in kidney transplant recipients diagnosed with antibody-mediated rejection (AMR)
2. Assess the PD effect of efgartigimod PH20 SC (total IgG)
3. Assess the PK profile of efgartigimod PH20 SC
4. Assess the immunogenicity of efgartigimod PH20 SC

Conditions and MedDRA coding

Antibody-Mediated Rejection

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. The participant is within the ages of 18 and 80 years old
2. The participant had a kidney transplant (living or deceased donor) at least 6 months before screening
3. The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at time of screening
4. A participant may be allowed into the study if they receive the following medications: a) Received mycophenolate mofetil (MMF) for ≥20 weeks before screening b) Has remained on a stable dose of mycophenolate mofetil (MMF) + tacrolimus (TAC) for ≥4 weeks before being allowed to participate in the study c) Has remained on tacrolimus (TAC) doses between 5 to 10 ng/mL ≥4 weeks before being allowed to participate in the study d) Steroid dose was between 0 to 10 mg per day of prednisone (or dose equivalent) for ≥4 weeks before being allowed to participate in the study

Exclusion criteria 4

1. Confirmed T-cell or mixed rejection at time of screening
2. Recent change in immunosuppressive therapy agents (more information is found in the protocol)
3. Any other medical condition that, in the investigator’s opinion, would interfere with the results of the study or put the participant at undue risk
4. Pregnant or lactating state or intention to become pregnant during the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Incidence and severity of Adverse Events (AEs)
2. Percentage of participants with permanent treatment discontinuation due to AEs
3. Laboratory assessments, vital sign measurements, and ECG

Secondary endpoints 8

1. eGFR (absolute values and changes from baseline [slope])
2. Histologic changes in kidney biopsy
3. Urine Protein Creatinine Ratio
4. Graft and participant survival
5. Percentage change from baseline in total IgG levels in serum over time
6. Efgartigimod serum concentration over time and PK parameter Ctrough
7. Incidence and prevalence of antidrug antibody(ies) (ADA) against efgartigimod in serum over time
8. Incidence and prevalence of antibodies against rHuPH20 in plasma over time

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Argenx

Sponsor organisation

Argenx

Address

Industriepark-Zwijnaarde 7

City

Gent

Postcode

9052

Country

Belgium

Scientific contact point

Organisation

Argenx

Contact name

Chief Scientific Officer

Public contact point

Organisation

Argenx

Contact name

Vice President Clinical Development

Third parties 11

Locations

6 EU/EEA countries · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 82 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications