Anti-Glomerular Basement Membrane DiseasePhase 3GOOD-IDES-02NCT05679401
A Study With Imlifidase in Anti-GBM Disease
A Phase 3 study testing Imlifidase, Plasma exchange (PLEX) and Cyclophosphamide (CYC) in people with Anti-Glomerular Basement Membrane Disease and Anti-Glomerular Basement Membrane Antibody Disease, run by Hansa Biopharma AB at 48 sites in 13 countries.
Trial summary
An open-label, controlled, randomised, multi-centre Phase 3 trial evaluating renal function in patients with severe anti-GBM disease comparing imlifidase and standard of care (SoC) with SoC alone. All patients will remain in the trial for 24 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti-Glomerular Basement Membrane Disease, Anti-Glomerular Basement Membrane Antibody Disease, Goodpasture Syndrome
- What is being tested?
- Imlifidase, Plasma exchange (PLEX) and Cyclophosphamide (CYC)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 48 sitesin 13 countries
- Study dates
- 22 Dec 2022to 2 Feb 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anti-GBM antibodies constituting an indication for PLEX as judged by the Investigator
- Haematuria on dipstick and/or urinary sediment
- eGFR(MDRD) <20 mL/min/1.73 m^2
- Patients aged ≥18 years
- Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
Who cannot join
- Diagnosis of anti-GBM disease more than 14 days prior to randomisation
- Anuria during the last 24-hour
- Any constituent of SoC given more than 10 days prior to randomisation
- IVIg within 4 weeks before randomisation
- History or presence of any medical condition or disease which, in the opinion of the investigator, may place the patient at unacceptable risk, or jeopardise the purpose of the study
- Patients previously randomised in the study
Show all 22Show fewer
- Unsuitable to participate in the trial for any other reason in the opinion of the investigator
- Pregnancy or breast feeding
- Contraception:
- Men who are not vasectomised or abstinent or with a partner (of child-bearing potential) not willing to use one of the highly effective contraceptives listed below from screening to 6 months following discontinuation of CYC
- Men who are not willing to refrain from donating sperm from screening to 6 months following discontinuation of CYC
- Men who are not willing to use a condom during any form of sexual intercourse, regardless of a partner being of child-bearing potential from screening to 6 months following discontinuation of CYC
- Women of child-bearing potential not willing or not able to use at least one highly effective contraceptive method from screening to 12 months following discontinuation of CYC.
- In the context of this trial, a highly effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly such as:
- combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral/intravaginal/transdermal)
- progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable)
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- bilateral tubal occlusion
- vasectomised partner
- true abstinence: When this is in line with the preferred and usual lifestyle of the patient. [Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception]
- Previous imlifidase treatment or known hypersensitivity to any of the excipients
Trial locations and contacts
48 sites in 13 countries.
48 sites in 13 countries
France9 sites
CHU de Rouen, Department of Nephrology,Transplantation, and Hemodialysis
Bois-Guillaume, Normandy, 76130
CHU Bordeaux, Hôpital Pellegrin, Service nephrologie, transplantation, dialyse, aphereses
Bordeaux, New Aquitaine, 33076 cedex
CHU Grenoble Alpes - Michallon Hospital, Nephrology, Hemodialysis, Apheresis and Kidney Transplantation
Grenoble, Auvergne-Rhône-Alpes, 38043
CHU Lille. Nephrology, dialysis transplantation
Lille, Haus-de-France, 59037
University Hospital of Marseille, Nephrology - Renal transplantation service
Marseille, Bouches-du-Rhône, 13385
CHU de Nantes, Hôtel-Dieu, Le service de néphrologie et immunologie clinique
Nantes, Pays de la Loire Region, 44000
Tenon Hospital, Renal intensive care unit
Paris, Île-de-France Region, 75020
Nouvel Hôpital Civil (University Hospital of Strasbourg)
Strasbourg, Grand Est, 67091 Cedex
Hôpital Rangueil, CHU de Toulouse, Department of Nephrology and Organ transplantation
Toulouse, Occitanie, 31059
Germany7 sites
Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
Charité Department of Nephrology and Intensive Care
Berlin, 10117
Uniklinik Koeln-Klinik II fuer Innere Medizin
Cologne, North Rhine-Westphalia, 50937
Carl-Gustav-Carus University Hospital, Medizinische Klinik III, Nephrologie
Dresden, Saxony, 01307
Universitaetsklinikum Erlangen - Medizinische Klinik 4
Erlangen, 91054
University Hospital Hamburg-Eppendorf, III Department of Medicine and Nephrology
Hamburg, 20246
LMU Klinikum, Medical Clinic IV / Department of Nephrology
Munich, Bavaria, 81377
United States6 sites
John Hopkins Medical Institution
Baltimore, Maryland, 21287
Brigham and Women's Hospital
Boston, Massachusetts, 02115
UNC Kidney Center/Division of Nephrology & Hypertension
Chapel Hill, North Carolina, 27599-7155
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43201
UCLA Medical Center Plaza
Los Angeles, California, 90024
University of Minnesota Health Clinical Research Unit
Minneapolis, Minnesota, 55455
United Kingdom5 sites
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Dept. of Vasculitis
Cambridge, Cambridgeshire, CB2 0QQ
Royal Infirmary of Edinburgh, Department of Renal Medicine
Edinburgh, EH16 4SA
University College London, Royal Free Hospital, Department of Renal Medicine
London, NW3 2QG
Hammersmith Hospital, Renal medicine and centre for inflammatory diseases
London, W12 0HS
Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL
Sweden4 sites
Karolinska University Hospital
Huddinge, 14186
Linköping University Hospital
Linköping, 58185
Skåne University Hospital, Department of Nephrology
Lund, 22185
Uppsala University Hospital, Department of Medical Sciences, Renal Medicine
Uppsala, 751 85
Austria3 sites
Med Uni Graz / LKH-UNIV Klinikum Graz, Klinische Abteilung fuer Nephrologie
Graz, Stiermark, 8036
Medical University Innsbruck, Dept of Internal Medicine IV (Nephrology and Hypertension)
Innsbruck, Tyrol, 6020
Medical University of Vienna, Dept of Medicine III, Division of Nephrology and dialysis
Vienna, 1090
Denmark3 sites
Aarhus University Hospital, Renal Medicine and Clinical Medicine
Aarhus N, Central Jutland, 8200
Rigshospitalet, Department of Nephrology
Copenhagen, 2100
Odense University Hospital, Medical Nephrology, Department Y
Odense, Region Syddanmark, 5000
Italy3 sites
IRCCS S. Orsola - Malpighi University Hospital - Nephrology, Dialysis and Transplantation Unit (pav 15)
Bologna, 40138
ASST degli Spedali Civili di Brescia - SC Nefrologia
Brescia, 25123
IRCCS Policlinico San Martino University Hospital, Department of Internal Medicine, Division of Nephrology
Genova, Genova-Liguria, 16132
Netherlands3 sites
University Medical Center Groningen, Division of Nephrology
Groningen, 9713GZ
Leiden University Medical Center, Department of Nephrology
Leiden, South Holland, 2333
Radboudumc
Nijmegen, 6525 GA
Spain2 sites
University Hospital Vall d'Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Ireland1 site
Department of Renal Medicine, Cork University Hospital
Cork, T12 DC4A
About this study
Official title: A Phase 3 Open-label, Controlled, Randomised, Multi-centre Trial Comparing Imlifidase and Standard-of-care With Standard-of-care Alone in the Treatment of Severe Anti-GBM Antibody Disease (Goodpasture Disease)
An open-label, controlled, randomised, multi-centre Phase 3 trial evaluating renal function in patients with severe anti-GBM disease comparing imlifidase and standard of care (SoC) with SoC alone. All patients will remain in the trial for 24 months.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Patients will be randomised to treatment in a 1:1 ratio to either imlifidase and SoC or SoC only.
SoC consists of a combination of plasma exchange (PLEX), cyclophosphamide (CYC), and glucocorticoids. For patients randomised to the imlifidase arm the first PLEX immediately after randomisation is replaced by administration of imlifidase.
Kidney function, anti-GBM antibody levels, pulmonary symptoms, safety, pharmacokinetic/pharmacodynamic (PK/PD) and health related quality of life (HRQoL) among others, will be assessed.
- Conditions
- Anti-Glomerular Basement Membrane Disease, Anti-Glomerular Basement Membrane Antibody Disease, Goodpasture Syndrome, Good Pasture Syndrome
- Being tested
- Imlifidase, Plasma exchange (PLEX), Cyclophosphamide (CYC), Glucocorticoids
- Keywords
- Anti-GBM
- Medical subject headings
- Anti-Glomerular Basement Membrane Disease, Rapidly progressive glomerulonephritis with pulmonary hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImlifidaseDrug
Also called IdeS, HMED-IdeS
Imlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly selective towards IgG. The cleavage of IgG generates one F(ab')2- and one homodimeric Fc-fragment and efficiently neutralizes Fc-mediated activities of IgG.
Plasma exchange (PLEX)Procedure or surgery
Also called PE
PLEX removes the patient's pathogenic anti-GBM antibodies, by replacement of deficient plasma with a replacement fluid.
Cyclophosphamide (CYC)Drug
Cyclophosphamide's main mechanism of action (i.e. crosslinking of strands of DNA and RNA) results in inhibition of protein synthesis. Hence treatment prevents formation of new anti-GBM antibodies.
GlucocorticoidsDrug
Glucocorticoids inhibit the inflammation process.
| Study group | Role | What they receive |
|---|---|---|
| Imlifidase and Standard-of-Care (SoC) | Experimental | * Imlifidase is administered IV as one dose of 0.50 mg/kg over 30 minutes.
* SoC consists of a standardized combination of PLEX, CYC, and glucocorticoids. Receives: Drug: Imlifidase; Procedure: Plasma exchange (PLEX); Drug: Cyclophosphamide (CYC); Drug: Glucocorticoids |
| Standard-of-Care (SoC) | Active comparator | SoC consists of a standardized combination of PLEX, CYC, and glucocorticoids. Receives: Procedure: Plasma exchange (PLEX); Drug: Cyclophosphamide (CYC); Drug: Glucocorticoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function as evaluated by estimated glomerular filtration rate (eGFR) at 6 months
Measured: At 6 months after randomisation
Secondary outcomes (22)
Proportion of patients with functioning kidney at 6 months
Measured: At 6 months after randomisation
Time to non-toxic level of anti-GBM antibodies
Measured: During the study from screening up to 6 months
Exposure to toxic level of anti-GBM antibodies
Exposure to anti-GBM antibodies will be assessed by evaluation of the area under the anti-GBM antibody concentration versus time curve.
Measured: From randomisation up to Day 22 and to Day 29 respectively
Renal function as evaluated by eGFR at 3 months
Measured: At 3 months after randomisation
Proportion of patients with functioning kidney at 3 months,
Measured: At 3 months after randomisation
Proportion of patients experiencing end stage renal disease (ESRD) within 6 months
Measured: During the study from randomisation up to 6 months
Proportion of patients experiencing death due to anti-GBM disease within 6 months
Measured: During the study from randomisation up to 6 months
Change in urine creatinine clearance (CrCl) from randomisation to 3 and 6 months
Measured: At randomisation and at 3 and 6 months
U-albumin/creatinine ratio at 3 and 6 months (24h collection)
Measured: At screening and at 3 and 6 months
U-albumin/creatinine ratio at screening and during study (morning urine void)
Measured: During the study from screening up to 6 months
Renal function as evaluated by eGFR at screening and during study
Measured: During the study from screening up to 6 months
Number of PLEX sessions within 3 months from randomisation
Measured: During the study from randomisation up to 3 months
Number of days on dialysis within 3 and 6 months from randomisation
Measured: During the study from randomisation to 3 months and 6 months
Proportion of patients being negative during study for anti-GBM antibodies/anti-neutrophilic cytoplasmic autoantibodies (ANCA)/anti-GBM antibodies+ANCA
Measured: During the study from screening up to 6 months
Number of days with mechanical ventilation due to anti-GBM disease within 3 months from randomisation
Measured: During the study from randomisation to 3 months
Number of days at intensive care unit (ICU) and number of days in hospitalisation from randomisation to 3 months
Measured: During the study from randomisation to 3 months
Change in health related quality of life (HRQoL) from screening to 6 months
All patients will fill out the HRQoL questionnaire PROMIS-29 which is a universal rather than disease specific measure.
The PROMIS-29 measure assesses pain intensity using a single 0-10 numeric pain rating item and seven health domains using four items each: physical functioning, fatigue, pain interference, depression, anxiety, ability to participate in social roles and activities, and sleep disturbance. The score of each domain is converted into a standardized score so called T-score reported for each patient. A T-score of 50 represent a person from a reference population. A T-score higher than 50 indicates more of what is measured and a T-score less than 50 indicates less of what is measured.
Measured: At screening and at 6 months
Change in health status from screening to 6 months
All patients will fill out the EQ-5D-5L questionnarie that comprises 5 questions measuring 5 dimensions of health status (mobility, self-care, usual activities, pain/ discomfort, and anxiety/depression). Patients will be asked to select a response to each category that best describes their current health. The EQ-5D-5L also contains a visual analogue scale and the patients will be asked to rate their health on a scale of 0-100.
Measured: At screening and at 6 months
Pharmacokinetic (PK) data (Cmax) from start of treatment to Day 15
Cmax = Maximum observed plasma concentration of imlifidase following dosing.
Measured: During the study from before administration of imlifidase up to Day 15
Imlifidase pharmacodynamic (PD) profile (IgG levels in serum) from start of treatment to Day 15
Imlifidase cleaves IgG. PD of imlifidase will be assessed as IgG levels in serum. A validated electrochemiluminescence (ECL) method will be used for the analysis.
Measured: During the study from before administration of imlifidase up to Day 15
Imlifidase pharmacodynamic (PD) profile (composition of different IgG fractions) from start of treatment to Day 15
Imlifidase cleaves IgG. PD of imlifidase will be assessed using a sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) analysis to measure the composition of the following fractions of IgG: Intact IgG, single cleaved IgG (scIgG) and Fab'2 fraction.
Measured: During the study from before administration of imlifidase up to Day 15
Anti-imlifidase antibody levels from start of imlifidase treatment to 6 months
Only applicable for patients who receive imlifidase.
Measured: During the study from before administration of imlifidase up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start22 Dec 2022
- Primary completion23 Jun 2025
- Study completion2 Feb 2026
Why it stopped: Company decision, not due to any safety reason.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-Glomerular Basement Membrane DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, controlled, randomised, multi-centre trial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hansa Biopharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Operations, Study director, Hansa Biopharma AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679401
- Sponsor's protocol ID
- 21-HMedIdeS-24
- Other IDs
- 2022-500121-33-01, 1005498
- Acronym
- GOOD-IDES-02
- Status last verified
- Mar 2026
- First submitted
- 15 Dec 2022
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Open-label, Controlled, Randomised, Multi-centre Trial Comparing Imlifidase and Standard-of-care With Standard-of-care Alone in the Treatment of Severe Anti-GBM Antibody Disease (Goodpasture Disease)
- ClinicalTrials.gov ID
- NCT05679401
- Acronym / sponsor ID
- GOOD-IDES-02 / 21-HMedIdeS-24
- Conditions
- Anti-Glomerular Basement Membrane Disease, Anti-Glomerular Basement Membrane Antibody Disease, Goodpasture Syndrome, Good Pasture Syndrome
- Keywords
- Anti-GBM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision, not due to any safety reason.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hansa Biopharma ABIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 23 Jun 2025 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, controlled, randomised, multi-centre Phase 3 trial evaluating renal function in patients with severe anti-GBM disease comparing imlifidase and standard of care (SoC) with SoC alone. All patients will remain in the trial for 24 months.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Patients will be randomised to treatment in a 1:1 ratio to either imlifidase and SoC or SoC only.
SoC consists of a combination of plasma exchange (PLEX), cyclophosphamide (CYC), and glucocorticoids. For patients randomised to the imlifidase arm the first PLEX immediately after randomisation is replaced by administration of imlifidase.
Kidney function, anti-GBM antibody levels, pulmonary symptoms, safety, pharmacokinetic/pharmacodynamic (PK/PD) and health related quality of life (HRQoL) among others, will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, controlled, randomised, multi-centre trial
| Arm | Type | Receives |
|---|---|---|
| Imlifidase and Standard-of-Care (SoC) | Experimental | Drug: Imlifidase, Procedure: Plasma exchange (PLEX), Drug: Cyclophosphamide (CYC), Drug: Glucocorticoids* Imlifidase is administered IV as one dose of 0.50 mg/kg over 30 minutes. * SoC consists of a standardized combination of PLEX, CYC, and glucocorticoids. |
| Standard-of-Care (SoC) | Active comparator | Procedure: Plasma exchange (PLEX), Drug: Cyclophosphamide (CYC), Drug: GlucocorticoidsSoC consists of a standardized combination of PLEX, CYC, and glucocorticoids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Anti-GBM antibodies constituting an indication for PLEX as judged by the Investigator
- Haematuria on dipstick and/or urinary sediment
- eGFR(MDRD) <20 mL/min/1.73 m^2
- Patients aged ≥18 years
- Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
Key exclusion criteria (22 listed)
- Diagnosis of anti-GBM disease more than 14 days prior to randomisation
- Anuria during the last 24-hour
- Any constituent of SoC given more than 10 days prior to randomisation
- IVIg within 4 weeks before randomisation
- History or presence of any medical condition or disease which, in the opinion of the investigator, may place the patient at unacceptable risk, or jeopardise the purpose of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImlifidaseAlso: IdeS, HMED-IdeSImlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly selective towards IgG. The cleavage of IgG generates one F(ab')2- and one homodimeric Fc-fragment and efficiently neutralizes Fc-mediated activities of IgG. | Drug | Imlifidase and Standard-of-Care (SoC) |
| Plasma exchange (PLEX)Also: PEPLEX removes the patient's pathogenic anti-GBM antibodies, by replacement of deficient plasma with a replacement fluid. | Procedure or surgery | Imlifidase and Standard-of-Care (SoC), Standard-of-Care (SoC) |
| Cyclophosphamide (CYC)Cyclophosphamide's main mechanism of action (i.e. crosslinking of strands of DNA and RNA) results in inhibition of protein synthesis. Hence treatment prevents formation of new anti-GBM antibodies. | Drug | Imlifidase and Standard-of-Care (SoC), Standard-of-Care (SoC) |
| GlucocorticoidsGlucocorticoids inhibit the inflammation process. | Drug | Imlifidase and Standard-of-Care (SoC), Standard-of-Care (SoC) |
Primary outcome
Renal function as evaluated by estimated glomerular filtration rate (eGFR) at 6 months
Time frame: At 6 months after randomisation
22 secondary outcomes
Proportion of patients with functioning kidney at 6 months
Time frame: At 6 months after randomisation
Time to non-toxic level of anti-GBM antibodies
Time frame: During the study from screening up to 6 months
Exposure to toxic level of anti-GBM antibodies
Time frame: From randomisation up to Day 22 and to Day 29 respectively
Renal function as evaluated by eGFR at 3 months
Time frame: At 3 months after randomisation
Proportion of patients with functioning kidney at 3 months,
Time frame: At 3 months after randomisation
Proportion of patients experiencing end stage renal disease (ESRD) within 6 months
Time frame: During the study from randomisation up to 6 months
Proportion of patients experiencing death due to anti-GBM disease within 6 months
Time frame: During the study from randomisation up to 6 months
Change in urine creatinine clearance (CrCl) from randomisation to 3 and 6 months
Time frame: At randomisation and at 3 and 6 months
U-albumin/creatinine ratio at 3 and 6 months (24h collection)
Time frame: At screening and at 3 and 6 months
U-albumin/creatinine ratio at screening and during study (morning urine void)
Time frame: During the study from screening up to 6 months
Renal function as evaluated by eGFR at screening and during study
Time frame: During the study from screening up to 6 months
Number of PLEX sessions within 3 months from randomisation
Time frame: During the study from randomisation up to 3 months
Number of days on dialysis within 3 and 6 months from randomisation
Time frame: During the study from randomisation to 3 months and 6 months
Proportion of patients being negative during study for anti-GBM antibodies/anti-neutrophilic cytoplasmic autoantibodies (ANCA)/anti-GBM antibodies+ANCA
Time frame: During the study from screening up to 6 months
Number of days with mechanical ventilation due to anti-GBM disease within 3 months from randomisation
Time frame: During the study from randomisation to 3 months
Number of days at intensive care unit (ICU) and number of days in hospitalisation from randomisation to 3 months
Time frame: During the study from randomisation to 3 months
Change in health related quality of life (HRQoL) from screening to 6 months
Time frame: At screening and at 6 months
Change in health status from screening to 6 months
Time frame: At screening and at 6 months
Pharmacokinetic (PK) data (Cmax) from start of treatment to Day 15
Time frame: During the study from before administration of imlifidase up to Day 15
Imlifidase pharmacodynamic (PD) profile (IgG levels in serum) from start of treatment to Day 15
Time frame: During the study from before administration of imlifidase up to Day 15
Imlifidase pharmacodynamic (PD) profile (composition of different IgG fractions) from start of treatment to Day 15
Time frame: During the study from before administration of imlifidase up to Day 15
Anti-imlifidase antibody levels from start of imlifidase treatment to 6 months
Time frame: During the study from before administration of imlifidase up to 6 months
Results and safety
The study was stopped early (reason given: Company decision, not due to any safety reason.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Anti-Glomerular Basement Membrane Disease
RecruitingEarly Phase 1
A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.
SLE, LN
RecruitingObservational study
Anti-Glomerular Basement Membrane Disease
Anti-Glomerular Basement Membrane Disease
Active, not recruitingPhase 2
A Clinical Trial With KJ103 in Anti-GBM Disease
Anti-Glomerular Basement Membrane Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Operations study director
Hansa Biopharma AB
48 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imlifidase, Plasma exchange (PLEX) and Cyclophosphamide (CYC) in people with Anti-Glomerular Basement Membrane Disease and Anti-Glomerular Basement Membrane Antibody Disease, run by Hansa Biopharma AB at 48 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in France, Germany, United States, United Kingdom, Sweden and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company decision, not due to any safety reason.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function as evaluated by estimated glomerular filtration rate (eGFR) at 6 months (time frame: At 6 months after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.