Imlifidase for Goodpasture Syndrome

(GOOD-IDES-02 Trial)

Not currently recruiting at 50 trial locations

Overseen By Central Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hansa Biopharma AB

Must not be taking: IVIg

Disqualifiers: Pregnancy, Breastfeeding, Anuria, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new treatment, imlifidase, for individuals with severe anti-GBM disease, a rare condition affecting the kidneys and lungs. Participants will receive either imlifidase (an enzyme-based therapy) combined with standard treatments or only the standard treatments to compare outcomes. The trial seeks individuals with anti-GBM antibodies (a type of protein in the blood), blood in their urine, and very low kidney function. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have received IVIg (a type of immune therapy) within 4 weeks before joining, you cannot participate. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that imlifidase is generally safe for patients. In earlier studies, two-thirds of patients with anti-GBM disease who received imlifidase stopped using dialysis within six months. This outcome indicates that the treatment is effective and does not cause serious side effects. Imlifidase has also received approval for severe anti-GBM disease, supporting its safety for this condition. It works by quickly lowering harmful antibodies, which helps protect the kidneys. While all treatments carry some risks, current data suggests that imlifidase is a promising and manageable option for those with severe anti-GBM disease. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Imlifidase is unique because it offers a new approach to treating Goodpasture Syndrome. While standard treatments typically involve a combination of procedures and medications like plasma exchange (PLEX), cyclophosphamide (CYC), and glucocorticoids, imlifidase works by breaking down antibodies that attack the body's own tissues. This mechanism can rapidly reduce harmful antibodies, potentially offering faster relief compared to traditional methods. Researchers are excited about imlifidase because it could provide a quicker, more targeted response, improving outcomes for patients with this challenging condition.

What evidence suggests that imlifidase might be an effective treatment for Goodpasture Syndrome?

Research has shown that current treatments for Goodpasture syndrome, such as plasma exchange (PLEX), cyclophosphamide (CYC), and steroids, often fail to preserve kidney function. Less than 30% of patients retain kidney function after 6 to 12 months. In this trial, participants will receive either the standard-of-care (SoC) treatment alone or in combination with Imlifidase. Researchers are testing Imlifidase because it breaks down the harmful antibodies that attack the kidneys in this disease. Early results suggest that Imlifidase might help maintain kidney function better than existing treatments alone. This potential makes it an important option for those dealing with this condition. ^{1 6 7 8 9}

Who Is on the Research Team?

Clinical Operations

Principal Investigator

Hansa Biopharma AB

Are You a Good Fit for This Trial?

This trial is for adults over 18 with severe anti-GBM disease, indicated by specific kidney function tests and presence of certain antibodies. They must have blood in their urine and not have been treated with standard care or immune globulins recently. Pregnant or breastfeeding individuals, those with conditions posing extra risks, or anuria (no urine output) in the last day are excluded.

Inclusion Criteria

I have antibodies that require a special blood filtering treatment.

My kidney function is severely reduced.

Blood in your urine.

Exclusion Criteria

Unsuitable to participate in the trial for any other reason in the opinion of the investigator

Patients previously randomised in the study

Pregnancy or breast feeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either imlifidase and SoC or SoC alone. Imlifidase is administered IV as one dose of 0.50 mg/kg over 30 minutes.

6 months

Multiple visits (in-person)

Follow-up

Participants are monitored for safety, renal function, anti-GBM antibody levels, and health-related quality of life.

18 months

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Imlifidase

Trial Overview The study compares a new treatment approach using Imlifidase alongside standard therapies like plasma exchange, cyclophosphamide, and glucocorticoids against the standard treatments alone. It's designed to see if adding Imlifidase improves kidney function in patients with anti-GBM disease over two years.

How Is the Trial Designed?

Group I: Imlifidase and Standard-of-Care (SoC) Experimental Treatment 4 Interventions

* 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.

Group II: Standard-of-Care (SoC) Active Control 3 Interventions

SoC consists of a standardized combination of PLEX, CYC, and glucocorticoids.

Who Is Running the Clinical Trial?

Hansa Biopharma AB

Lead Sponsor

Trials

20

Recruited

780+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2949813924000818

Anti–Glomerular Basement Membrane Disease Kidney outcomes in anti–glomerular basement membrane disease remain poor despite significant improvement in patient survival in the last 2 to 3 decades.

2. hansabiopharma.com hansabiopharma.com/media/press-releases/2024/hansa-biopharma-completes-enrolment-in-global-pivotal-phase-3-trial-of-imlifidase-in-anti-glomerular-basement-membrane-disease/

Hansa Biopharma Completes Enrolment in Global Pivotal ... The majority of patients with anti-GBM today lose kidney function and two-thirds experience kidney failure requiring long-term dialysis. We look ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05679401

NCT05679401 | A Study With Imlifidase in Anti-GBM Disease An open-label, controlled, randomised, multi-centre Phase 3 trial evaluating renal function in patients with severe anti-GBM disease comparing imlifidase and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10730795/

Using imlifidase to elucidate the characteristics and ... The prognosis of anti-GBM nephritis with current standard therapy is disappointing, with less than 30% renal survival after 6–12 months, hence, elucidating the ...

5. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/trial/NCT05679401

Imlifidase in Anti-GBM Disease - Clinical Trials at UCLA An open-label, controlled, randomised, multi-centre Phase 3 trial evaluating renal function in patients with severe anti-GBM disease comparing imlifidase and ...

6. hansabiopharma.com hansabiopharma.com/media/press-releases/2020/hansa-biopharm-announces-positive-high-level-data-from-investigator-initiated-phase-2-trial-with-imlifidase-to-treat-anti-gbm-disease/

Hansa Biopharm announces positive high-level data from ... Study concludes that imlifidase leads to rapid clearance of anti-GBM antibodies, with two-thirds of patients achieving dialysis independence six months after ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK459291/

Goodpasture Syndrome - StatPearls - NCBI Bookshelf - NIH Another promising medication is imlifidase, an IgG protease approved for severe anti-GBM disease. Studies show a reduction in antibody ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2468024924034661

Efficacy and Safety of Rituximab in Antiglomerular ... Rituximab has been postulated as a potential treatment for anti-GBM disease; however, data on efficacy and safety are lacking. Methods. We performed a review ...

9. clinicaltrialsarena.com clinicaltrialsarena.com/news/hansa-biopharma-imlifidase/

Hansa starts dosing in Phase III trial in anti-GBM disease In March 2022, Hansa announced that two-thirds of patients achieved dialysis independence after the treatment compared to 18% of patients in a ...