An Open-Label Phase II Study to Evaluate the Efficacy and Safety of IdeS in Anti-GBM Disease (GOOD-IDES)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03157037
• Date of registration: 11/05/2017
• Prospective Registration: No
• Primary sponsor: Mårten Segelmark
• Public title: An Open-Label Phase II Study to Evaluate the Efficacy and Safety of IdeS in Anti-GBM Disease (GOOD-IDES) GOOD-IDES
• Scientific title: An Open-Label Phase II Study in Anti-GBM Disease (Goodpasture's Disease) With Adverse Renal Prognosis to Evaluate the Efficacy and Safety of IdeS --GOOD-IDES
• Date of first enrolment: March 1, 2017
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03157037
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Austria, Czechia, Denmark, France, Sweden

Contacts

• Name: Mårten Segelmark, MD PhD Prof
• Affiliation: Linkoeping University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Anti-GBM antibodies detected by ELISA above a level that is considered toxic by the
investigator using local laboratory. Patients double-positive for anti-GBM and ANCA
may be entered in the trial, but only if their level of anti-GBM antibodies fulfil the
criteria listed above.

2. eGFR < 15 ml/min/1.73 m2 (by MDRD equation) or if the patient is non-responsive to
standard treatment, and has lost >15 ml/min/1.73 m2 after start of treatment

3. Haematuria on dipstick and/or urinary sediment

4. Male or female patients aged at least 18 years; Female patients of childbearing
potential may participate if highly effective contraception is used during the study,
according to CTFG guidance [18], see also section 4.9 (pregnancy test should be
performed before inclusion).

5. Willing and able to give written Informed Consent and to comply with the requirements
of the study protocol; and

6. Judged to be otherwise healthy by the Investigator, based on medical history, physical
examination, and clinical laboratory assessments. Patients with clinical laboratory
values that are outside of normal limits (other than those specified in the Exclusion
Criteria) and/or with other abnormal clinical findings that are judged by the
Investigator not to be of clinical significance, may be entered into the study.

Exclusion Criteria:

1. Anuria for more than 2 days (less than 200 ml during last 48 hours);

2. Dialysis dependency for more than 5 days (maximum 3 sessions before signing informed
consent);

3. Ongoing moderate to severe pulmonary haemorrhage (or having ceased within the last two
weeks), defined as requiring assisted ventilation, oxygen or blood transfusions.

4. Pregnancy.

5. Symptomatic congestive heart failure (NYHA class 2-4) and requiring prescription
medication or clinically evident peripheral edema of cardiac origin;

6. Myocardial infarction, unstable angina or stroke within 3 months prior to screening;

7. Ongoing bacterial infection requiring antibiotic therapy or viral infection with
Hepatitis B, C or HIV (up to 3 months old negative test results are accepted); or
active tuberculosis as indicated by chest x-ray.

8. Patients should not have received investigational drugs within 30 days prior to
screening or within 4 half-lives (whichever is longer); and

9. History or presence of any medical condition or disease which, in the opinion of the
Investigator, may place the subject at unacceptable risk for study participation.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Anti-Glomerular Basement Membrane Disease

Intervention(s)

Biological: HMed-IdeS

Primary Outcome(s)

Proportion of patients with independent renal function at 6 months [Time Frame: 6 months after dosing]

Secondary Outcome(s)

Change in proteinuria during the study [Time Frame: 6 months after dosing]

Pharmacokenetics [Time Frame: Day 0 to day 14 after dosing]

The proportion of subjects with independent renal function, defined as no need for dialysis at 3 months, as compared to historical controls. [Time Frame: 3 months after dosing]

Renal histology [Time Frame: 6 months after dosing]

Number of PLEXs needed [Time Frame: 6 months after dosing]

Pharmacodynamics (IgG degradation) [Time Frame: Day 0 to day 28 after dosing]

Renal function at 3 and 6 months [Time Frame: 3 and 6 months after dosing]

Disappearance of haematuria [Time Frame: 6 months after dosing]

Anti-IdeS antibodies (ADA) [Time Frame: 6 months after dosing]

Number of days with anti-GBM antibodies above a toxic level [Time Frame: 6 months after dosing]

Secondary ID(s)

GOOD-IDES-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hansa Biopharma AB