This study has been transitioned to CTIS with ID 2023-509343-27-00 check the CTIS register for the current data. Participants enrolling from study CLNP023B12301 or CLNP023B12302• Primary Objective: To evaluate the long-term safety and tolerability…
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Primary Efficacy Objective (Cohort A - native C3G): To characterize the
effect of treatment with iptacopan on a composite renal endpoint at the 9-month
visit
• Primary Safety Objective: To evaluate the long-term safety and tolerability
of iptacopan in participants with C3G
Secondary outcome
• To assess the effect of treatment with iptacopan on a 2-component composite
renal endpoint at the 9-month visit
• To assess the long-term effect of iptacopan on renal function in C3G
participants at the 9-month visit
• To assess the effect of iptacopan on proteinuria in C3G participants at the
3-month visit
• To describe the status of C3G disease progression based on glomerular
histopathology in a renal biopsy at the 6- to 9-month visit
• To evaluate the long-term effect of iptacopan on C3 at the 9-month visit
• To assess the longer-term (>9 months of treatment in CLNP023B12001B) effects
of iptacopan on the composite renal endpoint, renal function and C3 in C3G
participants
• To evaluate the pharmacokinetics of iptacopan in participants with prolonged
treatment
Background summary
The primary purpose of this extension study is to collect and evaluate
long-term efficacy, safety and tolerability data in eligible participants
receiving open-label iptacopan (LNP023) after completing treatment in the C3G
Phase 2 proof of concept (PoC) study CLNP023X2202, C3G Phase 3 study
CLNP023B12301 or IC-MPGN Phase 3 study CLNP023B12302. Efficacy and safety
assessments at the 9- month visit of this extension study in combination with
data from CLNP023X2202 (baseline plus 3 months of treatment) allowed evaluation
of the effects of iptacopan on potential endpoint(s) at 12 months of iptacopan
treatment in C3G participants. The enrollment of C3G and IC-MPGN participants
(adults and adolescents) from Phase 3 studies CLNP023B12301 and CLNP023B12302
permits long-term evaluation of the persistence of effects observed after
iptacopan treatment up to 12 months. These longer-term efficacy and safety
assessments may be used as supportive information for registration purposes.
Study objective
This study has been transitioned to CTIS with ID 2023-509343-27-00 check the CTIS register for the current data.
Participants enrolling from study CLNP023B12301 or CLNP023B12302
• Primary Objective: To evaluate the long-term safety and tolerability of
iptacopan in participants with C3G or IC-MPGN
Study design
CLNP023B12001B is an open-label extension of CLNP023X2202, a Phase 2, open
label study evaluating iptacopan in two patient populations with C3G - native
kidneys (Cohort A) and kidney transplant with recurrence (Cohort B).
Furthermore, all participants completing iptacopan treatment from two ongoing
Phase 3 studies were given the option to transition into this extension study:
CLNP023B12301 (C3G) and CLNP023B12302 (IC-MPGN)
Participants completing treatment in the CLNP023X2202, CLNP023B12301 or
CLNP023B12302 studies, who want to continue treatment and meet the
inclusion/exclusion requirements of the extension study will have the
opportunity to receive iptacopan until drug product becomes commercially
available and accessible, or the benefit-risk profile is no longer positive, or
the program is discontinued for business or strategic reasons.
Intervention
Iptacopan (LNP023) at a dose of 200 mg b.i.d.
Study burden and risks
Demographics, medical history and evaluation of inclusion and exclusion
criteria: 1x
Pregnancy test for women of childbearing age: 10x
Vital signs (pulse, blood pressure) and/or body temperature: 9x
Physical examination: 9x
Weight and height: 1x
ECG: 8x
Urine collection: 9x
Mid-stream urine collection: 9x
24-hour urine collection: 1x
Blood tests: 9x
Questionnaires: 2x
Tanner puberty scale: 6x (only in adolescents)
Echocardiography: 1x (only in adolescents)
Haaksbergweg 16
Amsterdam 1101 BX
NL
Haaksbergweg 16
Amsterdam 1101 BX
NL
Listed location countries
Age
Inclusion criteria
Participants must have completed the treatment period of the CLNP023X2202, or
CLNP023B12301 or CLNP023B12302 trial study on study drug.
Exclusion criteria
• Severe concurrent co-morbidities, e.g., advanced cardiac disease (New York
Heart Association (NYHA) class IV), severe pulmonary arterial hypertension (WHO
class IV), or any illness or medical condition that in the opinion of the
investigator and sponsor is likely to prevent the patient from safely
tolerating iptacopan or complying with the requirements of the study.
• Participants with an active systemic bacterial, viral or fungal infection
within 14 days prior to screening,
or
The presence of fever >= 38C (100.4F) within 7 days prior to screening.
• History of human immunodeficiency virus (HIV) or any other immunodeficiency
disease.
• History or current diagnosis of ECG abnormalities indicating significant risk
of safety for participants.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-509343-27-00 |
| EudraCT | EUCTR2018-004253-24-NL |
| ClinicalTrials.gov | NCT03955445 |
| CCMO | NL82423.056.22 |