臨床研究等提出・公開システム

An open-label, non-randomized extension study to evaluate the long-term efficacy, safety and tolerability of iptacopan (LNP023) in C3 glomerulopathy or idiopathic immunecomplex-membranoproliferative glomerulonephritis (CLNP023B12001B)

Long-term efficacy, safety and tolerability of iptacopan in C3G or IC-MPGN (CLNP023B12001B)

Maruyama Hideki

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku@novartis.com

Maruyama Hideki

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku@novartis.com

Recruiting

Dec. 01, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Written informed consent must be obtained before any assessment is performed.
2. Male and female participants 12 years of age or greater at screening.
3. Participants must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug.
4. Adult participants must be able to communicate well with the investigator, understand and comply with the requirements of the study [applicable in Germany only]
4a. Participants or their legal representatives must be able to communicate well with the investigator, understand and comply with the requirements of the study [applicable in all countries except in Germany for adult participants].

1. Severe concurrent co-morbidities, e.g. advanced cardiac disease (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.
2. Participants with an active systemic bacterial, viral or fungal infection within 14 days prior
to screening, or The presence of fever >= 38 degree Celsius (100.4 degree Fahrenheit) within 7 days prior to screening.
3. History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants participating in the study such as:
-Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second- or third-degree AV block without a pacemaker
-History of familial long QT syndrome or known family history of Torsades de Pointe.
4. Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of the study.
5. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.

Both

Complement component 3 glomerulopathy, Immune-complex-membranoproliferative glomerulonephritis

Iptacopan(LNP023) 200 mg b.i.d.

Occurrence of clinically significant vital signs (msDBP, msSBP, heart rate), ECGs, and safety laboratory measurements, as well as adverse events (AEs), AEs of special interest, and study drug discontinuation due to an AE (or any safety issue).

+81-52-744-1958

Nov. 01, 2022

No

Argentina/Belgium/Brazil/Canada/China/Czech Republic/France/Germany/Greece/India/Israel/Italy/Netherlands/Spain/Switzerland/Turkey/UK/US