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Long-term safety and tolerability of iptacopan in patients with Paroxysmal Nocturnal Hemoglobinuria
EU CTIS ID: 2023-509843-28-00
What this study is testing
To evaluate the long-term safety and tolerability of iptacopan monotherapy in participants who have completed the treatment extension period (without tapering down) of the previous Phase II and any Phase III clinical studies with iptacopan
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female participants ≥ 18 years of age with a diagnosis of PNH who have completed the treatment extension period (without tapering down) of Phase II iptacopan studies (CLNP023X2204, CLNP023X2201), Period 4 of CLFGX2201 or completed any Phase III (eg. CLNP023C12302, CLNP023C12301, CLNP023C12303) clinical study at the time point of enrollment visit in this roll over extension study
- Prior vaccinations against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e., any boosters required administered according to local regulations).
- Per investigator’s clinical judgement, the patient may benefit from continued treatment with iptacopan and has been clinically stable on iptacopan monotherapy for at least 3 months
You likely can't join if
- Any comorbidity or medical condition (including but not limited to any active systemic bacterial, viral or fungal infection or malignancy) that, in the opinion of the investigator, could put the subject at increased risk or potentially confound study data
- History of recurrent invasive infections caused by encapsulated organisms, such as Neisseria meningitidis, Streptococcus pneumoniae or Haemophilus influenzae
- Female participants who are pregnant or breastfeeding, or intending to conceive during the course of the study
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using effective methods of contraception during dosing of investigational drug and for 1 week after stopping investigational drug. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms).
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Malaysia
- China
- United States
- Turkey
- Taiwan
- Singapore
- Brazil
- Korea, Republic of
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Malaysia; China; United States; Turkey; Taiwan and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.