On this page you can find clinical trials that Ipsen has sponsored and clinical trials that were acquired by Ipsen. You can use the drop-down lists below to find clinical trials by condition, status, phase and country.
Completed clinical trials may also have results available. If so, a simple summary of the overall results can be found on the lay summaries page.
You may also find a scientific summary of the results on the US and EU Clinical Trial Registries.
The ‘status’ of participant recruitment is defined as follows:
- Not yet recruiting – recruitment has not started yet
- Recruiting – recruitment is open
- Enrolling by invitation – recruitment is open to a particular population who are invited to participate.
- Active, not recruiting – recruitment is closed, participants are still ongoing in the clinical trial;
- Terminated – the study stopped early.
- Completed – the study ended.
Last Data Refreshed @ 04-Dec-2024 05:18:01 UTC
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Showing : 1 – 5 of 142 clinical trials
Follicular Lymphoma
Refractory Follicular Lymphoma
Tazverik
United States of America (the)
Not Yet Recruiting
A study to assess efficacy and safety of oral tazemetostat in adult participants with relapsed/refractory follicular lymphoma that does not have an “EZH2 gain-of-function” genetic mutation
The purpose of this research study is to learn about the effectiveness and safety of the study drug, tazemetostat, in adults with relapsed/refractory follicular lymphoma whose tumours do not have an “EZH2” genetic mutation. Follicular lymphoma is a blood cancer. It affects white blood cells called lymphocytes. White blood cells normally help to fight infections, but when you have follicular lymphoma, the blood cells can form tumours in your body. ‘Relapsed/refractory’ follicular lymphoma means the disease has either not improved or is getting worse (progressing) during or after previous treatment. Tazemetostat already has approval in the United States for the treatment of adult patients with relapsed/refractory follicular lymphoma with or without the “EZH2” mutation who have no satisfactory alternative treatment options. This study is being conducted to better understand the effectiveness in patients whose tumours do not have an “EZH2” genetic mutation and who previously received therapies commonly used in the U.S. in your body. ‘Relapsed/refractory’ follicular lymphoma means the disease has either not improved or is getting worse (progressing) during or after previous – 5 – SM D form protocol master data -INT / Version 1 treatment. Tazemetostat already has approval in the United States for the treatment of adult patients with relapsed/refractory follicular lymphoma with or without the “EZH2” mutation who have no satisfactory alternative treatment options. This study is being conducted to better understand the effectiveness in patients whose tumours do not have an “EZH2” genetic mutation and who previously received therapies commonly used in the U.S. In this study, all participants will receive the study drug. It will be taken by mouth (orally), as a tablet, twice daily. The sizes and number of tumours according to scan results will be collected as well as results of safety tests (such as physical examinations and laboratory tests). The study consists of 3 or 4 periods: ? Screening period may take up to 4 weeks and require at least 1 visit. ? Treatment period will require 2 visits for each of the first 2 months, followed by 1 visit every month for the remainder of the first 6 months, followed by 1 visit every 3 months (except for women of childbearing potential [WOCBP], who will continue to have a visit every month) until unacceptable toxicity, disease progression, or the start of new systemic anticancer therapy, whichever is first. ? Safety follow -up period will last for 1 month after the last dose of tazemetostat, and it will end with 1 visit or telephone call. ? Long -term follow -up period is only for participants who stop taking tazemetostat while their disease continues to respond; this period will last until disease progression, start of new cancer treatment, or death from any cause, whichever is first. Tazemetostat will be provided to participants who tolerate it for as long as their disease does not progress. Participants may be transferred to another study or program after about 2 years for continued treatment with tazemetostat or for long-term follow-up. Patients may withdraw consent to participate at any time.
Primary Sclerosing Cholangitis
ritivixibat
Italy
France
Spain
Poland
Recruiting
Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis
This study will test a drug called A3907 to see how safe and tolerated it is for treating people with Primary Sclerosing Cholangitis (PSC). Detailed Description: The primary goal of this study in participants with PSC with and without a Clinically Relevant Stricture (CRS) who are treated with A3907 is to assess the safety and tolerability of A3907 following repeat doses. Secondary goals include evaluation of the pharmacokinetic properties of A3907 (the study of how the body interacts with A3907 for the entire duration of exposure) and changes in safety parameters via laboratory testing such as liver enzymes, bile acid levels and markers of bile acid synthesis.
Alagille Syndrome
Bylvay | Kayfanda
Poland
Malaysia
Netherlands (Kingdom of the)
Belgium
United States of America (the)
Turkey
United Kingdom of Great Britain and Northern Ireland (the)
France
Italy
Germany
Recruiting
Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome
The purpose of this study is to assess the long-term safety and effectiveness of odevixibat in participants with Alagille syndrome (ALGS). The participants of this study will have ALGS a rare genetic disorder that can affect multiple organ systems of the body including the liver, heart, skeleton, eyes and kidneys. Common symptoms, which often develop during the first three months of life, include blockage of the flow of bile from the liver (cholestasis), yellowing of the skin and mucous membranes (jaundice), poor weight gain and growth and severe itching (pruritis). Detailed Description: This Phase 3, open-label, multi-center extension study will have two groups of participants: Cohort 1 (participants who participated in Study A4250-012 [NCT04674761; ASSERT] and meet the entry criteria for this study) and Cohort 2 (infants under 12 months of age) with ALGS. The study will consist of 2 or 3 periods: A ‘Treatment period’ of 72 weeks (cohort 1) or 12 weeks (cohort 2). Participants will visit the clinic every 4 to 12 weeks and will receive a dose of 120 ?g/kg odevixibat daily. An ‘Optional extension period’ where participants who wish to continue receiving odevixibat after the ‘treatment period’ will have the opportunity to remain on treatment with visits every 16 weeks until the drug is commercially available. The optional extension is available provided continued use is supported by the risk-benefit profile, the participant has not been previously withdrawn or discontinued from the study, and the study is not terminated by the Sponsor. A ‘Safety follow-up period’ of 4 weeks (cohort 1) or 2 weeks (cohort 2). The Safety Follow-up Period will not occur for those who remain on treatment in the optional extension period. Participants will need to complete an e-diary and questionnaires throughout the study (cohort 1 only). Participants will undergo blood samplings, urine collections (cohort 1 only), physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded.
Primary Biliary Cholangitis
Iqirvo
United States of America (the)
France
Czechia
Germany
Korea (the Republic of)
Spain
Poland
Recruiting
A Study of Elafibranor in Adults with Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid
The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease. Primary biliary cholangitis is a slowly progressive disease characterised by damage of the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many patients with PBC may require a liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment). The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease. There will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants’ health will be monitored. Participants will be twice as likely to receive elafibranor than placebo (2:1 ratio). Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a noninvasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (a noninvasive test that passes a probe on skin to measure stiffness of the liver). They will also be asked to fill in questionnaires. Each participant will be in this study for up to 64 weeks (15 months).
Moderate To Severe Upper Facial Lines
IPN10200
Germany
France
Recruiting
A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines
The purpose of this study is to assess the safety and efficacy profile of increasing doses of IPN10200 in comparison to placebo, with the aim to discover the doses(s) that offer the best efficacy/safety profile when used for the treatment of moderate to severe Upper Facial Lines. This study will be conducted in three stages. The full study (including all stages) will have a maximum 448 participants. The protocol is currently approved up to stage 1, step 1 and stage 1/ step 2. Stage 1 (phase Ib & II) Step 1 (Phase Ib): a dose-escalation first-in-human step in participants with moderate to severe Glabellar Lines (GL) Step 2 (Phase II): dose finding step in participants with moderate to severe GL as compared with Dysport Stage 2 (phase II) – An evaluation of efficacy and safety of IPN10200 in one of the following regions: GL + forehead lines (FHL) or lateral canthal lines (LCL) Stage 3 (phase II) – A safety and efficacy evaluation of IPN10200 in all three regions (GL, FHL and LCL)