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.
Only interventional studies that have started within the last 20 years and completed within the 2 last years will be displayed.
The study results will be available on ClinicalTrials.gov from 12 months after the end of the study.
Last Data Refreshed @ 19-Mar-2026 05:16:21 UTC
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Showing : 1 – 5 of 142 clinical trials
Primary Sclerosing Cholangitis
Iqirvo
Germany
Hungary
Bulgaria
Finland
Argentina
Italy
Israel
Greece
Australia
Czechia
Denmark
Canada
China
France
Romania
Portugal
Norway
Spain
Slovakia
Poland
Belgium
Korea (the Republic of)
Lithuania
Japan
Netherlands (Kingdom of the)
United Kingdom of Great Britain and Northern Ireland (the)
Brazil
Sweden
United States of America (the)
Not Yet Recruiting
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
The purpose of this study is to find out how well and safely elafibranor works compared to placebo in adult participants with Primary sclerosing cholangitis (PSC). PSC is a rare disease that causes inflammation and scarring of the bile ducts in the liver. Over time, this can lead to liver damage and serious health problems, including the need for a liver transplant and death.
In this study, about 350 participants with large duct PSC will take part. Participants will be randomized to receive either elafibranor 120 mg once daily or a placebo (a tablet with no active medicine). The study includes a screening period, an treatment period, and a post-treatment safety follow-up.
During the study, participants will undergo routine clinical assessments, laboratory testing, imaging evaluations, and complete patient-reassessments to evaluate liver disease progression, symptoms, quality of life and safety.
Following the end of treatment, participants will complete a safety follow-up period at approximately four weeks. Participants may withdraw from the study at any time. Each participant may be in the study for several years, as the treatment period will continue until the study reaches enough health events among participants, which is expected to take about 5 years.
Low-grade Glioma
tovorafenib
Japan
Not Yet Recruiting
A study to assess a medicine called tovorafenib in Japanese children and young adults with brain tumours
The purpose of this study is to evaluate safety and the way the body absorbs, distributes and gets rid of the study drug tovorafenib in the body in Japanese children, adolescents and young adults with specific brain tumours. This includes how the drug is absorbed, distributed and eliminated from the body (called pharmacokinetics). The study will also test how well the drug works to shrink brain tumours.
In this study, all participants will receive tovorafenib orally once weekly.
There will be four periods in this study:
1. Screening period (up to 4 weeks): Participants will be evaluated to determine if they can take part in the study, requiring at least one visit to the study centre.
2. Treatment period (up to 24 months): All eligible participants will receive tovorafenib.
This requires five visits for the first 2 months (Cycle 1 and Cycle 2) followed by one visit every month (at the start of each treatment cycle). Participants will receive the first oral dose of tovorafenib on Day 1 of Cycle 1 at the study clinic. After Day 1, participants will need to take tovorafenib once weekly on Day 8, Day 15 and Day 22. Participants will be required to come to the study clinic in person at least five times for Cycle 1 and Cycle 2.
In addition, participants will have one remote visit (telephone call) during Cycle 1. After Cycle 2, only one in-person clinic visit is required at the start of each treatment cycle. A participant will stop treatment if their disease gets worse, if treatment has a harmful effect, or if they do not want to take part in the study anymore.
3. End-of-Treatment Safety Follow-Up (30 days): Participants will have a clinic visit 30 days after stopping treatment to check their health.
4. Long-Term Follow-Up (up to 2 years): Participants will be monitored every 3 months unless they start a new anti-cancer treatment or leave the study.
During the study, participants will undergo various health measurements and observations, including blood sampling and urine collections. Each participant will be in this study for up to approximately 4 years. Tovorafenib will be provided to participants who tolerate it for as long as their disease does not progress.
Once tovorafenib becomes approved and commercially available in Japan, participants may transition to the commercial drug for continued treatment.
A participant may withdraw consent to participate at any time.
Alagille Syndrome
Bylvay | Kayfanda
France
Italy
Australia
Germany
Poland
Malaysia
Netherlands (Kingdom of the)
Turkey
United Kingdom of Great Britain and Northern Ireland (the)
United States of America (the)
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.
Colorectal Cancer
Head And Neck Squamous Cell Carcinoma
Melanoma
Pancreatic Ductal Adenocarcinoma
Solid Tumor
IPN01194
Spain
France
United States of America (the)
Recruiting
A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours.
The participants in this study will have advanced solid tumours. ‘Advanced solid tumours’ refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.
In this study, all participants will receive the study drug, which will be taken by mouth (orally).
Detailed Description: The study consists of two parts, called Phase I and Phase IIa.
Phase I is designed to assess the safety of increasing doses of IPN01194 in participants with specific types of advanced solid tumours.
The aim of this “dose escalation” phase is to find the dose range showing activity on the tumor that can be tolerated by the participants, and to determine the two doses for further testing in Phase IIa. Phase I will assess how the body processes and responds to the study drug when administered with and without food.
In Phase IIa, participants with selected single tumour type will be invited to take part. During this phase, the two dose levels of the study drug identified from Phase I will be tested. Participants will take the study drug one of the two dose levels. Each participant will be assigned to a dose level at random (by chance).
Each phase will consist of three periods:
1- A period to assess eligibility (screening period) that will take up to 28 days.
2- A treatment period of at least 28 days that will require at least two visits for the first month followed by one visit every month. There will be also one visit, at the end of treatment, at least 30 days after the last administration of study drug.
3- A follow-up period (Phase IIa participants only), where every 3 months, participants will be contacted by phone, until death or the study cut-off date, whichever comes first.
Participants will undergo blood samplings, urine collections, physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded.
If in the opinion of the investigator a participant is continuing to experience clinical benefit after the cut-off date, the participant may remain in the study and continue to receive the study drug until either disease progression, unacceptable toxicity or other withdrawal criteria are met.
Advanced Solid Tumours
IPN01195
France
Italy
Spain
United States of America (the)
Recruiting
A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new study drug IPN01195 in adults with advanced solid tumours.
The participants in this study will have advanced solid tumours. ‘Advanced solid tumours’ refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.
The study consists of two phases, called phase I and phase II.
Phase I will be conducted in two parts:
Part A: Phase I Part A study (dose escalation) is designed to find the dose range showing activity on the tumour that can be tolerated by the participants by testing different doses of IPN01195.
Part B: Phase I Part B of the study (dose confirmation) will assess the ability of study drug to prevent, slow down, or stop the growth of tumours (abnormal cell growths that can lead to cancer) and how the body processes and responds to the study drug when administered in a “low dose” or “high dose” and further explore the safety and tolerability.
These parts will consist of the following periods:
A period to assess eligibility (screening period).
A treatment period that will require at least two visits for the first month followed by one visit every month. There will be also one visit, at the end of treatment, at 30 days after the last administration of study drug.
An assessment visit will be required every 6 weeks up to Week 24 and every 12 weeks thereafter to measure the tumour again and to assess how it is evolving, whether it is getting bigger, smaller, is stable or has gone away.
Based on the results obtained from phase I, a phase II extension study will be included through to an updated study plan, to further evaluate the study drug.
In both study phases, participants will undergo blood samplings, urine collections, physical examinations and clinical evaluations. They may continue some other medications, but the details need to be recorded.