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 @ 29-Oct-2025 04:34:00 UTC
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Showing : 1 – 5 of 143 clinical trials
Advanced Solid Tumour
Metastatic Solid Tumour
IPN01203
Spain
France
Canada
United States of America (the)
Not Yet Recruiting
A study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and anti-tumour activity of IPN01203 in adults with locally advanced or metastatic solid tumours exposed to immune checkpoint inhibitor therapies
The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new drug, IPN01203, in adults with advanced solid tumours.
Advanced solid tumours are cancers that can occur in various organs or tissues and have spread from their original site to nearby tissues or other parts of the body.
There will be two parts to this study:
Phase Ia: This part (called dose escalation) will find the dose range that shows activity against the tumour and can be tolerated by participants by testing different increasing doses of IPN01203. Phase Ib: This part (called dose optimisation) will assess the ability of the drug to prevent, slow down, or stop the growth of tumours and how the body processes and responds to the drug when given in “low dose” or “high dose.” It will also further explore the safety and tolerability.
An additional part (phase II) may be added to the study based on the results of phase Ia and phase Ib.
Each part will consist of the following periods:
A screening period (up to 28 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre.
A treatment period where all eligible participants will receive IPN01203. Requires approximately 15 visits for the first 2 months followed by 3 visits every month from month 3 until unacceptable toxicity, disease progression, death, upon participant’s withdrawal of consent, investigator decision, or study termination by the sponsor, whichever occurs first.
There will also be one visit at the end of treatment (EoT), 30 days after the last administration of the study intervention or prior to the start of new anticancer treatment, whichever is earlier.
Additionally, there will be one visit (the safety follow-up visit) 90 days after the last administration of study intervention or prior to the start of new anticancer treatment, whichever is earlier.
In both parts of the study, participants will undergo blood sampling, urine collection, physical examinations and clinical evaluations. They may continue some other medications, but the details need to be recorded.
Each participant will be in this study until death or withdrawal from the study. IPN01203 will be provided to participants who tolerate it for as long as their disease does not progress. Participants may withdraw consent to participate at any time.
Locally Advanced Solid Tumour
Metastatic Solid Tumour
IPN60300
United States of America (the)
Spain
China
France
Not Yet Recruiting
A study to assess the safety, tolerability, pharmacokinetic, pharmacodynamic, immunogenicity and antitumour activity of IPN60300 in adults with locally advanced or metastatic solid tumours.
This study aims to find the right dosage and evaluate the safety and effectiveness of the drug IPN60300 in adults with advanced solid tumours, which are cancers that have spread to other parts of the body from their original location. All participants will receive the drug by injection.
Study Phases:
Phase Ia: Participants with certain types of tumours will be treated in cohorts of increasingly higher doses of the drug to determine the safe and effective dose range (a high and a low dose).
Phase Ib: Participants with a specific tumour type will receive one of the two doses identified in phase Ia. The dose level will be assigned randomly (by chance).
Study Periods:
Screening: Up to 28 days before first IPN60300 injection to determine eligibility.
Treatment: Starts with the first dose of IPN60300 and continues until it needs to be stopped due to harmful effects, the disease getting worse, or if the participant decides to stop taking part in the study, the investigator’s decision to stop treatment, death or the study is terminated early by the sponsor.
Participants will undergo blood tests, urine collections, physical examinations, and clinical evaluations.
Alagille Syndrome
Bylvay | Kayfanda
Turkey
United Kingdom of Great Britain and Northern Ireland (the)
Poland
Netherlands (Kingdom of the)
Malaysia
Belgium
France
Germany
Italy
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.