A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants with IH

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Takeda Development Center Americas Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

27 May 2025 → ongoing

Decision date (initial)

2025-05-09

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Takeda Development Center Americas, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Dose response, Pharmacokinetic, Efficacy, Pharmacodynamic

To evaluate the safety and tolerability of TAK360 based on the posttreatment adverse event profile

Secondary objectives 2

1. To assess the effect of TAK-360 on excessive daytime sleepiness (EDS) as measured by the Epworth Sleepiness Scale (ESS) total score after 4 weeks of treatment.
2. To assess the severity of idiopathic hypersomnia (IH) as measured by the IH Severity Scale (IHSS) after 4 weeks of treatment.

Conditions and MedDRA coding

Idiopathic Hypersomnia (IH)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. The participant is aged 18 to 70 years (inclusive) at the time of signing the ICF.
2. The participant weighs ≥40 kg and has a BMI between 16 and 38 kg/m2 (inclusive).
3. The participant has a documented, current diagnosis of IH, established or confirmed within the last 5 years.

Exclusion criteria 30

1. The participant is not willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator.
2. The participant has a current history of significant multiple and/or severe allergies (for example, food, drug, or latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food which in the PI's opinion poses a significant risk to the participant to participate in trial.
3. The participant has a clinically significant history of head injury or head trauma.
4. The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood)
5. The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
6. The participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, based on any of the following: a. The participant has attempted suicide within the past year before screening. b. The participant answers yes to items 4 or 5 on the C-SSRS (at any time in the past year) before randomization.
7. The participant lacks suitable venous access for the trial-required blood sampling.
8. The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs (that is, a history of malabsorption, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention). Any history of Roux-en-Y gastric bypass is considered exclusionary, and any other surgical intervention that may influence the absorption of drugs should be discussed and approved by the sponsor or designee before enrolling the participant.
9. The participant had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.
10. Unwilling or unable to refrain from using any of the excluded medications listed in the protocol, Medications that could interfere with clinical or laboratory assessments.
11. The participant has signs of substance abuse.
12. The participant has not provided informed consent (that is, in writing, documented via a signed and dated ICF) and any required privacy authorization before the initiation of any trial procedures.
13. The participant is unable to refrain from or anticipates using excluded food products or prohibited medication.
14. If the participant is a WOCBP: The participant has a positive pregnancy test at screening or on Day -2 or is lactating/breastfeeding.
15. If the participant is a fertile man: The participant does not agree to use a condom, preferably combined with at least 1 form of acceptable contraception for any WOCBP
16. The participant has participated in another investigational drug trial, in which they received the investigational drug. The interval window from the previous trial will be derived from the date of the last dose of investigational drug in the previous trial to the screening visit of the current trial. Exceptions may be made for observational, natural history and nonintervention type studies with sponsor or designee approval. Note: This does not apply to past participation in studies of approved drugs, for which rules are specified in the protocol.
17. If the participant is male and has a pregnant partner: The participant does not agree to use a condom during sexual intercourse OR to abstain from sex.
18. The participant has any prior exposure to an oral Takeda OX2R agonist within the past 3 months. Note: Participants who were randomized or received IMP in a prior clinical trial with TAK-925 are not excluded.
19. The participant plans to participate in any other interventional trial while participating in TAK-360-2002 or has previously participated in another cohort in TAK-360-2002.
20. The participant is considered to be vulnerable, as defined per local regulations and if exclusion is required by local regulations. Examples are persons under safeguard of justice, persons deprived of liberty by judicial or administrative decision, persons performing mandatory military service, persons receiving psychiatric care without their consent, persons admitted to a health or social establishment for purposes other than research, persons of full age who are subject to a legal protection measure (guardianship or curatorship), and persons unable to express their consent.
21. The participant, in the opinion of the investigator or subinvestigator, is unlikely to comply with the protocol, has a medical condition that would preclude enrollment, or is unsuitable for any other reason.
22. The participant has a current medical disorder associated with EDS (other than IH).
23. The participant has a usual bedtime later than 1:00 AM , an occupation requiring nighttime shift work or variable shift work within the past 6 months, has travelled with significant jet lag within 14 days before Day -2, or plans for travel with significant jet lag during the trial.
24. The participant has any of the following cardiac conditions: QTcF >450 ms (males) or >470 ms (females) on the screening ECG; a history, diagnosis, or suspicion of clinically significant coronary artery disease, a history of heart failure, myocardial infarction or clinically significant angina, a history of clinically significant cardiac rhythm abnormality in the judgement of the investigator
25. The participant has medically significant thyroid disease.
26. The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ [such as basal cell carcinoma] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor.)
27. The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), Hepatitis C virus antibody (at screening), HIV antibody/antigen (at screening).
28. The participant has a suspected intolerance or known hypersensitivity to TAK-360, closely related compounds, or any component of the formulation of TAK-360.
29. The participant consumes excessive amounts of caffeine
30. The participant is a trial site employee, a site employee’s immediate family member (for example, spouse, parent, child, sibling), or is in a dependent relationship with a site employee who is involved in conduct of this trial or may consent under duress.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Occurrence of at least 1 treatment-emergent adverse event (TEAE) during the trial.

Secondary endpoints 2

1. Change from baseline at Week 4 in ESS total score, as compared to placebo.
2. Change from baseline at Week 4 in IHSS total score, as compared to placebo.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Takeda Development Center Americas Inc.

Sponsor organisation

Takeda Development Center Americas Inc.

Address

500 Kendall Street

City

Cambridge

Postcode

02142-1108

Country

United States

Scientific contact point

Organisation

Takeda Development Center Americas Inc.

Contact name

Christopher Silber

Public contact point

Organisation

Takeda Development Center Americas Inc.

Contact name

Takeda

Third parties 17

Locations

3 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 36 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications