A Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants with Narcolepsy without Cataplexy (NT2)

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

4 Dec 2025 → ongoing

Decision date (initial)

2025-11-14

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Takeda Development Center Americas, Inc.

External identifiers

EU CT number

2024-517711-70-01

ClinicalTrials.gov

NCT06952699

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

To evaluate the safety and tolerability of TAK-360

Secondary objectives 2

1. To assess the effect of TAK-360 on (EDS) as measured by the total score after 4 weeks of treatment.
2. To assess the effect of TAK-360 on EDS as measured by sleep latency in the MWT after 4 weeks of treatment.

Conditions and MedDRA coding

Narcolepsy without Cataplexy (NT2)

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 1.The participant is an adult participant aged 18 to 70 years (inclusive) at the time of signing the ICF.
2. 2.The participant weighs ≥40 kg and has a BMI between 16 and 38 kg/m2 (inclusive).
3. 3.The participant has a documented, current diagnosis of NT2

Exclusion criteria 28

1. 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. 2. 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.
3. 3. The participant has a current medical disorder associated with EDS
4. 4. 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.
5. 5. The participant has any of the following cardiac conditions: QT interval with Fridericia correction method (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.
6. 6. The participant has medically significant thyroid disease
7. 7. 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).
8. 8. The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), Hepatitis virus antibody (at screening), HIV antibody/antigen (at screening)
9. 9. The participant has a suspected intolerance or known hypersensitivity to TAK-360, closely related compounds, or any component of the formulation of TAK-360.
10. 10. 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
11. 11. The participant has a clinically significant history of head injury or head trauma.
12. 12. The participant has a history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
13. 13. The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
14. 14. 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.
15. 15. The participant lacks suitable venous access for the trial-required blood sampling
16. 16. 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).
17. 17. The participant had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.
18. 18. Unwilling or unable to refrain from using any of the excluded medications listed in the protocol, including: Medications that could interfere with clinical or laboratory assessments.
19. 19. The participant consumes excessive amounts of caffeine
20. 20. The participant is unable to refrain from or anticipates using excluded food products or prohibited medication
21. 21. If the participant is a WOCBP: The participant has a positive pregnancy test at screening or on Day -2 or is lactating/breastfeeding.
22. 22. If the participant is a fertile male: The participant does not agree to use a condom, preferably combined with at least 1 form of acceptable contraception for any WOCBP partner(s)
23. 23. 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 trials of approved drugs, for which rules are specified in the protocol.
24. 24. The participant plans to participate in any other interventional trial while participating in TAK-360-2001.
25. 25. The participant has any prior exposure to an oral Takeda OX2R agonist within the past 3 months.
26. 26. 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.
27. 27. 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.
28. 28. The participant, in the opinion of the investigator or sub-investigator, is unlikely to comply with the protocol, has a medical condition that would preclude enrollment, or is unsuitable for any other reason

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Occurrence of at least 1 (TEAE) during the trial.

Secondary endpoints 2

1. 1. Change from baseline at Week4 in ESS total score, as compared with placebo.
2. 2. Change from baseline at Week 4 in mean sleep latency on the MWT, as compared with 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 15

Locations

3 EU/EEA countries · 5 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 34 files

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

Application history

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