A Study to Assess the Effectiveness and Safety of Taplucainium Inhalation Powder (NOC-110) in Adults with Refractory or Unexplained Chronic Cough

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Nocion Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

18 Dec 2024 → ongoing

Decision date (initial)

2024-11-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

To evaluate the effects of Taplucainium Inhalation Powder (NOC-110) once daily for 28 days at three dose levels: 1 mg, 3 mg, and 6 mg, versus Placebo on 24-hour cough frequency in Adults with Refractory or Unexplained Chronic Cough (rCC or uCC).

Secondary objectives 3

1. To evaluate the effects of NOC-110 once daily for 28 days at three dose levels: 1 mg, 3 mg, and 6 mg, versus Placebo on Awake-cough frequency.
2. To evaluate the impact of NOC-110 once daily for 28 days at three dose levels: 1 mg, 3 mg, and 6 mg, versus Placebo on measures of Quality of Life.
3. To evaluate the Safety and tolerability of NOC-110 once daily for 28 days at three dose levels: 1 mg, 3 mg, and 6 mg, versus Placebo.

Conditions and MedDRA coding

Refractory or Unexplained Chronic Cough

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Refractory or unexplained chronic cough for ≥ 12 months
2. Women of childbearing potential agree to follow the protocol-specified contraceptive guidance during the study
3. Males who are not vasectomized must agree to use the contraceptive methods defined in the protocol
4. Able to provide Informed Consent

Exclusion criteria 15

1. Previous exposure to taplucainium (formerly NTX-1175) or known allergy or hypersensitivity to taplucainium, its excipients/metabolites, or related compounds.
2. Participants who are currently participating in another drug or device clinical study
3. Participants who have participated in an Acute or Chronic Cough investigational study within 60 days before the start of the Screening.
4. Current diagnosis of chronic obstructive pulmonary disease (COPD), bronchiectasis, unexplained pulmonary fibrosis, hemoptysis, bronchial asthma (not including resolved childhood asthma), or other pulmonary disease
5. Respiratory tract infection within 4 weeks of Screening.
6. Any female who is pregnant or lactating or wishing to become pregnant.
7. Donation of > 1 Unit (450 milliliter [mL] or more) of blood within 60 days prior to Screening.
8. Alcohol or drug use disorder within the past 2 years
9. Current smoker/vaper or individuals who have given up smoking within the past 6 months of Screening, and/or those with >20 pack-year smoking history.
10. Current opiate/opioid use or medical history of opiate/opioid use disorder.
11. History of concurrent malignancy or recurrence of malignancy in the last 2 years
12. Body Mass Index (BMI) of ≥40 kg/m2
13. Positive results for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus
14. Unable to refrain from the use of medications and treatments that can impact cough during the study.
15. Have clinically significant history or evidence of poorly controlled cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in 24-hour Coughs per hour from Baseline to Day 28 (based on VitaloJAK® Cough Counts)

Secondary endpoints 6

1. Change in Awake coughs per hour from Baseline to Day 28 (based on VitaloJAK® Cough Counts)
2. Change in the Cough Severity Visual Analog Scale (CS-VAS) from Baseline to Day 28
3. Change in the Urge to Cough Visual Analog Scale (UC-VAS) from Baseline to Day 28
4. Change in the Leicester Cough Questionnaire (LCQ) from Baseline to Day 28
5. Patient Global Impressions of Improvement (PGI-I) score at Day 28
6. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Investigational products

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

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Nocion Therapeutics Inc.

Sponsor organisation

Nocion Therapeutics Inc.

Address

15 Main Street Suite 247

City

Watertown

Postcode

02472-4403

Country

United States

Scientific contact point

Organisation

Nocion Therapeutics Inc.

Contact name

Nocion Clinical Trials

Public contact point

Organisation

Nocion Therapeutics Inc.

Contact name

Nocion Clinical Trials

Third parties 13

Locations

3 EU/EEA countries · 22 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 149 files

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

Application history

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