A clinical study investigating OM-85 efficacy and safety in children suffering from Recurrent Wheezing

Overview

Sponsor-declared trial summary

Key facts

Sponsor

OM Pharma SA

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

3 Oct 2024 → ongoing

Decision date (initial)

2024-07-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

OM Pharma SA

External identifiers

EU CT number

2024-511083-90-00

ClinicalTrials.gov

NCT05857930

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To assess the efficacy of OM-85 in reducing the rate of WEs vs. placebo during the 6month Treatment period in children aged 6 months to 5 years with previous recurrent WEs

Secondary objectives 4

1. To assess the efficacy of OM-85 in reducing the rate of severe WEs vs. placebo during the 6month Treatment period.
2. To assess the efficacy of OM-85 in reducing the use of oral corticosteroids for WEs vs. placebo during the 6month Treatment period.
3. To assess the efficacy of OM-85 to decrease the cumulative number of days with WEs vs. placebo during the 6month Treatment period.
4. Safety objective: To assess the safety of daily OM-85 treatment vs. placebo in children aged 6 months to 5 years with recurrent WEs during the 6-month Treatment period, during the 6-month Observational period and during the Whole study period.

Conditions and MedDRA coding

Recurrent wheezing

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Children of either gender, aged between 6 and 72 months (5 years inclusive).
2. Children with recurrent wheezing: a. For ICS/LTRA naïve patients or intermittent users: ≥2 WEs including at least 1 severe episode (i.e., treated with OCS OR having triggered an ED visit/hospitalization), OR ≥3 WEs including one that triggered an unscheduled physician visit, as reported by parents or LAR of subject, in the 12 months prior to enrollment. b. For ICS/LTRA daily users: ≥1 severe WE (i.e., treated with OCS or having triggered an ED visit/hospitalization) OR ≥2 WEs including one that triggered an unscheduled physician visit, as reported by parents or LAR of subject (i.e., guardians), in the 12 months prior to enrollment, while being on their daily controller therapy. Note: While WE counted for enrollment are based on parent reporting, the PI must ensure that they fulfill the WE definition of the protocol.
3. Up-to-date vaccination status as per applicable State Or Country Vaccination Requirements for school/daycare entry.
4. Parents or LAR have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures.

Exclusion criteria 16

1. Known anatomic alterations of the respiratory tract.
2. Wheezing documented to be caused by gastroesophageal reflux.
3. Other known chronic respiratory diseases (e.g., tuberculosis or cystic fibrosis).
4. Any known autoimmune disease.
5. Known HIV infection or any known type of congenital or iatrogenic immune deficiency (including IgA deficiency).
6. Known acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal function abnormalities.
7. Children born prematurely, i.e., before 34 weeks of gestational age.
8. Children with an abnormally low or high weight for their age and height, if in the opinion of the Investigator, this would not allow safe completion of the clinical study.
9. Any known neoplasia or malignancy.
10. Treatment with the following medications: a. Systemic (intravenous or intramuscular) or oral corticosteroids or OCS (e.g., oral prednisolone) within 4 weeks before study enrollment. b. Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months before study enrollment.
11. Any major surgery within the last 3 months prior to study enrollment or planned during the study duration.
12. Known allergy or previous intolerance to investigational drug.
13. Any other clinical conditions, which in the opinion of the Investigator, would not allow safe completion of the clinical study.
14. Other household members have previously been randomized in this clinical study.
15. Inability to comply with the study requested visit schedule (e.g., expected relocation within 12 months of the screening for the study).
16. Currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening or receiving other investigational agent(s).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Rate of wheezing/asthma-like episodes (WEs) during the 6 months of the Treatment period, defined as the number of WEs experienced by a subject during the 6month Treatment period.

Secondary endpoints 4

1. Rate of severe WEs during the 6month Treatment period.
2. Rate of WE requiring OCS treatment during the 6-month Treatment period.
3. Number of days with wheezing/asthma-like symptoms during the 6month Treatment period.
4. Safety, including AEs, SAEs, vital signs, and physical examination.

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

OM Pharma SA

Sponsor organisation

OM Pharma SA

Address

Rue Du Bois-Du-Lan 22

City

Meyrin

Postcode

1217

Country

Switzerland

Scientific contact point

Organisation

OM Pharma SA

Contact name

Clinical Development Department

Public contact point

Organisation

OM Pharma SA

Contact name

Clinical Development Department

Third parties 12

Locations

2 EU/EEA countries · 6 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 23 files

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

Application history

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