A study to Assess the Efficacy and Safety of Namilumab in subjects with lung inflammatory disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Kinevant Sciences GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

21 Nov 2022 → 9 Apr 2025

Decision date (initial)

2024-04-05

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Kinevant Sciences GmbH

External identifiers

EU CT number

2024-511115-25-00

EudraCT number

2021-004794-31

WHO UTN

U1111-1302-2991

ClinicalTrials.gov

NCT05314517

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety

To evaluate the effect of namilumab on the need for rescue treatment for worsening of sarcoidosis.

Secondary objectives 5

1. To evaluate the effect of namilumab on percent predicted forced vital capacity (ppFVC);
2. To evaluate the effect of namilumab on the time to the first rescue event;
3. To evaluate the effect of namilumab on proportion of subjects achieving OCS taper without rescue event;
4. To assess the effect of namilumab on respiratory symptoms based on the King's Sarcoidosis Questionnaire (KSQ) Lung domain;
5. To assess the safety and tolerability of namilumab;

Conditions and MedDRA coding

chronic pulmonary sarcoidosis

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

EMA paediatric investigation plan (PIP)

EMEA-003275-PIP01-22

Plan to share IPD

No

IPD plan description

NAP

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male or female age ≥18 years
2. Able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form
3. Greater than or equal to 6-month history of documented sarcoidosis including histological confirmation in the subject's medical records
4. Evidence of sarcoidosis as indicated by: a) HRCT consistent with Pulmonary Sarcoidosis AND; b) Medical Research Council Dyspnea scale >1 (i.e., Grade 2 or more) AND; c) One or more of the following is present: i) Screening FDG-PET consistent with pulmonary sarcoidosis AND SUVmax ≥ 3; ii) Recent history of worsening sarcoidosis; iii) Recent history that tapering OCS and/or ISTs resulted in an increase of pulmonary disease
5. Body Mass Index (BMI) ≤ 40 kg/m2 at Screening
6. Vaccinations for COVID-19 with completion of the primary series at least 2 weeks prior to randomization

Exclusion criteria 11

1. Hospitalized for any respiratory illness ≤ 30 days prior to or during Screening
2. Greater than or equal to 20% fibrosis as indicated on HRCT-scan assessed by central read prior to randomization
3. Hemoglobin ≤ 9.5 g/dL
4. Participation in another interventional clinical trial (IP/Device) within 6 months prior to Screening, during screening and throughout the duration of the study
5. ECG abnormalities that warrant further clinical investigation or management at Screening
6. Systolic blood pressure (SBP) <90 or >180mm Hg; Diastolic blood pressure (DBP) <60 or >110 mm Hg at Screening
7. Has documented laboratory-confirmed SARS-CoV-2 infection with pulmonary involvement or signs/symptoms of long COVID as determined by approved testing ≤ 6 months prior to randomization
8. Other significant pulmonary disease or conditions that prevent subject from performing acceptable spirometry
9. Females who are pregnant or breastfeeding or intend to be during the course of the study
10. Any other acute or chronic medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the Investigator or Sponsor, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results, and would make the participant inappropriate for entry into this study
11. Subjects who are treatment naive

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of subjects with a rescue event during DB period.

Secondary endpoints 5

1. Change from baseline in percent predicted forced vital capacity (ppFVC) at Week 26;
2. Time to first rescue event during DB period;
3. Proportion of subjects successfully achieving OCS taper without rescue event during DB period;
4. Change from baseline in the KSQ Lung domain score at Week 26;
5. Safety and tolerability, including assessment of physical examinations (PEs), vital signs, electrocardiograms (ECGs), clinical laboratory measurements, and AEs during DB period;

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Kinevant Sciences GmbH

Sponsor organisation

Kinevant Sciences GmbH

Address

Viaduktstrasse 8

City

Basel

Postcode

4051

Country

Switzerland

Scientific contact point

Organisation

Kinevant Sciences GmbH

Contact name

Clinical Development Lead

Public contact point

Organisation

Kinevant Sciences GmbH

Contact name

Head of Patient Advocacy

Third parties 1

Locations

4 EU/EEA countries · 11 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 4 · Art. 38 CTR

Results and documents

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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 5 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