A Study to Investigate MBS2320 in Patients With IPF

• Sponsor: Modern Biosciences Ltd (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05951296
• Collaborator: (none)
• Enrollment: 150
• Locations: 60
• Arms: 2
• Anticipated Duration (Months): 14.1
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

To compare the effect of daily oral dosing of MBS2320 over 12 weeks with placebo in participants aged 40 years or older with idiopathic pulmonary fibrosis (IPF).

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Drug: MBS2320; Drug: Placebo	Phase 2

Detailed Description

This will be a Phase 2, double-blind, placebo-controlled, 2-arm, parallel-group, multi-center study to investigate MBS2320 treatment of patients aged 40 years or older with IPF. The study is planned to consist of the following parts:

Screening period: 1 to 28 days (Weeks -4 to -1). Treatment period: a 12-week blinded, placebo-controlled treatment period (Weeks 1 to 12).

Follow up period: 56 days (Weeks 13 to 20). All participants will return for a follow-up visit 56 days after their final dose.

Randomization will be stratified by concomitant use of an approved anti-fibrotic drug (nintedanib or pirfenidone) at randomization versus no concomitant use of an approved anti-fibrotic drug at randomization.

Number of Participants: Approximately 150 participants will be enrolled and randomly assigned in a 2:1 ratio to receive either MBS2320 or matched placebo.

If the participant is receiving nintedanib or pirfenidone treatment, it should be stable for at least 8 weeks prior to study entry and be predicted to remain stable during the course of the study. The maximum duration of participation (including screening period and follow-up) is 24 weeks.

Data Monitoring/Other Committee: A DSMB has been appointed for this study.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Efficacy and Safety of MBS2320 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MBS2320 MBS2320 once daily	Drug: MBS2320; Drug: MBS2320
Placebo Comparator: Placebo Placebo comparator	Drug: Placebo; Placebo comparator

Outcome Measures

Primary Outcome Measures

1. Forced vital capacity (FVC) [12 weeks]

   Change from baseline in FVC versus placebo up to Week 12

Secondary Outcome Measures

1. % predicted FVC [12 Weeks]

   Change from baseline in %FVC up to Week 12

2. %DLCO [12 Weeks]

   Change from baseline in %DLCO up to Week 12

3. Acute exacerbations [12 Weeks]

   Time to first acute exacerbation up to Week 12.

4. Forced expiratory volume [12 Weeks]

   Forced expiratory volume in 1 second (FEV1)

5. Disease progression [12 Weeks]

   Decline in %FVC ≥10%, decline in %DLCO ≥15%, lung transplantation, or death.

Other Outcome Measures

1. biomarkers in serum and plasma [12 Weeks]

   hsCRP

2. Plasma pharmacokinetics [12 Weeks]

   Plasma concentrations in ng/ml

3. Adverse effects [12 Weeks]

   Incidence and frequency of treatment-emergent adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Diagnosis of IPF based on: a. ATS/ERS/JRS/ALAT guidelines (Raghu, 2022) as confirmed by the investigator based on chest high-resolution computed tomography (hrCT) scan taken within 3 years of Screening and, if available, surgical lung biopsy b. UIP or probable UIP hrCT pattern consistent with the clinical diagnosis of IPF, as confirmed by central review prior to baseline (if indeterminate, hrCT findings of IPF may be confirmed locally by historical biopsy).

2. Has an FVC ≥45% of predicted.

3. Has a DLCO corrected for hemoglobin ≥25% and ≤80% of predicted.

4. Minimum distance on 6MWT of 150 meters.

5. Has a FEV1/FVC ratio >0.70.

6. If on anti-fibrotics, only the approved treatments of nintedanib or pirfenidone are allowed. Participants must be on a stable dose for at least 8 weeks prior to Visit 1

7. Has a life expectancy of at least 12 months (in the opinion of the investigator).

• This list contains only key inclusion criteria.

Exclusion Criteria:

1. Emphysema ≥50% on hrCT or the extent of emphysema is greater than the extent of fibrosis according to the central reviewer's assessment from the most recent hrCT or if reported by the local reviewer.

2. Any current malignancy or a history of malignancy within the previous 5 years prior to screening, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.

3. Abnormality in heart rate, blood pressure or 12-lead ECG at screening that in the opinion of the Investigator increases the risk of participating in the study.

4. Significant history of drug allergy, including to MBS2320 or excipients, as determined by the Investigator.

5. Allergic reaction, anaphylaxis, or other reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis or leukopenia)

6. History of opportunistic, chronic, or recurrent infections.

7. Participants with chronic obstructive pulmonary disease (COPD) or asthma that:

• require >2 maintenance therapies

• have experienced an exacerbation requiring hospitalization or systemic corticosteroids within 12 months prior to screening.

• This list contains only key exclusion criteria.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF Fresno	Fresno	California	United States	93701-2302
2	University of California, San Francisco Medical Center	San Francisco	California	United States	94143-2204
3	National Jewish Health Main Campus	Denver	Colorado	United States	80206-2761
4	MedStar Georgetown University Hospital	Washington	District of Columbia	United States	20007
5	US Associates in Research Inc	Miami	Florida	United States	33175
6	GCP Clinical Research	Tampa	Florida	United States	33609-3589
7	Southern Medical Research, LLC	Macon	Georgia	United States	31201-8334
8	IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine	Muncie	Indiana	United States	47303-3432
9	Benchmark Research - Covington - HyperCore - PPDS	Covington	Louisiana	United States	70433-2353
10	University of Maryland Medical Center	Baltimore	Maryland	United States	21201-1544
11	Howard County Center for Lung and Sleep Medicine, LLC	Columbia	Maryland	United States	21044-3081
12	Reliant Medical Research	Worcester	Massachusetts	United States	01605-2058
13	Hudson County Clinical Trials Research Center	Union City	New Jersey	United States	07087-3375
14	Lovelace Scientific Resources Inc	Albuquerque	New Mexico	United States	87108-5129
15	Duke University Medical Center	Durham	North Carolina	United States	27710-4000
16	Southeastern Research Center	Winston-Salem	North Carolina	United States	27103-4029
17	Medical University of South Carolina - PPDS	Charleston	South Carolina	United States	29425-8900
18	Clinical Trials Center of Middle Tennessee	Franklin	Tennessee	United States	37067-5663
19	Baylor Scott and White Health - Advanced Lung Disease Specialists - Dallas	Dallas	Texas	United States	75246-2073
20	University of Utah - PPDS	Salt Lake City	Utah	United States	84108-1257
21	Hopital Avicenne	Bobigny		France
22	Hopital Nord AP-HM	Marseille		France
23	Hôpital Pasteur II	Nice		France
24	Hôpital Européen Georges Pompidou	Paris		France
25	Hopital Robert Schuman	Vantoux		France
26	Zentralklinik Bad Berka GmbH	Bad Berka		Germany
27	Ruhrlandklinik	Essen		Germany
28	IKF Pneumologie	Frankfurt am Main		Germany
29	Klinikum der Johann-Wolfgang Goethe-Universitat	Frankfurt am Main		Germany
30	Universitätsklinikum Gießen und Marburg GmbH	Gießen		Germany
31	Universitatsklinikum Halle (Saale)	Halle		Germany
32	Klinikum Köln-Merheim	Köln		Germany
33	Universitatsklinikum Leipzig	Leipzig		Germany
34	Universitatsklinikum Schleswig-Holstein - Kiel	Lübeck		Germany
35	University Hospital of Alexandroupolis	Alexandroupoli		Greece
36	Evangelismos General Hospital of Athens	Athens		Greece
37	Sotiria Chest Hospital of Athens	Athens		Greece
38	University General Hospital of Heraklion	Heraklion		Greece
39	University General Hospital of Ioannina	Ioánnina		Greece
40	University General Hospital of Larissa	Larisa		Greece
41	Georgios Papanikolaou General Hospital of Thessaloniki	Thessaloníki		Greece
42	Semmelweis Egyetem	Budapest		Hungary
43	Mátrai Gyógyintézet	Gyöngyös		Hungary
44	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Székesfehérvár		Hungary
45	Shamir Medical Center Assaf Harofeh	Be'er Ya'aqov		Israel
46	Lady Davis Carmel Medical Center	Haifa		Israel
47	Rambam Medical Center - PPDS	Haifa		Israel
48	Kaplan Medical Center	Reẖovot		Israel
49	Tel Aviv Sourasky Medical Center - PPDS	Tel Aviv-Yafo		Israel
50	Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele	Catania		Italy
51	Azienda Ospedaliera Universitaria Careggi	Firenze		Italy
52	Azienda Ospedaliero Universitaria Di Modena Policlinico	Modena		Italy
53	Fondazione Policlinico Universitario A Gemelli-Rome	Roma		Italy
54	Azienda Ospedaliera Universitaria Senese	Siena		Italy
55	Hospital Puerta del Mar	Cadiz		Spain
56	Hospital Clinico Universitario de Valencia	Valencia		Spain
57	Royal Brompton Hospital	London		United Kingdom
58	University College Hospital	London		United Kingdom
59	North Manchester General Hospital - PPDS	Manchester		United Kingdom
60	Walsall Manor Hospital	Walsall		United Kingdom

Sponsors and Collaborators

• Modern Biosciences Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Modern Biosciences Ltd
• ClinicalTrials.gov Identifier: NCT05951296
• Other Study ID Numbers: IST-07; 2023-504418-30
• First Posted: Jul 19, 2023
• Last Update Posted: Jul 19, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Modern Biosciences Ltd: IPF
• Additional relevant MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis

Study Results

No Results Posted as of Jul 19, 2023