A Study of MRx-4DP0004 in Asthma

4D pharma

Status and phase: Terminated; Phase 1

Conditions: Asthma

Treatments: Drug: MRx-4DP0004; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03851250

MRx-4DP0004-I-001

Details and patient eligibility

About

This is a multicentre, phase I/II, double-blind, placebo-controlled study of MRx-4DP0004 in participants taking long-term medication for asthma. Participants will take two capsules of MRx-4DP0004 twice daily in addition to their existing asthma medication for 12 weeks. Safety and tolerability and immune modulatory effects of MRx-4DP0004 will be assessed throughout the study.

Enrollment: 34 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented history and diagnosis of asthma at least 6 months prior to Visit 1.
• Stable current asthma treatment as per GINA steps 2-4 (ICS with or without LABA) for at least 2 months prior to Visit 1.
• ACQ-6 score >1.5 and <=4
• FEV1 >50% of predicted normal
• Following protocol specified contraception requirements.

Exclusion criteria

• Non-compliant with prescribed asthma maintenance treatment.
• At significant risk of exposure to a change in environmental sensitising substances during the study.
• Co-morbidities not optimally controlled for the last 3 months or any co-morbidity that may put the subject at risk or influence the outcome of the study.
• Hepatitis B or C or HIV.
• GI fistula, feeding tubes or inflammatory bowel disease.
• GI disease resulting in inability for oral intake, malabsorption syndrome, surgical procedures affecting absorption, uncontrolled inflammatory bowel disease.
• History of life-threatening asthma.
• Systemic corticosteroids within 6 weeks of first dose.
• Allergy to all of ampicillin, clindamycin and imipenem.
• Probiotic supplements.
• Immunosuppression or immunosuppressant medication.
• Use of ICS and LABA as Maintenance and Reliever Therapy.
• Smokers or nicotine users within 3 months of screening.
• Former smokers >15 pack years.
• Systemic antibiotics within 6 weeks of first dose.
• Clinically significant haematology and serum biochemistry.
• Sensitivity to any constituent of IMP.
• Diastolic blood pressure <45 or >90, systolic blood pressure <95 or >155mmHg, Pulse rate <40 or >100 bpm.
• Clinically significant ECGs or structural cardiac abnormalities.
• Any other condition that may interfere with primary objective.
• Receipt of a positive COVID-19 test result within 4 weeks of first dose of IMP

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

MRx-4DP0004

Experimental group

Description:

MRx-4DP0004 is a Live Biotherapeutic Product containing 10\^9 to 10\^10 Colony Forming Units. Participants randomised to this arm will take 2 capsules twice daily at approximately 12 hour intervals for 12 weeks.

Treatment:

Drug: MRx-4DP0004

Placebo

Placebo Comparator group

Description:

Participants randomised to this arm will take 2 capsules of placebo twice daily at approximately 12 hour intervals for 12 weeks. All participants will receive placebo in a single blind manner for two weeks in addition to the 12 weeks of double blind treatment.

Treatment:

Drug: Placebo