Effects of Anti-TSLP in Patients With Asthma

• Status: Completed
• Trial end date: 2019-10-07
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether anti-TSLP will decrease airway hyperresponsiveness in patients with asthma already on daily treatment with inhaled corticosteroids.

The investigators expect that airway hyperresponsiveness will decrease after treatment with anti-TSLP, and that this happens due to a change in the type of mast cells with in the lungs. Also, the investigators expect a decrease in inflammatory cells and mediators measured in material from the lungs.

Half of the participants will receive anti-TSLP (MEDI9929) on top of their regular asthma treatment, while the other half will receive placebo on top of their regular asthma treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celeste Porsbjerg
• Collaborators: Lund University; University of Copenhagen; University of Newcastle, Australia

Criteria

Inclusion Criteria:

1. Written informed consent

2. Age 18 through 75, inclusive at the time of Visit 1

3. Body mass index between 18-40 kg/m2 (both inclusive) and weight ≥ 40 kg at Visit 1.

4. A diagnosis of asthma as defined by GINA (ginasthma.org).

5. ICS (in any dose) on a daily basis for at least three months prior to Visit 1

6. A stable asthma controller regimen with ICS (±LABA) for at least 4 weeks prior to Visit 1

7. A FEV1 value of ≥ 70% at Visit 1

8. ACQ-6 > 1 (partly controlled) at Visit 1

9. PD15 to mannitol <= 315 mg at visit 1

10. Subjects must demonstrate acceptable inhaler and spirometry techniques during screening (as evaluated and in the opinion of study site staff)

11. Subjects must demonstrate ≥ 70% compliance with usual asthma controller ICS±LABA during the screening (V1 to V3).

Exclusion Criteria:

1. Current smokers or subjects with a smoking history of ≥ 10 pack years. Former smokers with < 10 pack years must have stopped for at least 6 months to be eligible.

2. Previous medical history or evidence of an uncontrolled intercurrent illness.

3. Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results.

4. Clinically relevant abnormal findings in hematology or clinical chemistry.

5. Evidence of active liver disease.

6. History of cancer.

7. Acute upper or lower respiratory infections.

8. Helminth parasitic infection.

9. Known history of active tuberculosis (TB).

10. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology.

11. A positive human immunodeficiency virus (HIV) test.

12. History of sensitivity to any component of the investigational product.

13. History of anaphylaxis to any biologic therapy.

14. History of documented immune complex disease (Type III hypersensitivity reactions) to mAb administration.

15. History of any known primary immunodeficiency disorder.

16. Oral corticosteroids.

17. Use of 5-lipoxygenase inhibitors.

18. Use of immunosuppressive medication.

19. Pregnant, breastfeeding or lactating females.

20. History of chronic alcohol or drug abuse.

21. Receipt of the Th2 cytokine inhibitor suplatast

22. Receipt of any live or attenuated vaccines.