Status:
COMPLETED
Effects of Tregalizumab on Allergen-induced Airway Responses and Airway Inflammation in Asthmatic Patients
Lead Sponsor:
T-Balance Therapeutics GmbH
Conditions:
Allergy to House Dust Mite
Allergic Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The study will be conducted as a randomized, double-blind, placebo-controlled, single-center study in adult patients with mild controlled allergic asthma and house dust mite allergy.
Detailed Description
This study will consist of a screening phase, a treatment phase and a follow-up phase. Eligible subjects will undergo a bronchial allergen provocation (BAP) with mite allergen to assess the asthmatic...
Eligibility Criteria
Inclusion
- Willing and able to give written informed consent.
- Male or female subject aged 18 to 65 years (both inclusive).
- Established diagnosis of mild controlled allergic asthma (GINA 2019) and history of allergic bronchial asthma for at least 1 year.
- BMI of 18.0 to 30.0 (both inclusive).
- Non-smoker (all substances).
- Specific IgE to HDM (Dermatophagoides farinae) ≥ class 2 in radioallergosorbent test (RAST).
- BHR (i.e., a decrease in FEV1 of at least 20%) measured by methacholine challenge.
- FEV1 ≥ 75% of predicted value (according to height, weight and sex).
- Subject must demonstrate a significant EAR and LAR without rescue medication use within the first 7 hours after BAP.
- No clinically relevant abnormalities in 12-lead ECG at screening.
Exclusion
- Severe, unstable bronchial asthma.
- Exacerbation of asthma ≤ 4 weeks prior to screening.
- Treatment with parenteral and oral corticosteroids 6 weeks prior to screening and during the study.
- Treatment with inhaled corticosteroids, methylxanthines (e.g., theophyllin), anticholinergics (e.g., ipratropium bromide), leukotriene modifiers (e.g., montelukast), tiotropium bromide, cromolyn or nedocromil within 2 weeks prior to screening and during the study.
- Current treatment with any immunosuppressants (e.g., monoclonal antibodies, methotrexate, cyclosporin).
- Specific immunotherapy (SCIT) to mite within 3 years prior to screening.
- Serious adverse drug reaction to previous biological treatment.
- Previous therapy with a mAb targeting CD4, including tregalizumab.
- Known hypersensitivity to any constituents of tregalizumab and/or other mAbs, that, in the opinion of the investigator or Medical Monitor, contraindicates participation.
- Previous inclusion in this study.
- Serum transaminases, ALAT and/or ASAT \> 2.5-fold ULN at screening.
- Bilirubin \> 34.2 µmol/L at screening.
- AP \> 2-fold ULN at screening.
- Urea nitrogen \> 1.5-fold ULN at screening.
- Kidney insufficiency as defined by creatinine level \> 133 µmol/L at screening.
- History of severe allergic or anaphylactic reaction to proteins of human origin (e.g. vaccination reaction, biological therapy).
- Presence or history of malignancy within the previous 5 years (except completely resected squamous or basal cell carcinoma of the skin).
- Presence or history of clinically significant major disease (e.g., severe heart/lung disease New York Heart Association \[NYHA\] Class ≥ 3, autoimmune disease \[apart from rheumatoid arthritis\], acute uncontrolled hyper- or hypo-thyroidism, severe uncontrolled hypo or hypertension).
- Serious local (e.g., abscess) or systemic (e.g., pneumonia, septicemia) infection or recurrent chronic infections within 6 weeks prior to screening visit or during the screening period.
- Any infection requiring antibiotic therapy by any route of administration within 4 weeks prior to screening.
- Vaccination with live, live attenuated, and/or killed vaccines in the 12 weeks prior to the first administration of the study drug and during the study.
- Positive diagnosis for acute or chronic infections (e.g. HCV, HBV, HIV) at screening or history of previous chronic infection.
- Acute or clinically symptomatic EBV (infectious mononucleosis) or CMV infection.
- Presence or history of latent or active tuberculosis.
- Known immune deficiency.
- Presence or history of lymphoproliferative disease, including lymphoma and lymphadenopathy.
- Presence or history of clinically significant drug or alcohol abuse.
- Employee at study site or any institution involved in this study (including the sponsor), or spouse/partner or relative of an investigator.
- Pregnant or nursing woman or woman considering to become pregnant during the study or in the 3 months after the last administration of study drug.
- Woman of childbearing potential (unless surgically sterile or post-menopausal \> 52 weeks) who is not using two (2) independent effective contraceptive methods (e.g., oral or injectable contraceptives, intra-uterine devices, double barrier method, contraceptive patch or female sterilization) during the study and for at least 3 months after the last administration of study drug OR Non-vasectomized man who, during the study or in the 3 months after the last administration of study drug, is not using two (2) independent effective contraceptive methods (as specified above) or is planning a sperm donation.
- Donation of blood within 30 days prior to screening until end of study.
- Participation in another clinical trial within 90 days before screening or during the study.
- Inability or lacking motivation to adhere to the study requirements and to comply with the study schedule.
- Imprisonment or placement in an institution (AMG § 40 (1), sentence 4).
Key Trial Info
Start Date :
December 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04673591
Start Date
December 9 2020
End Date
January 12 2022
Last Update
February 8 2022
Active Locations (1)
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1
Medaimun GmbH
Frankfurt, Germany