Allergy to House Dust MitePhase 2TregulaireNCT04673591
Effects of Tregalizumab on Allergen-induced Airway Responses and Airway Inflammation in Asthmatic Patients
A Phase 2 study testing Tregalizumab in people with Allergy to House Dust Mite and Allergic Asthma, run by T-Balance Therapeutics GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergy to House Dust Mite, Allergic Asthma
- What is being tested?
- Tregalizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 9 Dec 2020to 12 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 response before and after treatment. Subjects will be randomized to two parallel treatment groups. Each subject will be treated weekly over 12 weeks either with test product or with the reference product (placebo).
- Conditions
- Allergy to House Dust Mite, Allergic Asthma
- Being tested
- Tregalizumab, Placebo
- Keywords
- Mild asthma, House Dust Mite, Allergy
- Medical subject headings
- Dust Mite Allergy, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TregalizumabDrug
a monoclonal antibody designed for the treatment of allergic asthma indication
PlaceboOther
Matched Placebo
| Study group | Role | What they receive |
|---|---|---|
| Tregalizumab | Experimental | Not described Receives: Drug: Tregalizumab |
| Matched placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline-corrected late asthmatic response measured by the area under the curve for the forced expiratory volume (FEV1) at 4 to 7 hours after bronchial allergen provocation
Measured: Day 84
Secondary outcomes (17)
Change in late asthmatic response, as measured from 4 to 7 hours after bronchial allergen provocation by the maximum decrease in the normalized forced expiratory volume (FEV1) values
Measured: Baseline and Day 84
Change in early asthmatic response, as measured from 0 to 3 hours after bronchial allergen provocation by the maximum decrease in the normalized forced expiratory volume (FEV1) values
Measured: Baseline and Day 84
Change in early asthmatic response, as measured from 0 to 3 hours after bronchial allergen provocation by the area under the curve of the normalized forced expiratory volume (FEV1) values
Measured: Baseline and Day 84
Fraction of eNO (FeNO) absolute levels and delta increase after bronchial allergen provocation
Measured: Baseline and Day 84
Dose of methacholine causing a decrease in forced expiratory volume (FEV1) of at least 20% (PD20)
Measured: Baseline, Day 85, Day 112
Impact of tregalizumab on TH1, TH2 and TH17 cytokines in blood
Measured: Baseline, Day 1, Day 85
Impact of tregalizumab on TH1, TH2 and TH17 cytokines and T-cell transcription factors in sputum
Measured: Day 1 until Day 85
Number of eosinophils, neutrophils, macrophages and lymphocytes in sputum
Measured: Day 1 until Day 85
Eosinophil cationic protein (ECP) concentration in sputum
Measured: Day 1 until Day 85
Number of eosinophils in blood
Measured: Baseline, at Day 1, Day 84 and Day 85
Change in mite-specific IgE, IgG4, total IgE and IgG levels in blood
Measured: Baseline and Day 84
Impact of tregalizumab on the expression of markers of PBMC lineage in blood
Measured: Baseline until Day 112
Incidence and severity of adverse events (AEs) in the participants
Measured: Approximatively 27 weeks (study duration)
Levels of specific anti-tregalizumab antibodies in blood
Measured: Day 1, Day 36, Day 84
Number of rescue ß2-agonist puffs used
Measured: Approximatively for 27 weeks
Change of VAS Nasal Symptom Score
Measured: Baseline and Day 84
Quality of life assessed with Asthma Control Test (ACT) and Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12)
Measured: Baseline and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start9 Dec 2020
- Primary completion12 Jan 2022
- Study completion12 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy to House Dust MiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- T-Balance Therapeutics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Zielen, Prof. Dr., Principal investigator, Medaimun GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673591
- Sponsor's protocol ID
- OG-061-01
- Acronym
- Tregulaire
- Status last verified
- Feb 2022
- First submitted
- 26 Nov 2020
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tregalizumab on Allergen-induced Airway Responses and Airway Inflammation in Asthmatic Patients
- ClinicalTrials.gov ID
- NCT04673591
- Acronym / sponsor ID
- Tregulaire / OG-061-01
- Conditions
- Allergy to House Dust Mite, Allergic Asthma
- Keywords
- Mild asthma, House Dust Mite, Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- T-Balance Therapeutics GmbHIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 response before and after treatment. Subjects will be randomized to two parallel treatment groups. Each subject will be treated weekly over 12 weeks either with test product or with the reference product (placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Tregalizumab | Experimental | Drug: Tregalizumab |
| Matched placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (34 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tregalizumaba monoclonal antibody designed for the treatment of allergic asthma indication | Drug | Tregalizumab |
| PlaceboMatched Placebo | Other | Matched placebo |
Primary outcome
Baseline-corrected late asthmatic response measured by the area under the curve for the forced expiratory volume (FEV1) at 4 to 7 hours after bronchial allergen provocation
Time frame: Day 84
17 secondary outcomes
Change in late asthmatic response, as measured from 4 to 7 hours after bronchial allergen provocation by the maximum decrease in the normalized forced expiratory volume (FEV1) values
Time frame: Baseline and Day 84
Change in early asthmatic response, as measured from 0 to 3 hours after bronchial allergen provocation by the maximum decrease in the normalized forced expiratory volume (FEV1) values
Time frame: Baseline and Day 84
Change in early asthmatic response, as measured from 0 to 3 hours after bronchial allergen provocation by the area under the curve of the normalized forced expiratory volume (FEV1) values
Time frame: Baseline and Day 84
Fraction of eNO (FeNO) absolute levels and delta increase after bronchial allergen provocation
Time frame: Baseline and Day 84
Dose of methacholine causing a decrease in forced expiratory volume (FEV1) of at least 20% (PD20)
Time frame: Baseline, Day 85, Day 112
Impact of tregalizumab on TH1, TH2 and TH17 cytokines in blood
Time frame: Baseline, Day 1, Day 85
Impact of tregalizumab on TH1, TH2 and TH17 cytokines and T-cell transcription factors in sputum
Time frame: Day 1 until Day 85
Number of eosinophils, neutrophils, macrophages and lymphocytes in sputum
Time frame: Day 1 until Day 85
Eosinophil cationic protein (ECP) concentration in sputum
Time frame: Day 1 until Day 85
Number of eosinophils in blood
Time frame: Baseline, at Day 1, Day 84 and Day 85
Change in mite-specific IgE, IgG4, total IgE and IgG levels in blood
Time frame: Baseline and Day 84
Impact of tregalizumab on the expression of markers of PBMC lineage in blood
Time frame: Baseline until Day 112
Incidence and severity of adverse events (AEs) in the participants
Time frame: Approximatively 27 weeks (study duration)
Levels of specific anti-tregalizumab antibodies in blood
Time frame: Day 1, Day 36, Day 84
Number of rescue ß2-agonist puffs used
Time frame: Approximatively for 27 weeks
Change of VAS Nasal Symptom Score
Time frame: Baseline and Day 84
Quality of life assessed with Asthma Control Test (ACT) and Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12)
Time frame: Baseline and Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
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Severe Asthma, Allergy to House Dust Mites
Not yet recruitingPhase 2/3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Zielen, Prof. Dr. principal investigator
Medaimun GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tregalizumab in people with Allergy to House Dust Mite and Allergic Asthma, run by T-Balance Therapeutics GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline-corrected late asthmatic response measured by the area under the curve for the forced expiratory volume (FEV1) at 4 to 7 hours after bronchial allergen provocation (time frame: Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.