Health TrialsbyHealthPanel

Study of Inhaled ARO-RAGE in Allergen-induced Mild Asthma

ConditionAsthma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorArrowhead Pharmaceuticals

About this trial

The purpose of this study is to evaluate the impact of inhaled ARO-RAGE on the late asthmatic response (LAR) following an inhaled allergen challenge in participants with mild atopic asthma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinically stable, mild atopic asthma (FEV1 ≥70% predicted)

Established allergy confirmed by positive skin prick test at screening

Willing and able to perform lung function tests and other study-related procedures

Participants of childbearing potential must consent to use a method of highly-effective contraception in addition to a condom during the study and for at least 90 days following the end of study or last investigational product administration, whichever is later

Disqualifiers

Concomitant diagnosis of a clinically important pulmonary disease other than asthma

Use of corticosteroids, immunosuppressives, or anti-inflammatory medications that interfere with inhaled challenges or inflammation, or chronic use of any other medication for treatment of allergic asthma

History or current medical condition contraindicating methacholine challenge

Trial design

Design model

Parallel

Treatments tested in this trial

  • ARO-RAGE

    Drug

    Inhalation of nebulized solution

  • Placebo

    Drug

    Calculated volume to match active treatment by inhalation of nebulized solution

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: ARO-RAGEExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline Over Time in Maximum Area of Reactance

Time frame
Baseline through Day 58

Secondary outcomes

1

Change from Baseline Over Time in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve

Time frame
Baseline through Day 58
2

Change from Baseline Over Time in Maximum Change in Small Airway Reactance

Time frame
Baseline through Day 58
3

Number of Participants with Treatment-Emergent Adverse Events

Time frame
Up to Day 113 (End of Study)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arrowhead Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
Apply now