Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA)

NCT07600190 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 25-1995R34HL179910
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this single center, interventional pilot study, 40 participants at high risk for future exacerbation will be randomized to anakinra (v. placebo control) treatment for home administration as part of an asthma action plan (AAP) and monitored through their first moderate asthma exacerbation, triggering treatment dosing over a 26 week period. Key feasibility questions will be assessed in this pilot study to inform trial design and sample size selection for a future multi-site phase II clinical trial testing anakinra as a rescue treatment for moderate asthma exacerbations.

Conditions

Asthma (Diagnosis); Persistent Asthma; Moderate Asthma Exacerbation

Keywords

Asthma; Asthma Exacerbation; Anakinra; Kineret; Interleukin-1 Receptor Antagonist; IL-1 receptor blockade; Airway Inflammation; Persistent Asthma

Outcome Measures

Primary Outcomes (2)

• Effect of Anakinra on percent change in Peak Expiratory Flow from baseline during moderate asthma exacerbation

  Area under the curve (AUC) of percent change in morning peak expiratory flow (PEF) from baseline, over the period of treatment day 1 through 10 days post-treatment day 1, calculated using the trapezoidal method, and comparing Anakinra to placebo treatment.

  Day 1 of treatment through day 10 after treatment

• Study Design Feasibility - Percentage of participants who experience one moderate asthma exacerbation

  Percent of randomized participants who experience one moderate asthma exacerbation (as defined by the participant's asthma action plan) during the 6-month study period.

  The 6-month period from randomization to the end of study visit

Secondary Outcomes (14)

• Effect of Anakinra on Asthma Index during moderate asthma exacerbation

  Day 1 of treatment to day 10 after treatment

• Intervention Feasibility - Mean number of participants enrolled per month

  18 months

• Intervention Feasibility - Mean number of participants randomized per month

  18 months

• Intervention Feasibility - Percentage of participants retained through completion of study

  24 months

• Study Design Feasibility - Percentage of participants completing daily PEF measurements

  24 months

Study Arms (2)

Active Treatment

ACTIVE COMPARATOR

Subjects will be randomized to receive two doses of active study treatment (anakinra) upon meeting orange zone exacerbation criteria.

Drug: Anakinra 100 Mg/0.67 Ml Inj Syringe

Placebo

PLACEBO COMPARATOR

Subjects will be randomized to receive two doses of placebo upon meeting orange zone exacerbation criteria.

Drug: Saline Placebo/0.67 Ml Inj Syringe

Interventions

Anakinra 100 Mg/0.67 Ml Inj Syringe DRUG

Active study treatment

Active Treatment

Saline Placebo/0.67 Ml Inj Syringe DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Age ≥18 years
• A history of physician-diagnosed persistent asthma or symptoms consistent with persistent asthma based on national or international guidelines for diagnosis and management of asthma.
• Current use of controller therapy such as inhaled corticosteroid (ICS) or ICS in combination with long-acting beta agonist (LABA)
• Asthma exacerbation requiring systemic corticosteroid therapy in the past 12 months
• Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy or who have been amenorrheic for 12 months or more.
• Asthma Impairment and Risk Questionnaire (AIRQ) Score \>2

You may not qualify if:

• Clinical contraindications:
• Physician diagnosis of other chronic pulmonary disease including cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema or congenital disorders of the lungs or airways.
• History of undergoing bronchial thermoplasty.
• Intubation for asthma in the last 12 months
• History of malignancy except non-melanoma skin cancer within the last five years.
• Mental illness or history of substance abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
• History of smoking: i. Smoking \>1 time per week in the past year; ii. If ≥40 years old: Smoked ≥15 pack years; iii. If \<40 years old: Smoked ≥10 pack years; iv. Smoking equivalents of 1 pack cigarettes a day for 1 year: 1 cigar or pipe daily for 1 year; Hookah - 1 session per day for 1 year; E-cigarettes or vapes - 1 cartridge/tank/pod per day for 1 year; and active use of smoking/vaping marijuana, specified as once per week in the last year.
• Allergy/sensitivity to study drugs or their formulations, including latex
• Unwillingness to use reliable contraception if sexually active (IUD, birth control pills/patch, condoms).
• Current participation in an interventional trial in which study administration was administered within the past 60 days or within 5 half-lives of the drug (whichever is greater)
• Pregnancy, plans to get pregnant or nursing a baby. Female volunteers will be asked to use effective birth control (stable regimen of hormonal contraceptive use for at least 6 months, intrauterine device placement, or tubal ligation for at least 6 months through at least one week after study completion) and will provide a urine sample to test for pregnancy on study days. If the test is positive or the participant has reason to believe she may be pregnant, she will be dismissed from the study. Women who have been amenorrheic for 12 months may participate. Male volunteers will be asked to use condoms for the duration of the study through at least one week after study completion.
• Usage of the following medications:
• Use of daily systemic corticosteroid therapy for asthma control
• Use of any immunomodulatory therapy within the preceding 12 months, including biologics that are approved for asthma.
• Currently receiving allergen immunotherapy

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Asthma; Disease

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Michelle Hernandez, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Brooks

CONTACT

919-843-6598; chris_brooks@med.unc.edu

Corinne Taylor

CONTACT

919-962-9841; corinne.lawler@unc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be allocated to placebo or anakinra treatment using permuted block randomization with a block of size 4 (2 placebo, 2 anakinra)

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 9 and continuing for 36 months following publication.
• Access Criteria: Investigators with approved IRB, IEC, or REB for use of the requested data and who have executed a data use/sharing agreement with UNC.

Locations

US (1)