The Effect of Anti-IL17 on Airway Hyperresponsiveness and Resistance

NCT06224634 | Recruiting

• 1 other identifier: AHR after Anti-IL-17
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This observational longitudinal cohort study aims to assess the effect of monoclonal antibodies targeting interleukin 17 (anti-IL-17) on airway hyperreactivity and airway resistance. The study involves adult participants suffering from dermatological or rheumatological illness, who are planning to start treatment with monoclonal antibodies targeting interleukin 17 as a part of the treatment of these diseases. The primary outcome of this study will be changes in airway hyperresponsiveness to methacholine challenge reported as response-dose-ratio before and after initiation of anti-IL17 treatment regardless of presence of respiratory disease. Furthermore, the potential effect of anti-IL-17 on airway resistance will be assessed using conventional spirometry for measuring changes in FEV1 and Airwave oscillometry. A reduced degree of airway hyperreactivity and airway resistance after initiating ani-IL-17 could indicate effectiveness of anti-IL-17 in asthma patients which would have to be examined further in a population of asthma patients.

Conditions

Asthma

Keywords

Asthma; Interleukin 17; ankylosing spondylitis; Psoriasis; Airway hyperresponsiveness

Outcome Measures

Primary Outcomes (1)

• Airway hyperresponsiveness

  Airway responsiveness to methacholine challenge before and after initiation of anti-IL-17 treatment reported as a dose-response-ratio

  approximately 4 months

Secondary Outcomes (1)

• Airway resistance

  approximately 4 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be adult (18 years or older) rheumatologic og dermatologic patients planning to start treatment with anti-IL-17 antibodies. Participants must not have any conditions excluding them from performing a methacholine challenge (Previous anaphylactic shock, current pregnancy, recent cardiac disease, or FEV1 below 1,5L or 60% of expected. Furthermore, patients must not have been treated with systemic corticosteroids within the past 6 weeks.

You may qualify if:

• Patients planning to start treatment with anti-IL-17 antibodies

You may not qualify if:

• Current pregnancy
• FEV1 \< 1.5L or less than 60% of predicted value expected.
• Previous anaphylactic shock or severe allergic reaction to medicine
• Uncontrolled hypertension
• Myocardial infarction or stroke within the last 3 months
• Known aortic aneurysm
• Recent eye surgery or risk of elevated intracranial pressure
• Treatment with systemic corticosteroids within 6 weeks

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Respiratory Research Unit Hvidovre Department of Respiratory Medicine, Copenhagen University Hospital

Hvidovre, Capital Region, 2650, Denmark

RECRUITING

Related Publications (13)

• Mease PJ, McInnes IB, Kirkham B, Kavanaugh A, Rahman P, van der Heijde D, Landewe R, Nash P, Pricop L, Yuan J, Richards HB, Mpofu S; FUTURE 1 Study Group. Secukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis. N Engl J Med. 2015 Oct;373(14):1329-39. doi: 10.1056/NEJMoa1412679.

  PMID: 26422723 BACKGROUND

• Ly K, Smith MP, Thibodeaux Q, Reddy V, Liao W, Bhutani T. Anti IL-17 in psoriasis. Expert Rev Clin Immunol. 2019 Nov;15(11):1185-1194. doi: 10.1080/1744666X.2020.1679625. Epub 2019 Oct 16.

  PMID: 31603358 BACKGROUND

• Al Heialy S, Gaudet M, Ramakrishnan RK, Mogas A, Salameh L, Mahboub B, Hamid Q. Contribution of IL-17 in Steroid Hyporesponsiveness in Obese Asthmatics Through Dysregulation of Glucocorticoid Receptors alpha and beta. Front Immunol. 2020 Aug 4;11:1724. doi: 10.3389/fimmu.2020.01724. eCollection 2020.

  PMID: 32849611 BACKGROUND

• Agache I, Ciobanu C, Agache C, Anghel M. Increased serum IL-17 is an independent risk factor for severe asthma. Respir Med. 2010 Aug;104(8):1131-7. doi: 10.1016/j.rmed.2010.02.018. Epub 2010 Mar 24.

  PMID: 20338742 BACKGROUND

• Peters U, Dixon AE, Forno E. Obesity and asthma. J Allergy Clin Immunol. 2018 Apr;141(4):1169-1179. doi: 10.1016/j.jaci.2018.02.004.

  PMID: 29627041 BACKGROUND

• Newcomb DC, Cephus JY, Boswell MG, Fahrenholz JM, Langley EW, Feldman AS, Zhou W, Dulek DE, Goleniewska K, Woodward KB, Sevin CM, Hamilton RG, Kolls JK, Peebles RS Jr. Estrogen and progesterone decrease let-7f microRNA expression and increase IL-23/IL-23 receptor signaling and IL-17A production in patients with severe asthma. J Allergy Clin Immunol. 2015 Oct;136(4):1025-34.e11. doi: 10.1016/j.jaci.2015.05.046. Epub 2015 Aug 1.

  PMID: 26242299 BACKGROUND

• Kim HY, Lee HJ, Chang YJ, Pichavant M, Shore SA, Fitzgerald KA, Iwakura Y, Israel E, Bolger K, Faul J, DeKruyff RH, Umetsu DT. Interleukin-17-producing innate lymphoid cells and the NLRP3 inflammasome facilitate obesity-associated airway hyperreactivity. Nat Med. 2014 Jan;20(1):54-61. doi: 10.1038/nm.3423. Epub 2013 Dec 15.

  PMID: 24336249 BACKGROUND

• Busse WW, Holgate S, Kerwin E, Chon Y, Feng J, Lin J, Lin SL. Randomized, double-blind, placebo-controlled study of brodalumab, a human anti-IL-17 receptor monoclonal antibody, in moderate to severe asthma. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1294-302. doi: 10.1164/rccm.201212-2318OC.

  PMID: 24200404 BACKGROUND

• L. K. A. Lundblad, S. Siddiqui, Y. Bossé, and R. J. Dandurand, "Applications of oscillometry in clinical research and practice," Can. J. Respir. Crit. Care, Sleep Med., vol. 5, no. 1, pp. 54-68, Jan. 2021, doi: 10.1080/24745332.2019.1649607.

  BACKGROUND

• Abdo M, Kirsten AM, von Mutius E, Kopp M, Hansen G, Rabe KF, Watz H, Trinkmann F, Bahmer T; ALLIANCE study group. Minimal clinically important difference for impulse oscillometry in adults with asthma. Eur Respir J. 2023 May 5;61(5):2201793. doi: 10.1183/13993003.01793-2022. Print 2023 May.

  PMID: 36758985 BACKGROUND

• Nicholson PJ. The updated ATS/ERS spirometry technical standards. Occup Med (Lond). 2020 May 27;70(3):146-148. doi: 10.1093/occmed/kqaa030. No abstract available.

  PMID: 32073625 BACKGROUND

• Coates AL, Wanger J, Cockcroft DW, Culver BH; Bronchoprovocation Testing Task Force: Kai-Hakon Carlsen; Diamant Z, Gauvreau G, Hall GL, Hallstrand TS, Horvath I, de Jongh FHC, Joos G, Kaminsky DA, Laube BL, Leuppi JD, Sterk PJ. ERS technical standard on bronchial challenge testing: general considerations and performance of methacholine challenge tests. Eur Respir J. 2017 May 1;49(5):1601526. doi: 10.1183/13993003.01526-2016. Print 2017 May.

  PMID: 28461290 BACKGROUND

• Parnes JR, Molfino NA, Colice G, Martin U, Corren J, Menzies-Gow A. Targeting TSLP in Asthma. J Asthma Allergy. 2022 Jun 3;15:749-765. doi: 10.2147/JAA.S275039. eCollection 2022.

  PMID: 35685846 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma

MeSH Terms

Conditions

Asthma; Spondylitis, Ankylosing; Psoriasis; Respiratory Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jonas A Baekdal, MD

  University hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas A Baekdal, MD

CONTACT

+45 60134687; jonas.aggerholm.baekdal.02@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: August 2, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 18, 2025

Record last verified: 2024-08

Locations

DK (1)