A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations (Levante)

A Phase 2b, Randomised, Double-Blind, Placebo-Controlled Dose Range-Finding Study to Assess Efficacy and Safety of Multiple Dose Levels of Inhaled AZD8630 Given Once Daily for 12 Weeks in Adults With Uncontrolled Asthma at Risk of Exacerbations (LEVANTE)

A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with uncontrolled asthma at risk of exacerbations, receiving medium -to -high dose inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA).

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: AZD8630; Device: Inhaler; Drug: Placebo

Detailed Description

This is a Phase II, randomised, placebo-controlled, double-blind, dose range-finding, multi-centre study to assess the efficacy and safety of inhaled AZD8630 administered at 3 doses via an inhaler in adult patients with uncontrolled asthma, at risk of an exacerbation. The study duration up to 57 weeks for participants in the optional safety extension study and up to 17 weeks for those not included. The maximal treatment period is up to 52 weeks.

This study will be conducted in approximately 220 centres in 20-25 countries. Approximately 516 patients will be randomised globally

• Study Type: Interventional
• Enrollment (Actual): 537
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Alberdi, Argentina, X5033DCE
    • Research Site
  • CABA, Argentina, C1426
    • Research Site
  • Capital Federal, Argentina, C1060ABN
    • Research Site
  • Mar del Plata, Argentina, 7600
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  • Quilmes, Argentina, B1878FNR
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  • Rosario, Argentina, 2000
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  • San Fernando, Argentina, B1646EBJ
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  • San Juan Bautista, Argentina, 1888
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  • San Miguel de Tucumán, Argentina, 4000
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• Belgium
  • Duffel, Belgium, 2570
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  • Mechelen, Belgium, 2800
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  • Namur, Belgium, 5101
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• Chile
  • Chile, Chile, 7770484
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  • Curicó, Chile, 3341643
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  • Santiago, Chile, 7500691
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  • Santiago, Chile, 7500587
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  • Talca, Chile, 3465584
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  • Viña del Mar, Chile, 2540488
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• China
  • Baotou, China, 014010
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  • Changchun, China, 130021
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  • Chengdu, China, 610078
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  • Chongqing, China, 401320
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  • Guangzhou, China, 510163
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  • Guiyang, China, 510630
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  • Hefei, China, 230061
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  • Hohhot, China, 010010
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  • Jinan, China, 250021
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  • Lanzhou, China, 730000
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  • Nanchang, China, 330006
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  • Ningbo, China, 315010
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  • Qingdao, China, 266011
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  • Shanghai, China, 200080
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  • Shenyang, China, 110004
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  • Shijiazhuang, China, 050051
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  • Taiyuan, China, 030032
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  • Wenzhou, China, 325027
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  • Xuzhou, China, 221000
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• Czechia
  • Brno, Czechia, 62500
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  • Hradec Králové, Czechia, 50005
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  • Jindřichův Hradec, Czechia, 377 01
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  • Kralupy nad Vltavou, Czechia, 278 01
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  • Pilsen, Czechia, 32300
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  • Prague, Czechia, 15300
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  • Teplice, Czechia, 415 01
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  • Varnsdorf, Czechia, 407 47
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• Denmark
  • Aalborg, Denmark, 9100
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  • Hvidovre, Denmark, 2650
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  • København NV, Denmark, 2400
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  • Odense, Denmark, 5000
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  • Roskilde, Denmark, 4000
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  • Vejle, Denmark, 7100
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• France
  • Lyon, France, 69317
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  • Marseille, France, 13915
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  • Nice, France, F-06002
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  • Paris, France, 75018
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  • Reims, France, 51092
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• Germany
  • Berlin, Germany, 10119
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  • Bonn, Germany, 53127
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  • Essen, Germany, 45239
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  • Frankfurt, Germany, 60596
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  • Landsberg, Germany, 86899
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  • Leipzig, Germany, 04207
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  • Mainz, Germany, 55128
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  • Marburg, Germany, 35037
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• Hong Kong
  • Hong Kong, Hong Kong
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• Israel
  • Ashkelon, Israel, 78278
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  • Jerusalem, Israel, 9372212
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  • Rehovot, Israel, 76100
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  • Tel Aviv, Israel, 6423906
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• Italy
  • Genoa, Italy, 16132
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  • Milan, Italy, 20122
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  • Roma, Italy, 00168
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  • Roma, Italy, 161
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• Japan
  • Chūōku, Japan, 104-0031
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  • Fukuoka, Japan, 819-8555
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  • Hiratsuka-shi, Japan, 254-8502
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  • Hiroshima, Japan, 730-0013
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  • Kitakyushu, Japan, 802-0052
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  • Kusatsu-shi, Japan, 525-8585
    • Research Site
  • Maebashi, Japan, 371-0048
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  • Maebashi, Japan, 371-0054
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  • Meguro-ku, Japan, 153-8515
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  • Mizunami-shi, Japan, 509-6134
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  • Nankoku-shi, Japan, 783-8509
    • Research Site
  • Niigata, Japan, 950-1197
    • Research Site
  • Sakaishi, Japan, 591-8555
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  • Sapporo, Japan, 064-0804
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  • Shinjuku-ku, Japan, 162-8655
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  • Toyoake-shi, Japan, 470-1192
    • Research Site
  • Yanagawa-shi, Japan, 832-0059
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  • Yokohama, Japan, 236-0037
    • Research Site
• Mexico
  • Durango, Mexico, 34200
    • Research Site
  • Guadalajara, Mexico, 44130
    • Research Site
  • Monterrey, Mexico, 64710
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  • Monterrey, Mexico, 64040
    • Research Site
  • Villahermosa, Mexico, 86035
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• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • Research Site
  • Amersfoort, Netherlands, 3813 TZ
    • Research Site
• Slovakia
  • Kežmarok, Slovakia, 060 01
    • Research Site
  • Košice, Slovakia, 04022
    • Research Site
  • Levice, Slovakia, 93401
    • Research Site
  • Prešov, Slovakia, 081 81
    • Research Site
  • Topoľčany, Slovakia, 95501
    • Research Site
  • Topoľčany, Slovakia, 955 01
    • Research Site
  • Žilina, Slovakia, 010 01
    • Research Site
• South Africa
  • Cape Town, South Africa, 7700
    • Research Site
  • Durban, South Africa, 4001
    • Research Site
  • Observatory, South Africa, 7925
    • Research Site
  • Somerset West, South Africa, 7130
    • Research Site
  • Tygervalley, South Africa, 7530
    • Research Site
  • eMkhomazi, South Africa, 4170
    • Research Site
• South Korea
  • Daegu, South Korea, 42415
    • Research Site
  • Seoul, South Korea, 06591
    • Research Site
  • Seoul, South Korea, 03312
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  • Seoul, South Korea, 5505
    • Research Site
  • Seoul, South Korea, 3722
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• Spain
  • Barcelona, Spain, 8035
    • Research Site
  • Benalmádena, Spain, 29631
    • Research Site
  • Madrid, Spain, 28041
    • Research Site
  • Majadahonda, Spain, 28222
    • Research Site
  • Málaga, Spain, 29010
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  • Palma de Mallorca, Spain, 07010
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  • Santander, Spain, 39008
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  • Valencia, Spain, 46010
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• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Research Site
  • Taichung, Taiwan, 40705
    • Research Site
  • Taichung, Taiwan, 433004
    • Research Site
  • Taipei, Taiwan, 100
    • Research Site
  • Taipei, Taiwan, 0116
    • Research Site
  • Taipei, Taiwan, 110
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  • Taoyuan District, Taiwan, 333
    • Research Site
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 1330
    • Research Site
  • Altındağ-Ankara, Turkey (Türkiye), 06230
    • Research Site
  • Ankara, Turkey (Türkiye)
    • Research Site
  • Istanbul, Turkey (Türkiye), 34854
    • Research Site
  • Kırıkkale, Turkey (Türkiye), 71450
    • Research Site
  • Mersin, Turkey (Türkiye), 33079
    • Research Site
• Ukraine
  • Chernivtsі, Ukraine, 58002
    • Research Site
  • Ivano-Frankivsk, Ukraine, 76018
    • Research Site
  • Ivano-Frankivsk, Ukraine, 76019
    • Research Site
  • Kyiv, Ukraine, 02002
    • Research Site
  • Kyiv, Ukraine, 03037
    • Research Site
  • Kyiv, Ukraine, 03049
    • Research Site
  • Kyiv, Ukraine, 03680
    • Research Site
  • Kyiv, Ukraine, 02081
    • Research Site
  • Lutsk, Ukraine, 43000
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  • Uzhhorod, Ukraine, 88018
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  • Vinnytsia, Ukraine, 21029
    • Research Site
• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
    • Research Site
  • Liverpool, United Kingdom, L7 8XP
    • Research Site
  • Portsmouth, United Kingdom, PO6 3LY
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• United States
  • Arizona
    • Mesa, Arizona, United States, 85213
      • Research Site
  • California
    • Huntington Beach, California, United States, 92647
      • Research Site
    • La Mesa, California, United States, 91942
      • Research Site
    • Laguna Niguel, California, United States, 92677
      • Research Site
    • Lancaster, California, United States, 93534
      • Research Site
    • Long Beach, California, United States, 90815
      • Research Site
    • San Jose, California, United States, 95117
      • Research Site
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Research Site
  • Florida
    • DeBary, Florida, United States, 32713
      • Research Site
    • Jacksonville, Florida, United States, 32216
      • Research Site
    • Jensen Beach, Florida, United States, 34957
      • Research Site
    • Largo, Florida, United States, 33777
      • Research Site
    • Miami, Florida, United States, 33135
      • Research Site
    • Miami Lakes, Florida, United States, 33014
      • Research Site
    • Tampa, Florida, United States, 33607
      • Research Site
  • Georgia
    • Lilburn, Georgia, United States, 30047
      • Research Site
    • Savannah, Georgia, United States, 31406
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Research Site
    • Winfield, Illinois, United States, 60190
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  • Iowa
    • Ames, Iowa, United States, 50010
      • Research Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
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  • Maryland
    • Baltimore, Maryland, United States, 21237
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  • Massachusetts
    • Methuen, Massachusetts, United States, 01844
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  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Research Site
    • Detroit, Michigan, United States, 48202
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Research Site
    • Las Vegas, Nevada, United States, 89102
      • Research Site
  • New Jersey
    • Riverdale, New Jersey, United States, 07457
      • Research Site
  • New York
    • Middletown, New York, United States, 10941
      • Research Site
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Research Site
    • Winston-Salem, North Carolina, United States, 27104
      • Research Site
  • Ohio
    • Beavercreek, Ohio, United States, 45431
      • Research Site
    • Lima, Ohio, United States, 45801
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  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Research Site
  • Pennsylvania
    • Horsham, Pennsylvania, United States, 19044
      • Research Site
  • Texas
    • Austin, Texas, United States, 78704
      • Research Site
    • McKinney, Texas, United States, 75069
      • Research Site
    • Mesquite, Texas, United States, 75149
      • Research Site
    • Pearland, Texas, United States, 77584
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    • San Antonio, Texas, United States, 78215
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  • Utah
    • American Fork, Utah, United States, 84003
      • Research Site
    • Roy, Utah, United States, 84067
      • Research Site
    • Salt Lake City, Utah, United States, 84124
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  • Virginia
    • Hampton, Virginia, United States, 23666
      • Research Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53228
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Principal inclusion criteria (abbreviated):

1. Patient must be 18 to 80 years of age inclusive
2. Documented physician diagnosis of asthma for at least 12 months, with objective evidence of asthma (spirometric, bronchial challenge, exercise challenge or therapeutic response) within the last 5 years

4. Uncontrolled asthma (i.e. ACQ-6 ≥ 1.5)

5. Pre-BD FEV1 ≥ 40%

7. A history of asthma exacerbations within the last 12 months

8. & 9. Compliant with asthma background mediation, daily ePROs and daily home spirometry.

10. BMI within the range 18-37 kg/m2 (inclusive)

11. Female patients of child bearing potential must not be pregnant and agree to use highly effective contraception.

12. Male patients and their female partners of childbearing potential must agree to use highly effective contraception.

13. Capable of giving signed informed consent.

Principal exclusion criteria (abbreviated):

1. History of life-threatening asthma
2. Recently completed treatment for respiratory infection and/or asthma exacerbation
3. Clinically important pulmonary disease other than asthma; including but not limited to those with co-existent chronic obstructive pulmonary disease.

4. Any disorder that is not stable in the opinion of the Investigator and could:

   1. Affect the safety of the patient throughout the study
   2. Influence the findings of the study or their interpretation
   3. Impede the patient's ability to complete the entire duration of study
5. Patients who, in the opinion of the Investigator, have evidence of active TB or are currently on treatment for active or latent TB.
6. Medical history of or treatment for hepatitis B or hepatitis C, except for cured hepatitis C
7. Patients with history of HIV infection or who test positive for HIV.
8. Congenital long QT syndrome or prolonged QTcF > 470 ms or history of QT prolongation associated with other medications that required discontinuation of that medication.
9. Current untreated or uncontrolled arrhythmia.
10. Patients with recent myocardial infarction, unstable angina pectoris, stroke, percutaneous coronary intervention or coronary artery bypass grafting.
11. A helminth parasitic infection diagnosed that has not been treated, or has not responded to SoC therapy.
12. Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months ago.
13. Known history of drug or alcohol abuse within 12 months, that in the Investigator's opinion would preclude participation in the study.
14. Current diagnosis of cancer or unresectable cancer that has not been in complete remission for at least 5 years.
15. Any other clinically relevant abnormal findings that in the opinion of the Investigator or medical monitor might compromise the safety of the patient in the study or interfere with evaluation of the study intervention.
16. Treatment with marketed or investigational biologics within 4 months or a minimum of 5 half-lives.
17. Treatment with Systemic steroids within 4 weeks.
18. Chronic oral or systemic CS use for asthma or for any other indication (with the exception of stable replacement therapy in adrenal insufficiency).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AZD8630 dose A; Inhaled AZD8630 administered at a dose A	Drug: AZD8630; The drug will be administered by inhalation; Device: Inhaler; The drug/placebo will be administered by inhalation using the inhaler
Experimental: AZD8630 dose B; Inhaled AZD8630 administered at a dose B	Drug: AZD8630; The drug will be administered by inhalation; Device: Inhaler; The drug/placebo will be administered by inhalation using the inhaler
Experimental: AZD8630 dose C; Inhaled AZD8630 administered at a dose C	Drug: AZD8630; The drug will be administered by inhalation; Device: Inhaler; The drug/placebo will be administered by inhalation using the inhaler
Placebo Comparator: Placebo; Inhaled placebo	Device: Inhaler; The drug/placebo will be administered by inhalation using the inhaler; Drug: Placebo; The placebo will be administered by inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first CompEx Asthma event	The CompEx Asthma is a composite endpoint for exacerbations that captures asthma-worsening episodes based on combination of diary events (worsening in daily PEF, asthma symptoms and rescue medication use) plus severe asthma exacerbation events. Diary events are defined by threshold and slope criteria using the following morning/evening diary variables: PEF; Asthma symptom score (0 to 3); Use of rescue medication	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-BD FEV1	Change from baseline in pre-bronchodilator forced expiratory volume in 1 second.	12 weeks
ACQ-6:	Change from baseline in the Asthma Control Questionnaire 6 (ACQ-6). The ACQ-6 has 6 questions (regarding asthma symptoms and rescue bronchodilator use). Answering the questions results in a score out of 6. A Score of 0 indicates complete control and 6 reflects severely uncontrolled disease	12 weeks
AQLQ12+	Change from baseline in the Asthma Quality of Life Questionnaire for 12 Years and Older. The AQLQ12+ includes 32 questions grouped into four domains: symptoms; activity limitations; emotional function; and, environmental stimuli. Each question is scored on a seven-point Likert scale, which ranges from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean of all questions, and the four domain scores are the means of the scores for the questions in the respective domains	12 weeks
SGRQ	Change from baseline in the St. George's Respiratory Questionnaire. The SGRQ includes 50 questions grouped into two parts: Part 1 : Symptoms component (frequency & severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall.	12 weeks
FeNO	Change from baseline to: FeNO: Weeks 1, 2, 4, 8, and 12	12 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Njira Lugogo, Univeristy of Michigan Hospital, Ann Arbor, MI, US

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2024
• Primary Completion (Actual): February 4, 2026
• Study Completion (Actual): February 4, 2026

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Equipment and Supplies; Nebulizers and Vaporizers
• Other Study ID Numbers: D6830C00003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes