The ZION study
Now Enrolling: A clinical study for adults with COPD with a Type 2 inflammatory phenotype
Refer a Patient
We’re going the distance in COPD research.
Now enrolling patients with COPD for a subcutaneous (SC) injection study.
The ZION clinical study is assessing the safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of solrikitug when administered via subcutaneous injection in participants with COPD who have evidence of elevated type 2 inflammatory markers.
This study will evaluate 2 doses of SC solrikitug vs placebo. Solrikitug is:
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A biologic
■
Lyophilized powder in vial for reconstitution
■
To be administered as a SC injection into each arm (to be completed 3 times over a 12-week treatment period followed by a safety evaluation period)
ZION is a Phase 2 study that is:
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Randomized
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Double-blind
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Placebo-controlled
The primary objective of the ZION study is to assess the effect of solrikitug on blood eosinophil counts compared with placebo.
ZION is now enrolling. Your patients with COPD could qualify.
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Inclusion Criteria
Exclusion Criteria
Each participant must meet the following criteria to be enrolled in this study.
1.
Participant has signed, dated, and received a copy of the Institutional Review Board (IRB) or Independent Ethics Committee (IEC)-approved written Informed Consent Form (ICF).
2.
Participant is considered reliable and capable of adhering to the protocol and visit schedule according to the judgement of the Investigator.
3.
Participant is male or female at least 40 years of age and no older than 75 years at Screening Visit 1.
4.
Participant has a body mass index between >18.5 and <40 kg/m2 at Screening Visit 1.
5.
Participant has a documented diagnosis of COPD for at least 12 months prior to Screening, defined by the GOLD Guidelines (2023) as a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction.
6.
Participant has airflow limitation meeting the following criteria:
a.
At Screening Visit 1 (or Visit 1b, if needed), post-bronchodilator FEV1 must be ≥40% to <80% predicted normal value calculated using Global Lung Function Initiative (GLI) reference equations (Cooper et al 2017) and the post-bronchodilator FEV1/FVC ratio must be <0.70.
Note: Participant spirometry assessments must meet the acceptability standards specified by American Thoracic Society (ATS)/European Respiratory Society (ERS) at Screening Visits 1 or 1b (if needed) and at Visit 2.
7.
Participant is a current smoker (up to 25% of population) or former smoker with a history of at least 10 pack-years of cigarette smoking. (Number of pack-years = [number of cigarettes per day/20] x number of years smoked [e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years represent 10 pack-years]).
8.
Symptomatic (COPD Assessment Test [CAT] Score ≥10) at Screening Visit 1.
9.
Required COPD maintenance therapy:
a.
Participants must be on 2 or more inhaled maintenance medications for management of their COPD, which may be administered either once or twice daily, for at least 3 months prior to Screening: a combination inhaled long-acting muscarinic antagonist (LAMA)/long-acting beta agonist (LABA), inhaled corticosteroid (ICS)/LABA, or a LAMA/LABA or ICS/LABA as part of an approved triple therapy for COPD (ICS/LABA/LAMA).
b.
Participants taking once-daily medications must be willing to take them in the morning from Screening Visit 1 through the duration of the study.
c.
Participant is on stable, non-biologic, background COPD medication with no dose adjustments for ≥6 weeks prior to Screening.
d.
Participant has not started any new prescribed drugs for non-respiratory conditions or had any dose adjustments in these prescribed drugs in the 4 weeks prior to Screening.
10.
Participant has a Type 2 inflammatory COPD phenotype defined as:
a.
Blood eosinophil count ≥150 and <300 cells/μL at Screening Visit 1 (or Visit 1b, if needed), and elevated FeNO as follows:
I.
FeNO level ≥25 ppb at Screening Visit 1 or Visit 1b (if needed), or
II.
Historical documented FeNO ≥25 ppb within 8 weeks prior to Screening Visit 1 and FeNO ≥20 ppb at Screening Visit 1 (or Visit 1b, if needed).
OR
b.
Blood eosinophil count ≥300 and ≤1500 cells/μL as follows:
I.
Blood eosinophil count ≥300 cells/μL at Screening Visit 1 or Visit 1b (if needed).
II.
Historical documented blood eosinophil count ≥300 cells/μL within 8 weeks prior to Screening Visit 1 and ≥250 cells/μL at Screening Visit 1 (or Visit 1b, if needed).
Participant with a blood eosinophil count ≥300 and ≤1500 cells/μL can have any FeNO level at Screening Visit 1.
11.
This FeNO inclusion criterion #11 has been deleted as of this protocol amendment (Amendment 5, Version 6.0) and is part of the Type 2 phenotype strata as defined in inclusion criterion #10. An empty inclusion criterion #11 has been maintained for operational purposes.
12.
Participant has high-resolution computed tomography (HRCT) scan of the chest/lungs within 3 months prior to Screening Visit 1 that is acceptable to the Investigator. An HRCT scan must be conducted if the most recent HRCT scan is more than 3 months old at the time of Screening Visit 1.
13.
Participant has normal or clinically acceptable physical examination, vital signs, clinical laboratory values, and ECG at Screening.
14.
Male participants and female participants of childbearing potential agree to use highly effective contraception/preventive exposure measures from the time of first dose of study drug (for the male participant) or the signing of the ICF (for the female participant), during the study, and for at least 5 half-lives of solrikitug (140 days) after the last dose of study drug. Participants agree not to donate eggs or sperm during the same period.
a.
A highly effective method of contraception is defined as one that results in a low failure rate (i.e., <1% per year) when used consistently and correctly. The acceptable methods of contraception include: sexual abstinence, a vasectomized partner, bilateral tubal occlusion, any effective intrauterine device/system, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, and double-barrier method (e.g., male or female condom with spermicide). Note: the double-barrier method does not meet the standards for highly effective contraception in certain regions (e.g., New Zealand) and alternative methods of highly effective contraception are a requirement.
15.
Female participants of nonchildbearing potential will be included if they meet the following definition of nonchildbearing potential: are either surgically sterile (hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy at least 26 weeks prior to Screening Visit 1) or postmenopausal, defined as spontaneous amenorrhea for at least 1 year, and/or with follicle-stimulating hormone (FSH) in the postmenopausal range at Screening Visit 1, based on the central laboratory’s ranges.
Each participant must meet the following criteria to be enrolled in this study.
1.
Female participant who is pregnant or breastfeeding.
2.
Participant is an employee, consultant, and/or immediate family member (i.e., first degree relative, spouse, adoptees, or legal dependents) of the site, Sponsor, or DevPro Biopharma.
3.
Participant has a known hypersensitivity to any component of the formulation of solrikitug, including any of the excipients, or a history of anaphylactic reaction to any therapeutic monoclonal antibody.
4.
Participant has had an exacerbation of COPD (defined as an event characterized by increased dyspnea and/or cough and sputum that worsens in <14 days, which may be accompanied by tachypnea and/or tachycardia and is often associated with increased local and systemic inflammation; adapted from GOLD 2023) in the 8 weeks prior to Screening or during the Screening Period.
5.
Participant has clinically significant findings during the Screening Period as determined by the Investigator following discussion with the Medical Monitor.
6.
Participant has history or evidence of any clinically significant cardiovascular (including uncontrolled hypertension or cor pulmonale [evidence of right cardiac failure]), gastrointestinal, endocrinologic (including uncontrolled diabetes), hematologic, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, renal and/or other major disease, or any other condition that in the opinion of the Investigator or Medical Monitor might obfuscate the study data. With regard to malignancies:
a.
History of malignancy within the past 5 years unless previously treated with curative intent and with no evidence of recurrence or progression including but not limited to:
I.
carcinoma in situ of the uterine cervix,
II.
basal cell carcinoma of the skin,
III.
low risk prostate cancer (confined to prostate) that has been managed medically through active surveillance or watchful waiting,
IV.
fully resected squamous cell carcinoma of the skin,
V.
ductal carcinoma in situ of the breast, or
VI.
ductal carcinoma in situ of the breast, or
7.
Participant has history or evidence of any clinically significant pulmonary condition, including significant restrictive findings on pulmonary function testing, bronchiectasis (HRCT evidence of bronchiectasis that cause repeated acute exacerbations), and pulmonary fibrosis, active tuberculosis, or any other related condition that in the opinion of the Investigator or Medical Monitor might obfuscate the study data (e.g., vocal cord paralysis/dysfunction).
8.
Participant has a current diagnosis of asthma according to accepted guidelines (e.g., current Global Initiative for Asthma [GINA] guidelines [2024]), any active asthma requiring pharmacologic treatment within 5 years of Screening, or any documented history of asthma diagnosis ≥40 years of age.
9.
Participant has alpha-1 antitrypsin deficiency as the cause of COPD.
10.
Participant has a baseline HRCT scan that demonstrates significant radiographic emphysema (>25% whole lung) or has a diagnosis of severe bronchiectasis.
11.
Participant has other active pulmonary disease such as lung cancer, sarcoidosis, idiopathic interstitial pulmonary fibrosis (IPF), primary pulmonary hypertension, or uncontrolled sleep apnea that, in the opinion of the Investigator, the severity of the disorder would impact the conduct of the study. NOTE: Use of continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP) for the management of sleep apnea is allowed.
12.
Participant has undergone lung volume reduction surgery, lobectomy or bronchoscopic lung volume reduction (endobronchial blockers, airway bypass, endobronchial valves, thermal vapor ablation, biological sealants, and airway implants) within 1 year of Screening Visit 1.
13.
Participant has a lower respiratory tract infection that required antibiotics within 6 weeks prior to Screening.
14.
Participant has pneumonia that has not clinically resolved at least 14 days prior to Screening.
15.
Participant who cannot adhere to spirometry performance:
a.
Acceptability: Participant who cannot perform acceptable spirometry (i.e., meet ATS/ERS acceptability criteria).
b.
Repeatability: Participant who cannot perform technically acceptable spirometry with at least 3 acceptable flow-volume curves with 2 or more meeting ATS repeatability criteria for FEV1 during at least 1 of the pre-bronchodilator assessments at Visit 2 (--60 minutes or -30 minutes).
16.
Participant is receiving long-term-oxygen therapy (LTOT) >12 hours/day. Note: As needed oxygen use is not exclusionary.
17.
Participant has change in smoking status (i.e., start or stop smoking) or initiation of a smoking cessation program within 6 weeks prior to Screening.
18.
Participant has participated in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1 or who will enter the acute phase of a pulmonary rehabilitation program during the Screening Period. Participants who are in the maintenance phase of a pulmonary rehabilitation program are not to be excluded.
19.
Participant has initiated or altered the dose regimen of intranasal corticosteroids, intranasal antihistamines, or a combination thereof within 14 days prior to Screening. Note: Allergic rhinitis is not exclusionary.
20.
Participant has unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 6 months prior to Screening. Participants with a recent history of acute coronary syndrome, or who have undergone percutaneous coronary intervention or coronary artery bypass graft within 3 months prior to Screening are to be excluded.
21.
Participant has congestive heart failure (CHF New York Heart Association Class III/IV).
22.
Participant has a mean corrected QT interval (QTc; using Fridericia’s [QTcF] formula) of ≥470 msec during the Screening Period, or:
a.
Has a clinically significant conduction abnormality (e.g., left bundle branch block, Wolff-Parkinson-White syndrome or evidence of second degree [Mobitz Type II] or third-degree atrioventricular block [unless pacemaker or defibrillator has been inserted]).
b.
Has a clinically significant arrhythmia (e.g., atrial fibrillation with irregular ventricular response, atrial flutter, ventricular tachycardia). Note: atrial fibrillation that has been clinically stable for at least 6 months and that has been appropriately treated with anticoagulation and controlled with a rate control strategy (i.e., selective beta blocker, calcium channel blocker, digoxin or ablation therapy) for at least 6 months is allowed for inclusion. If atrial fibrillation is present at Screening Visit 1, resting ventricular rate must be <100 beats per minute (bpm).
23.
Participant has any other ECG abnormality not listed in exclusion criterion #22 that in the opinion of the Investigator is clinically significant.
24.
Participant has evidence of any active or suspected bacterial, viral, fungal or parasitic infections within 4 weeks prior to Screening (e.g., sinusitis, common cold, viral syndrome, flu-like symptoms).
25.
Participant has a history compatible with parasitic infection or if diagnosed within 6 months prior to Screening that has not been treated or has not responded to standard of care therapy.
26.
Participant has an estimated glomerular filtration rate of <30 mL/min/1.73 m2.
27.
Participant has abnormal liver function tests defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥3x upper limit of normal (ULN) or total bilirubin ≥1.5xULN at Screening Visit 1.
28.
Participant has history or suspected history of alcohol misuse or substance abuse within 6 months prior to Screening.
29.
Participants with any other condition that could lead to elevated eosinophils such as hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis.
30.
Participant has a known history of immune deficiency, including but not limited to human immunodeficiency virus (HIV).
31.
Participant has a positive test for hepatitis B surface antigen or hepatitis C virus (HCV) antibody (anti-HCV) at Screening Visit 1.
32.
Participant has received any live/attenuated vaccine within 30 days prior to Screening.
33.
Participant has received any of the following immunosuppressant therapies within 6 months prior to Screening: imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporine A, bosentan, or methotrexate.
34.
Participant has received any antibody or therapeutic biologic product within 6 months or 5 half-lives (whichever is shorter) prior to Screening.
35.
Participant has received immunotherapy, including sublingual immunotherapy, at an unstable dose or has had a change to the dose or dose regimen within 12 weeks prior to Screening. Participants unwilling to continue on a stable dose for the duration of the study will be excluded.
36.
Participant has received any oral, IV, or intramuscular steroid within 2 months prior to Screening. Intrathecal or intra-articular steroids are permitted.
37.
Participant requires chronic daily or alternate-day oral corticosteroid (OCS) to control their COPD.
38.
Participant has participated in any interventional clinical study or had been treated with any investigational drugs within 28 days or 5 half-lives, whichever is longer, prior to Screening.
39.
Participant has a known lack of adherence to maintenance COPD medications.
Study Site Locations
Click on the map below to see study site locations near you.
Location
330 First Capitol Dr, Suite 470, St. Charles, MO, 63301
Thomas Siler, thomas.siler.md@midwestchest.com, 636-946-1650
Samantha Roark, sjroark20@gmail.com, 636-946-1650 (ext 442)
3121 Signature Ct., Medford, OR, 97504
Sarah Smiley, ssmiley@velocityclinical.com, 541-494-3219
Wyatt Croy, wcroy@velocityclinical.com, 541-858-1018
1501 Superior Ave, Suite 202, Newport Beach, CA, 92663
Ryan Klein, Ryan@newportnativemd.com, 949-791-8599
Taylor Rosen, taylor@newportnativemd.com, 949-791-8599
141 Harold Fleming Ct, Spartanburg, SC, 29303
Farhan Siddiqui, fsiddiqui@velocityclinical.com, 864-515-0092
Allison Kelly, akelly@velocityclinical.com, 864-515-0092
12025 Louetta Rd #B, Houston, TX, 77070
Rajenda Pandya, Rpanda@gulfcoasttrials.com, 832-594-1732
Abiel Rusvid, ARusvid@gulfcoasttrials.com, 832-603-2432
501 Roper Mountain Rd, Greenville, SC, 29615
Luis De La Cruz, ldelacruz@velocityclinical.com, 864-770-0890
Taylor Barnes, tbarnes@velocityclinical.com, 864-770-0890
1655 Bernardin Ave, Suite 300, Columbia, SC, 29204
Gregory Feldman, gfeldman@velocityclinical.com, 803-766-2680
Sangeetha Gajula, sgajula@velocityclinical.com, 803-766-2680
1005 Thompson Blvd, Union, SC, 29379
Joseph Boscia, jboscia@velocityclinical.com, 864-427-1172
Carita Barefoot, cbarefoot@velocityclinical.com, 864-427-1172
1529 N. Limestone St., Gaffney, SC, 29340
David Erb, derb@velocityclinical.com, 864-488-1283
Ashley Rochester, arochester@velocityclinical.com, 864 488-1283
1055 Wilshire Blvd, Suite 1660, Los Angeles, CA, 90017
Salil Nadkarni, snadkarni@dtlaresearch.com, 213-261-3680
Claudia Cisneros, ccisneros@dtlaresearch.com, 213-261-3680
10700 Caribbean Blvd, Suite 21, Cutler Bay, FL, 33189
Dr. Nelson Gonzalez, ngonzalez@jyresearchinstitute.com, 305-424-8696
Avila Ismelda, iavila@jyresearchinstitute.com, 305-424-8696
1335 Dublin Rd, Suite 106A, Columbus, OH, 43215
Roy St. John, rstjohn@remdavis.com, 614-487-2560
Eve Horrigan, Ehorrigan@remdavis.com, 614-487-2560
29255 W 10 Mile Rd, Suite A, Farmington Hills, MI, 48336
Irina Shanidze, pulmonary.research3@gmail.com, 248-478-6561
Meena Krishnamony, pulmonary.research5@gmail.com, 248-478-6561
401 Lewis Hargett Cir, Suite 120, Lexington, KY, 40503
Justin Arambasick, drarambasick@researchgrouplexington.com, 786-220-1146
Christy Douglas, christy@researchgrouplexington.com, 859-971-4005
1867 Williams Highway, Suite 109A, Grants Pass, OR, 97527
John Delgado, jdelgado@velocityclinical.com, 541-237-0323
Tessa Reed, treed@velocityclinical.com, 541-237-0323
6914 Office Park Cir, Knoxville, TN, 37909
Amanda Miller, amiller@newphaseresearch.com, 865-200-8364
Broden Katrin, kbroden@newphaseresearch.com, 865-200-8364
1573 South Fort Harrison Ave, Clearwater, FL, 33756
Miguel Trevino, Miguelt@innovativeresearchfl.com, 727-584-6368
Osborn Tracey, Traceyo@innovativeresearchfl.com, 727-584-6368
12361 W. Bola Dr, Suite 110, Surprise, AZ, 85378
Rachel Greatwood, rgreatwood@epicmedresearch.com, 623-223-5725
Akshaya Jayasekaran, ajayasekaran@epicmedresearch.com, 972-777-6956
180 Fort Couch Rd, Suite 375, Pittsburgh, PA, 15241
James DeAngelo, Deangelo.james@gmail.com, 412-833-4051
Sherry Knoblock, Sherryknoblock@gmail.com, 412-833-4051
2673 Palmer, Suite 102, Missoula, MT, 59808
Richard Sellman, rsellman@montanamedicalresearch.com, 406-549-1124
Peter Szekely, pszekely@montanamedicalresearch.com, 406-549-1124
Click to copy and paste nearby study site locations into your patient notes.
Who can participate in this study?
Patients who meet the following criteria may qualify:
Male or female 40 to 75 years of age
Documented diagnosis of COPD for at least 12 months
Post-bronchodilator FEV1 must be ≥40% to <80% predicted normal value and the post-bronchodilator FEV1/FVC ratio must be <0.70
Current smoker or former smoker with a history of at least 10 pack-years of cigarette smoking*†
*25% of participants must be current smokers.
†Number of pack-years = [number of cigarettes per day/20] x number of years smoked [e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years represent 10 pack-years]).
This is not a full list of criteria. Click to see the full eligibility criteria.
Full Eligibility Criteria
Study Summary
Study Drug:
subcutaneously
Study Objective:
is to assess the effect
of solrikitug on blood eosinophil counts
compared with placebo.
Participant Details:
with COPD
Sponsor
Enrollment Period:
Refer a patient
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