1. Kimura S, Pawankar R, Mori S, et al. Increased expression and role of thymic stromal lymphopoietin in nasal polyposis. Allergy Asthma Immunol Res. 2011;3:186-193.
The information contained on this page is intended only for healthcare providers practicing in the United States.
Patient Website
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Please share in your patient’s notes.
The VIBRANT study
Now Enrolling:
A clinical study for adults experiencing chronic
rhinosinusitis with nasal polyps (CRSwNP)
A clinical study for adults experiencing chronic
rhinosinusitis with nasal polyps (CRSwNP)
Refer a Patient
Refer a patient
CRSwNP can significantly impair quality of life.
More research is necessary.
The VIBRANT clinical study is researching verekitug (UPB-101) in adults with CRSwNP on a background of nasal corticosteroids.
Verekitug is:
●
A fully human immunoglobulin G1 monoclonal antibody
●
Designed to target and block human thymic stromal lymphopoietin (TSLP) signaling
TSLP is widely recognized as a key regulator of type 2 inflammation and is implicated in the pathogenesis of type 2 related inflammatory disease including CRSwNP.1
VIBRANT is a Phase 2 study that is:
●
Randomized
●
Double blind
●
Placebo controlled
The primary objective of the VIBRANT study is to assess the effect of verekitug (UPB-101) on endoscopic nasal polyp score (NPS) compared to placebo,
as measured by change in NPS from baseline to end of study treatment (week 24).
VIBRANT is now enrolling. Your patients with CRSwNP could qualify.
Reference:
Copy the patient website link into your notes.
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Study Site Locations
Click on the map below to see study site locations near you. Please contact the site closest to you for study inquiries or to discuss a patient referral.
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Location
Allergy, Asthma, & Immunology Associates of Tampa Bay
13801 Bruce B. Downs Blvd. Ste. 505
Tampa, FL 33613
Seong-Ho Cho, Scho2@usf.edu,813-631-4024
Eugenia Alas, Eugenia4@usf.edu,813-631-4024
13801 Bruce B. Downs Blvd. Ste. 505
Tampa, FL 33613
Seong-Ho Cho, Scho2@usf.edu,
Eugenia Alas, Eugenia4@usf.edu,
Advanced ENT and Allergy
2944 Breckenridge Ln.
Louisville, KY 40220
Andrew Gould, agould@advancedentandallergy.com,502-893-0159
Jennifer Leonard, jleonard@advancedentandallergy.com,502-893-0159
2944 Breckenridge Ln.
Louisville, KY 40220
Andrew Gould, agould@advancedentandallergy.com,
Jennifer Leonard, jleonard@advancedentandallergy.com,
Eastern Virginia Medical School EVMS Medical Group
600 Gresham Dr. Ste 1100
Norfolk, VA 23507
Joseph Han, hanjk@evms.edu,757-388-6238
Patrick Felan, felanpo@evms.edu,757-388-6238
600 Gresham Dr. Ste 1100
Norfolk, VA 23507
Joseph Han, hanjk@evms.edu,
Patrick Felan, felanpo@evms.edu,
Tandem Clinical Research GI, LLC
1151 Barataria Blvd. Ste. 3200
Marrero, LA 70072
Adil Fatakia, drfatakia@tandemclinicalresearch.com,504-934-8424
Antoinette Hymel, ahymel@tandemclinicalresearch.com,504-934-8424
1151 Barataria Blvd. Ste. 3200
Marrero, LA 70072
Adil Fatakia, drfatakia@tandemclinicalresearch.com,
Antoinette Hymel, ahymel@tandemclinicalresearch.com,
Orion Clinical Research
11645 Angus Rd. Ste. B6
Austin, TX 78759
William Howland, drh@orionclinicalresearch.com,512-492-3797
Stephanie Faye Nunnelee, sfnunnelee@orionclinicalresearch.com,512-492-3797
11645 Angus Rd. Ste. B6
Austin, TX 78759
William Howland, drh@orionclinicalresearch.com,
Stephanie Faye Nunnelee, sfnunnelee@orionclinicalresearch.com,
Ears Nose and Throat Associates of Texas
6717 W. Eldorado Pkwy. Ste. 140
McKinney, TX 75070
Chad McDuffie, cmcduffie@enttex.net,972-731-7654
Katharine Radovic, kradovic@berksonmedical.com,682-718-1778
6717 W. Eldorado Pkwy. Ste. 140
McKinney, TX 75070
Chad McDuffie, cmcduffie@enttex.net,
Katharine Radovic, kradovic@berksonmedical.com,
Treasure Valley Medical Research
1000 N. Curtis Rd. Ste. 102
Boise, ID 83706
Neetu Talreja, ntalreja@tvmedresearch.com,208-813-6505
Cheri Hogue, chogue@tvmedresearch.com,208-813-6505
1000 N. Curtis Rd. Ste. 102
Boise, ID 83706
Neetu Talreja, ntalreja@tvmedresearch.com,
Cheri Hogue, chogue@tvmedresearch.com,
Allergy Asthma & Clinical Research Cent
4200 W. Memorial Rd. Ste. 206
Oklahoma City, OK, 73120
Martha Tarpay, mtarpay@mtarpay.com,405-286-9431
Shereen Jasasra, Crc3@mtarpay.com,405-286-9431
4200 W. Memorial Rd. Ste. 206
Oklahoma City, OK, 73120
Martha Tarpay, mtarpay@mtarpay.com,
Shereen Jasasra, Crc3@mtarpay.com,
IMIC Inc
9380 SW 150th St. Ste. 140
Miami, FL 33176
Ramon Leon, ramon@aktamedika.com,786-310-7477
Teresa Valencia, teresa@aktamedika.com,786-310-7477
9380 SW 150th St. Ste. 140
Miami, FL 33176
Ramon Leon, ramon@aktamedika.com,
Teresa Valencia, teresa@aktamedika.com,
Chesapeake Clinical Research Inc
Chesapeake Clinical Research Inc. 5430 Campbell Blvd. Ste. 110
White Marsh, MD 21162
Jonathan Matz, jonathanmatz@yahoo.com,410-931-1966 x 106
Geri Novak, gnovak.ccr@gmail.com,410-931-1966 Ext 103
Chesapeake Clinical Research Inc. 5430 Campbell Blvd. Ste. 110
White Marsh, MD 21162
Jonathan Matz, jonathanmatz@yahoo.com,
Geri Novak, gnovak.ccr@gmail.com,
NewportNativeMD Inc.
1501 Superior Ave. Ste. 202
Newport Beach, CA 92782
Ryan Klein, ryan@newportnativemd.com,949-791-8599
Jennifer Gonzalez, jennifer@newportnativemd.com,949-791-8599
1501 Superior Ave. Ste. 202
Newport Beach, CA 92782
Ryan Klein, ryan@newportnativemd.com,
Jennifer Gonzalez, jennifer@newportnativemd.com,
Northwell Health
865 Northern Blvd. Ste. 101
Great Neck, NY 11021
Blanka Kaplan, bkaplan@northwell.edu,516-622-5070
Ali Aaqil,516-622-5064
865 Northern Blvd. Ste. 101
Great Neck, NY 11021
Blanka Kaplan, bkaplan@northwell.edu,
Ali Aaqil,
Brigham and Women's Hospital
75 Francis Street Tower L2
Boston, MA 02115
Stella Lee, slee192@bwh.harvard.edu,1-773-220-0650
Simon Chiang, schiang6@bwh.harvard.edu,1-617-525-3724
75 Francis Street Tower L2
Boston, MA 02115
Stella Lee, slee192@bwh.harvard.edu,
Simon Chiang, schiang6@bwh.harvard.edu,
Brigham Women’s Hospital
15 Francis Street, Carrie Hall 4 Otolaryngology
Boston, MA 02115
Simon Chiang, schiang6@bwh.harvard.edu,1-617-525-3724
15 Francis Street, Carrie Hall 4 Otolaryngology
Boston, MA 02115
Simon Chiang, schiang6@bwh.harvard.edu,
Western States Clinical Research, Inc.
4251 Kipling St. Ste. 540
Wheat Ridge, CO 80033
Jeffrey Rumbyrt, rumbyrt@wscrinc.com,303-940-9773
Mary Reid, mary@wscrinc.com,303-940-9773
4251 Kipling St. Ste. 540
Wheat Ridge, CO 80033
Jeffrey Rumbyrt, rumbyrt@wscrinc.com,
Mary Reid, mary@wscrinc.com,
Davinci Research
1504 Eureka Road Ste. 360
Roseville, CA 95661
Randall Ow, row@sacent.com,916-374-6730
Rose Khalatyan, rkhalatyan@davinciresearch.net,916-531-2788
1504 Eureka Road Ste. 360
Roseville, CA 95661
Randall Ow, row@sacent.com,
Rose Khalatyan, rkhalatyan@davinciresearch.net,
University of Cincinnati Medical Center
231 Albert Sabin Wy. Ste. 6004
Cincinnati, OH 45267
Ahmad Sedaghat, sedaghad@ucmail.uc.edu,513-475-8400
Becky Reinert, gibsonrk@uc.edu,513-558-1719
231 Albert Sabin Wy. Ste. 6004
Cincinnati, OH 45267
Ahmad Sedaghat, sedaghad@ucmail.uc.edu,
Becky Reinert, gibsonrk@uc.edu,
Spartanburg / Greer ENT & Allergy
1095 Iron Ore Road
Spartanburg, SC 29303
Henry Butehorn, pi647@interspond.com,608-848-1552
Joseph Carey, jcarey@spartanburgent.com,864-278-1420
1095 Iron Ore Road
Spartanburg, SC 29303
Henry Butehorn, pi647@interspond.com,
Joseph Carey, jcarey@spartanburgent.com,
Alina Clinical Trials llc.
6114 Sherry Ln.
Dallas, TX 75225
Barbara Baxter, bjsbaxmd@gmail.com,214-363-1411
Estella Paredes, estellap6114@gmail.com,214-363-1411
6114 Sherry Ln.
Dallas, TX 75225
Barbara Baxter, bjsbaxmd@gmail.com,
Estella Paredes, estellap6114@gmail.com,
Alamo Ent Associates
19026 Stone Oak Pkwy Ste 110
San Antonio, TX 78258
Jeffrey Rosenbloom, dr.jeffrey.rosenbloom@gmail.com,210-545-0404
Robert Gonzalez, r.gonzalez@alamoent.com,210-545-0404 Ext 1324
19026 Stone Oak Pkwy Ste 110
San Antonio, TX 78258
Jeffrey Rosenbloom, dr.jeffrey.rosenbloom@gmail.com,
Robert Gonzalez, r.gonzalez@alamoent.com,
Alfa Medical Research
7777 Davie Road Ext. Suite 202A
Hollywood, Fl. 33024
Ausberto Hidalgo, drhidalgo.alfamedicalgroups@gmail.com,754-263-3626
Claudia Ramirez, cramirez@alfamedicalgroups.com,754-263-3626
7777 Davie Road Ext. Suite 202A
Hollywood, Fl. 33024
Ausberto Hidalgo, drhidalgo.alfamedicalgroups@gmail.com,
Claudia Ramirez, cramirez@alfamedicalgroups.com,
Allergy Asthma & Sinus Center
8585 W Forest Home Avenue Ste. 200
Greenfield, WI 52338
Steven Gray, gsteven@myaasc.com,
Jennifer Kuhl, studies@myaasc.com, jkuhl@myaasc.com,
Bellingham Asthma Allergy and Immunology Clinic/CRN Clinical Research Network
3015 Squalicum Pkwy. Ste. 180
Bellingham, WA 98225
David Elkayam, ddelkayam@hinet.org,360-733-5733
Nancy Moore, njmoore@hinet.org,360-733-5733
3015 Squalicum Pkwy. Ste. 180
Bellingham, WA 98225
David Elkayam, ddelkayam@hinet.org,
Nancy Moore, njmoore@hinet.org,
ENT & Allergy Associates of Florida / Light ENT
9868 FL-7, US-441 Ste. 345
Boynton Beach, Fl. 33472
Joshua Light, Jlight@lightent.com,561-737-8594
Ariel Lee, ariel@lightent.com,561-805-3898 , 305-951-0666
9868 FL-7, US-441 Ste. 345
Boynton Beach, Fl. 33472
Joshua Light, Jlight@lightent.com,
Ariel Lee, ariel@lightent.com,
Novaceut Clinical Research
601 E. 49 Street
Hialeah, Fl. 33013
Richard Gonzalez, novaceut.ricky@gmail.com,305-681-3111
Raquel Gonzalez, novaceut.Raquel@gmail.com,305-681-3111
601 E. 49 Street
Hialeah, Fl. 33013
Richard Gonzalez, novaceut.ricky@gmail.com,
Raquel Gonzalez, novaceut.Raquel@gmail.com,
Sensa Health Clinical Research
966 S Western Ave. Suite 101
Los Angeles, CA 90006
Kevin Choi, kevin@sensahealth.org,213 528-4669
Jee Yang, jee@sensahealth.org,213 528-4669
966 S Western Ave. Suite 101
Los Angeles, CA 90006
Kevin Choi, kevin@sensahealth.org,
Jee Yang, jee@sensahealth.org,
University of Missouri
1 Hospital Dr. MA 317b
Columbia, MO. 65212
Christine Franzese, franzesec@health.missouri.edu,573-882-3275
Rebecca Schneider, schneiderri@health.missouri.edu,573-882-2549
1 Hospital Dr. MA 317b
Columbia, MO. 65212
Christine Franzese, franzesec@health.missouri.edu,
Rebecca Schneider, schneiderri@health.missouri.edu,
Wells Pharma Medical Research Corp.
7000 SW 97 Ave Ste. 210
Miami, Fl. 33173
Eddie Armas, drarmas@wpharma.com,305-665-4818 x 203
Katelyn Silva, ksilva@wpharma.com,305-665-4818 x 236
7000 SW 97 Ave Ste. 210
Miami, Fl. 33173
Eddie Armas, drarmas@wpharma.com,
Katelyn Silva, ksilva@wpharma.com,
Click to copy and paste nearby study site locations into your patient notes.
Copy site location
Who can participate in this study?
Patients who meet the following criteria may qualify:
●
18 to 75 years of age, inclusive
●
Diagnosed with CRSwNP for at least 6 months and all the following:
●
Severity consistent with need for surgery as defined by endoscopic bilateral NPS of ≥5
●
Ongoing symptoms of CRSwNP (e.g., rhinorrhea and/or hyposmia) for ≥8 weeks
●
In the last 24 months, had a documented exacerbation of nasal polyposis requiring treatment with systemic corticosteroids
AND/OR
AND/OR
●
Had a medical contraindication/intolerance to systemic corticosteroids
AND/OR
AND/OR
●
Had prior surgery for nasal polyps (NPs) (not within the last 6 months)
This is not a full list of criteria. Click to see the full eligibility criteria.
Full Eligibility Criteria
Study Summary
Study Drug:
Verekitug (UPB-101) or placebo, administered subcutaneously
Study Objective:
The primary objective is to assess the effect of verekitug on endoscopic NPS compared to placebo.
Participant Details:
18 to 75 years of age (inclusive) with CRSwNP
Sponsor
Enrollment Period:
Currently enrolling
Thank you
for considering
the VIBRANT clinical study for your patient(s) with CRSwNP.
A member of our team will be in touch with you shortly.
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Inclusion Criteria
Exclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Informed Consent
1.
Participant has signed, dated and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) as described in Appendix 1 (Section 10.1.3), which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Age
2.
Participant is aged 18 to 75 years of age (inclusive) at the time of signing the ICF.
Type of Participant and Disease Characteristics
3.
Participant has physician diagnosed CRSwNP for at least 6 months prior to Visit 1 that fulfils all of the following:
●
Severity consistent with need for surgery as defined by an endoscopic bilateral nasal polyp score (NPS) of at least 5 out of 8 and a minimum score of 2 in each nasal cavity at Visit 1 based on central reading, as well as reconfirmed at Visit 2 based on local reading.
●
Nasal congestion score (NCS) ≥ 2 at Visit 2.
●
Ongoing symptoms of CRSwNP for at least 8 weeks prior to Visit 1 such as rhinorrhea and/or reduction in smell.
4.
Participant has at least one of the following:
●
In the 24 months prior to Visit 1 , had a documented exacerbation of nasal polyposis requiring treatment with systemic corticosteroid, and/or;
●
A medical contraindication/intolerance to systemic corticosteroid, and/or;
●
Had prior surgery for NP (cannot be within 6 months prior to Visit 1 – see Section 5.2).
5.
Stable standard of care treatment for CRSwNP for at least 30 days prior to Visit 1 .
6.
At Visit 2, at least 21 days of background mometasone furoate nasal spray (MFNS) (or equivalent) background therapy.
7.
≥70% diary compliance for MFNS (or equivalent) in the 14 days prior to Visit 2.
Note: Compliance is verified based on MFNS (or equivalent) use recorded on the participant’s diary, with an expected dosing regimen of 2 actuations (50 μg/actuation) in each nostril, or equivalent, twice a day (for a total daily dose of 400 μg). If participant cannot tolerate, as determined at Visit 1 , the expected dosing regimen is 2 actuations (50 μg/actuation) in each nostril, once daily, for a total daily dose of 200 μg. Compliance will be calculated based on the number of doses taken (morning and evening) relative to the expected dosing regimen.
Contraceptive/Barrier Requirements
8.
Contraceptive use by the participant must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
NOTE: The reliability of sexual abstinence for participant enrollment eligibility needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.
Participants capable of producing sperm:
●
Agree to refrain from donating sperm during the intervention period and for a period of 120 days after the last dose of study intervention or after the Final Visit, whichever occurs last.
AND
●
Agree to follow the contraceptive guidance in Appendix 4 of this protocol during the intervention period and for a period of 120 days after the last dose of study intervention or after the Final Visit, whichever occurs last.
AND
●
Agree to use a condom when engaging in any activity that allows for passage of ejaculate to another person during the intervention period and for a period of 120 days after the last dose of study intervention or after the Final Visit, whichever occurs last.
Participants of childbearing potential:
●
Agree to refrain from donating eggs for a period of 120 days after the last dose of study intervention or after the Final Visit, whichever occurs last.
●
Participants are eligible to participate if they are not pregnant (see Appendix 4), not breastfeeding, and at least one of the following conditions applies:
●
Not a participant of childbearing potential (POCBP) as defined in Appendix 4;
OR
●
A POCBP who agrees to follow the contraceptive guidance in Appendix 4 during the intervention period and for 120 days after the last dose of study intervention or after the Final Visit, whichever occurs last.
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1.
Has undergone any intranasal and/or sinus surgery (including polypectomy) within 6 months prior to Visit 1 .
2.
Expected need, in the opinion of the investigator, for NP surgery within 12 weeks of Visit 2.
3.
Comorbid asthma having forced expiratory volume in 1 second (FEV1) 50% or less of predicted normal at Visit 1 .
4.
Conditions making participants non-evaluable at Visit 1 for the primary endpoint such as sino-nasal or sinus surgery changing the lateral wall structure of the nose, antrochoanal polyps, nasal septal deviation occluding at least one nostril, acute sinusitis, upper respiratory infection, ongoing rhinitis medicamentosa, fungal rhinosinusitis, nasal cavity benign or malignant tumors.
Prior/Concomitant Therapy
5.
Concurrent participation in a clinical study or has been treated with an investigational drug within 28 days or 5 half-lives, whichever is longer, prior to Visit 1 .
6.
Previous exposure to verekitug (UPB-101) or known allergy/sensitivity to any of its excipients.
7.
Biologic therapy or systemic immunosuppressant to treat inflammatory disease or autoimmune disease within 6 months or 5 half-lives before Visit 1 , whichever is longer, with the exception of oral corticosteroids. Treatment with cyclophosphamide and rituximab within 12 months of Visit 1 .
8.
Any experimental mAb within 5 half-lives or within 6 months before Visit 1 if the half-life was unknown.
9.
Leukotriene antagonists/modifiers at Visit 1 unless used as a continuous treatment at same dose for at least 30 days prior to Visit 1 .
10.
Allergen immunotherapy within 12 weeks (unless maintenance dose) prior to Visit 1 or plans to begin therapy or change dosing during the study.
Note: Stable maintenance doses of allergen immunotherapy within 12 weeks prior to Visit 1 are allowed.
11.
Administration of the T2 cytokine inhibitor suplatast tosilate within 15 days prior to Visit 1 .
12.
Oral, IV, or intramuscular steroid within 8 weeks prior to Visit 1 . Intrathecal or intra-articular steroids are permitted.
13.
Treatment with a live (attenuated) vaccine within 12 weeks before Visit 2.
14.
Any vaccination within the Screening Period.
15.
For participants with comorbid asthma, inhaled corticosteroid (ICS) total daily dose > 1000 μg fluticasone propionate (or equivalent dose of another ICS [Section 10.5]) or participants not on a stable dose of ICSs for ≥ 30 days prior to Visit 1 .
Concomitant Conditions and Disease
16.
Abnormal medical history, physical finding or safety finding that in the opinion of the Investigator may obscure the study data or interfere with the participant’s safety.
17.
Any clinical laboratory test result outside of the reference ranges considered by the Investigator as clinically significant and that may obscure the study data or interfere with the participant’s safety.
Note: Out of range screening values may be repeated one time per Investigator’s discretion.
18.
Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other dyskinetic ciliary syndromes, concomitant cystic fibrosis.
19.
Participant with comorbid asthma that also has a history or evidence of a clinically significant pulmonary condition (other than asthma), including significant restrictive findings on pulmonary function testing, chronic bronchitis, emphysema, bronchiectasis, pulmonary fibrosis, or any other related condition that may obscure the study data (e.g., gastro-esophageal reflux and vocal cord paralysis/dysfunction).
20.
Evidence of active or suspected bacterial, viral, fungal, or parasitic infections within 2 weeks prior to Visit 2 (e.g., sinusitis, common cold, viral syndrome, flu-like symptoms).
21.
History compatible with, or diagnosis of, a parasitic infection and has not been treated or has not responded to the standard of care therapy.
22.
Type I or II diabetes under poor glucose control, as assessed by the Investigator.
23.
Estimated glomerular filtration rate of < 60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration equation with correction factor for Black/African American participants.
Note: Non-clinically significant out of range value may be repeated one time per Investigator’s discretion.
24.
History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers, within 5 years before Visit 1 .
25.
Participant underwent surgery requiring general anesthesia within 8 weeks of Visit 1 , or surgery without full recovery within 4 weeks of Visit 1 , or donated blood or blood products, experienced loss of blood ≥500 mL or received blood products within 8 weeks of Visit 1 .
26.
Immunodeficiency disorder or positive for human immunodeficiency virus (HIV) antibodies.
27.
Positive hepatitis B surface antigen (HBsAg), or hepatitis C antibodies.
28.
Known active tuberculosis at Visit 1 . A tuberculosis test may be performed if required based on local guidelines.
29.
History of chronic alcohol or substance use disorder within 12 months prior to Visit 1 .
30.
Current tobacco smokers, nicotine vapers (including electronic cigarettes), snuff users or participants who have smoked and/or vaped and/or used snuff within the last 6 months prior to Visit 1 .
31.
Positive coronavirus disease 2019 (COVID-19) test within 28 days before Visit 1 .
Note: Participants with a positive COVID-19 test within 28 days before Visit 1 can be reassessed after a negative COVID-19 test is obtained.
32.
Pregnant or breastfeeding or planning to become pregnant or breastfeed during the study or unwilling to use adequate birth control, if of reproductive potential and sexually active.
Administrative
33.
Participant is an employee, consultant, and/or immediate family member (i.e., first degree relative, spouse, adoptee, or legal dependent) of the site or the Sponsor.
34.
Participant is unreliable; incapable of adhering to the protocol and visit schedule according to the judgement of the Investigator; or has any disorder that may compromise their ability to give informed consent.
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