Eosinophilic Esophagitis (EoE)Phase 2NCT06598462
A Study to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis
A Phase 2 study testing Solrikitug Low Dose, Solrikitug Mid Dose and Solrikitug High Dose in people with Eosinophilic Esophagitis (EoE), run by Uniquity One (UNI) at 73 sites in 9 countries.
Trial summary
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solrikitug in adult participants with eosinophilic esophagitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Eosinophilic Esophagitis (EoE)
- What is being tested?
- Solrikitug Low Dose, Solrikitug Mid Dose and Solrikitug High Dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 73 sitesin 9 countries
- Study dates
- 16 Oct 2024to 31 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part A
- Participant must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
- Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming diagnosis of EoE.
- Participants who have symptomatic EoE as defined by a history of on average at least 2 episodes of dysphagia per week in the 4 weeks prior to Screening.
- Must remain on a stabilized diet for at least 8 weeks prior to Visit 1 and during the course of the study.
- May be on any background PPI and/or STC, during the course of the study, as long as background medications have been stable for at least 8 weeks prior to the Screening and must agree to no changes to background medication or dosage unless medically indicated.
- Discontinuation of any marketed investigational drug or biologic (monoclonal or polyclonal antibody) within 30 days or 5 half-lives prior to screening, whichever is longer.
- Participants should have previously documented standard of care treatment, which could include PPI and/or STC and/or diet.
Who cannot join
- Part A
- Female participant who is pregnant or breastfeeding.
- Have a history or presence of any other gastrointestinal disorders such as active Helicobacter pylori infection, history of achalasia, hyper eosinophilic syndrome and eosinophilic granulomatosis with polyangiitis, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, celiac disease, eosinophilic enteritis, gastritis, colitis, diverticulitis, irritable bowel syndrome, or other clinically significant gastrointestinal conditions as per Investigator discretion.
- Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation at screening.
- Esophageal dilation performed within 8 weeks prior to screening.
- 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.
Show all 11Show fewer
- Part B
- Participants who, during Part A, developed a serious adverse event (SAE) and/or adverse event (AE) deemed related to study drug, which in the opinion of the investigator could indicate that continued treatment with study drug may present and unreasonable risk to the participant.
- Participants who became pregnant during Part A.
- Participants who are prematurely discontinued from study drug due to AE (patients who are prematurely discontinued from study drug due to lack of efficacy are eligible to enter Part B).
- Patients who did not undergo endoscopy with biopsies prior to receiving rescue treatment.
Trial locations and contacts
73 sites in 9 countries.
73 sites in 9 countries
United States38 sites
Research Site 1024
Ann Arbor, Michigan, 48109
Research Site 1034
Aurora, Colorado, 80045
Research Site 1007
Boise, Idaho, 83706
Research Site 1004
Boston, Massachusetts, 02111
Research Site 1026
Chapel Hill, North Carolina, 27599
Research Site 1032
Chevy Chase, Maryland, 20815
Research Site 1012
Columbus, Ohio, 43213
Research Site 1042
Creve Coeur, Missouri, 63141
Research Site 1027
Cromwell, Connecticut, 06416
Research Site 1014
Dallas, Texas, 75230
Research Site 1039
Dothan, Alabama, 36305
Research Site 1023
Englewood, California, 90301
Research Site 1045
Freehold, New Jersey, 07728
Research Site 1018
Glendale, Arizona, 85306
Research Site 1048
Glenview, Illinois, 60026
Research Site 1020
Harrisburg, Pennsylvania, 17110
Research Site 1021
High Point, North Carolina, 27265
Research Site 1008
Houston, Texas, 77494
Research Site 1040
Inverness, Florida, 34452
Research Site 1022
Iowa City, Iowa, 52242
Research Site 1005
Irvine, California, 92618
Research Site 1043
Jackson, New Jersey, 08527
Research Site 1001
Jacksonville, Florida, 32256
Research Site 1049
Miami, Florida, 33155
Research Site 1002
Ogden, Utah, 84405
Research Site 1036
Pearland, Texas, 77584
Research Site 1018
Peoria, Arizona, 85306
Research Site 1030
Philadelphia, Pennsylvania, 19104
Research Site 1006
Plymouth, Minnesota, 55446
Research Site 1016
Reno, Nevada, 89511
Research Site 1041
Rockwell, Texas, 75032
Research Site 1019
Salt Lake City, Utah, 84132
Research Site 1015
San Diego, California, 92120
Research Site 1017
Sandy City, Utah, 84092
Research Site 1037
Scottsdale, Arizona, 85258
Research Site 1033
Topeka, Kansas, 66606
Research Site 1003
Tucson, Arizona, 85715
Research Site 1013
Wyoming, Michigan, 49519
Australia10 sites
Research Site 1106
Box Hill, Victoria, 3128
Research Site 1102
Fitzroy, Victoria, 3065
Research Site 1110
Maroochydore, Queensland, 4558
Research Site 1111
Maroochydore, QLD 4558
Research Site 1109
Murdoch, Western AUS, 6050
Research Site 1108
Newcastle, New South Wales, 02111
Research Site 1101
Parkville, Victoria, 3010
Research Site 1103
South Brisbane, Queensland, 4101
Research Site 1107
Woolloongabba, Queensland, 4102
Research Site 1107
Woolloongabba, QLD 4102
Poland7 sites
Research Site 1207
Lodz, 90-752
Research Site 1202
Szczecin, 04-501
Research Site 1205
Tychy, 43-100
Research Site 1203
Warsaw, 00-189
Research Site 1206
Warsaw, 02-781
Research Site 1204
Warsaw, 04-141
Research Site 1201
Warsaw, 04-501
Italy6 sites
Research Site 1256
Campobasso, IT, 86100
Research Site 1252
Milan, Ca'Granada, 20122
Research Site 1253
Padova, IT, 35128
Research Site 1259
Pieve Emanuele, MI, 20072
Research Site 1255
Roma, IT, 00168
Research Site 1258
Verona, 37134
Spain4 sites
Research Site 1354
Barcelona, 08022
Research Site 1353
Madrid, 28006
Research Site 1352
Madrid, 28040
Research Site 1351
Tomelloso, 13700
Belgium3 sites
Research Site 1152
Bruges, 8310
Research Site 1151
Leuven, VLG, 3000
Research Site 1153
Tournai, 7500
Netherlands2 sites
Research Site 1303
Maastricht, AZ, 6202
Research Site 1302
Rotterdam, 3000
United Kingdom2 sites
Research Site 1553
London, Tooting, SW17 0GT
Research Site 1551
Whitechapel, London, E1 1BB
About this study
Official title: A Phase 2, Randomized, Double-Blind, Multicenter, Placebo Controlled Study With an Extension to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis (ALAMERE)
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solrikitug in adult participants with eosinophilic esophagitis.
Read the detailed description
This is a 24-week randomized, double-blind, placebo-controlled Phase 2 clinical study with a 28-week extension to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of 3 dose levels of solrikitug versus placebo on top of standard of care in adult participants with EoE.
Approximately 180 adult participants with EoE will be randomized at approximately 80 sites. Participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 24-week treatment period followed by a 28-week extension period. The study also includes a post-treatment follow-up period of 16 weeks.
- Conditions
- Eosinophilic Esophagitis (EoE)
- Being tested
- Solrikitug Low Dose, Solrikitug Mid Dose, Solrikitug High Dose, Placebo
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solrikitug Low DoseBiological
Solrikitug low dose subcutaneous injection
Solrikitug Mid DoseBiological
Solrikitug mid dose subcutaneous injection
Solrikitug High DoseBiological
Solrikitug high dose subcutaneous injection
PlaceboOther
Placebo subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Solrikitug low dose | Experimental | Solrikitug Receives: Biological: Solrikitug Low Dose |
| Solrikitug mid dose | Experimental | Solrikitug Receives: Biological: Solrikitug Mid Dose |
| Solrikitug high dose | Experimental | Solrikitug Receives: Biological: Solrikitug High Dose |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological response of peak esophageal eosinophil per HPF count of ≤6
Measured: Week 24
Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score
The DSQ score is calculated over 14-day period and ranges from 0 to 84, with a lower score indicating less severe dysphagia.
Measured: Week 24
Secondary outcomes (1)
Adverse events (AEs) and serious adverse events (SAEs)
Measured: To Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Oct 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Esophagitis (EoE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniquity One (UNI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew W Lee, MD, Study chair, Vice President, Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598462
- Sponsor's protocol ID
- NSI-8226-201
- Status last verified
- Mar 2026
- First submitted
- 13 Sep 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Multicenter, Placebo Controlled Study With an Extension to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis (ALAMERE)
- ClinicalTrials.gov ID
- NCT06598462
- Acronym / sponsor ID
- NSI-8226-201
- Conditions
- Eosinophilic Esophagitis (EoE)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Uniquity One (UNI)Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solrikitug in adult participants with eosinophilic esophagitis.
Detailed description
This is a 24-week randomized, double-blind, placebo-controlled Phase 2 clinical study with a 28-week extension to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of 3 dose levels of solrikitug versus placebo on top of standard of care in adult participants with EoE.
Approximately 180 adult participants with EoE will be randomized at approximately 80 sites. Participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 24-week treatment period followed by a 28-week extension period. The study also includes a post-treatment follow-up period of 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Solrikitug low dose | Experimental | Biological: Solrikitug Low DoseSolrikitug |
| Solrikitug mid dose | Experimental | Biological: Solrikitug Mid DoseSolrikitug |
| Solrikitug high dose | Experimental | Biological: Solrikitug High DoseSolrikitug |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Part A
- Participant must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
- Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming diagnosis of EoE.
- Participants who have symptomatic EoE as defined by a history of on average at least 2 episodes of dysphagia per week in the 4 weeks prior to Screening.
- Must remain on a stabilized diet for at least 8 weeks prior to Visit 1 and during the course of the study.
Key exclusion criteria (11 listed)
- Part A
- Female participant who is pregnant or breastfeeding.
- Have a history or presence of any other gastrointestinal disorders such as active Helicobacter pylori infection, history of achalasia, hyper eosinophilic syndrome and eosinophilic granulomatosis with polyangiitis, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, celiac disease, eosinophilic enteritis, gastritis, colitis, diverticulitis, irritable bowel syndrome, or other clinically significant gastrointestinal conditions as per Investigator discretion.
- Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation at screening.
- Esophageal dilation performed within 8 weeks prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solrikitug Low DoseSolrikitug low dose subcutaneous injection | Biological | Solrikitug low dose |
| Solrikitug Mid DoseSolrikitug mid dose subcutaneous injection | Biological | Solrikitug mid dose |
| Solrikitug High DoseSolrikitug high dose subcutaneous injection | Biological | Solrikitug high dose |
| PlaceboPlacebo subcutaneous injection | Other | Placebo |
Primary outcome
Histological response of peak esophageal eosinophil per HPF count of ≤6
Time frame: Week 24
Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score
Time frame: Week 24
The DSQ score is calculated over 14-day period and ranges from 0 to 84, with a lower score indicating less severe dysphagia.
1 secondary outcome
Adverse events (AEs) and serious adverse events (SAEs)
Time frame: To Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew W Lee, MD study chair
Vice President, Clinical Research
73 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Solrikitug Low Dose, Solrikitug Mid Dose and Solrikitug High Dose in people with Eosinophilic Esophagitis (EoE), run by Uniquity One (UNI) at 73 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in United States, Australia, Poland, Italy, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological response of peak esophageal eosinophil per HPF count of ≤6 (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.