Ulcerative Colitis (UC)Phase 2NCT03695185
A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
A Phase 2 study testing Ravagalimab 600 mg and Ravagalimab 300 mg in people with Ulcerative Colitis (UC), run by AbbVie at 34 sites in 10 countries.
Trial summary
Study M15-722 is a Phase 2a study to investigate the efficacy and safety of Ravagalimab (ABBV-323) in participants with moderate to severe UC who failed prior therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- Ravagalimab 600 mg and Ravagalimab 300 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 34 sitesin 10 countries
- Study dates
- 26 Mar 2019to 10 Jan 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
- Diagnosis of UC for at least 3 months prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the Investigator, must be available.
- Participant meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review).
- History of inadequate response, loss of response, or intolerance to one or more of the approved biologic therapies: infliximab, adalimumab, golimumab, vedolizumab, and/or tofacitinib (Note: If tofacitinib was received in a clinical trial, subject must have received open-label drug).
Who cannot join
- Participant having an active, chronic, or recurrent infection that based on Investigator's clinical assessment makes the participant an unsuitable candidate for the study.
- Participant having any malignancy except for successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
- Participant with history of dysplasia of the gastrointestinal tract or evidence of dysplasia in any biopsy performed during the screening endoscopy other than completely removed low-grade dysplastic lesions.
- Laboratory values not meeting the following criteria : Serum aspartate transaminase (AST) and alanine transaminase (ALT) <= 2* upper limit of normal (ULN); Total white blood cell (WBC) count >= 3.0*10^9/L.
Trial locations and contacts
34 sites in 10 countries.
34 sites in 10 countries
United States12 sites
Univ New Mexico /ID# 208817
Albuquerque, New Mexico, 87131
The University of Chicago DCAM /ID# 207086
Chicago, Illinois, 60637
Meridian Investigator Network /ID# 204646
Huntington Beach, California, 92648-5994
Meridian Investigator Network /ID# 218568
Lakewood, California, 90712
TLC Clinical Research Inc /ID# 206626
Los Angeles, California, 90048
Orange County Institute of Gastroenterology and Endoscopy /ID# 207405
Mission Viejo, California, 92691-6306
Vanderbilt University Medical Center /ID# 204670
Nashville, Tennessee, 37232-0011
Affinity Clinical Research /ID# 206211
Oak Brook, Illinois, 60523-1245
Penn Presbyterian Medical Center /ID# 206826
Philadelphia, Pennsylvania, 19104-2640
UC Davis Medical Center /ID# 209402
Sacramento, California, 95817
Clinical Associates in Research Therapeutics of America, LLC /ID# 204689
San Antonio, Texas, 78212
Banner University Medical Cent /ID# 208392
Tucson, Arizona, 85724
France3 sites
Hopital Beaujon /ID# 208129
Clichy, Île-de-France Region, 92110
Chu de Nice-Hopital L'Archet Ii /Id# 208131
Nice, Alpes-Maritimes, 06200
CHRU Nancy - Hôpitaux de Brabois /ID# 208133
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500
Germany3 sites
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 207570
Berlin, 10117
Universitaetsklinikum Frankfurt /ID# 207569
Frankfurt am Main, Hesse, 60590
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 207571
Kiel, Schleswig-Holstein, 24105
Italy3 sites
University of Catanzaro /ID# 204546
Catanzaro, Calabria, 88100
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 208504
Milan, 20122
Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 204549
Rome, Roma, 00168
Netherlands3 sites
Maastricht Universitair Medisch Centrum /ID# 204428
Maastricht, 6229 HX
Franciscus Gasthuis & Vlietland /ID# 206976
Rotterdam, 3045 PM
Elisabeth Tweesteden Ziekenhuis /ID# 206272
Tilburg, 5022 GC
Spain3 sites
Hospital Santa Creu i Sant Pau /ID# 213259
Barcelona, 08041
Hospital General Universitario Gregorio Maranon /ID# 204504
Madrid, 28007
Hospital Universitario La Paz /ID# 210065
Madrid, 28046
Hungary2 sites
Debreceni Egyetem Klinikai Kozpont /ID# 221952
Debrecen, 4032
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221576
Szeged, Csongrád megye, 6725
South Korea2 sites
Kyungpook National University Hospital /ID# 209912
Daegu, 41944
Yeungnam University Medical Center /ID# 210447
Daegu, 42415
United Kingdom2 sites
Belfast Health and Social Care Trust /ID# 206744
Belfast, BT9 7AB
NHS Greater Glasgow and Clyde /ID# 206574
Glasgow, Scotland, G12 0XH
About this study
Official title: A Multicenter, Single Arm, Open-label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
Study M15-722 is a Phase 2a study to investigate the efficacy and safety of Ravagalimab (ABBV-323) in participants with moderate to severe UC who failed prior therapy.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- Ravagalimab 600 mg, Ravagalimab 300 mg
- Keywords
- Ulcerative Colitis (UC), ABBV-323, Ravagalimab
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ravagalimab 600 mgDrug
Also called ABBV-323
Ravagalimab 600 mg was administered intravenously (IV).
Ravagalimab 300 mgDrug
Also called ABBV-323
Ravagalimab 300 mg was administered subcutaneously (SC).
| Study group | Role | What they receive |
|---|---|---|
| Ravagalimab 600 mg/300 mg | Experimental | Participants received ravagalimab 600 mg intravenous (IV) at Week 0 followed by ravagalimab 300 mg subcutaneously (SC) at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period. Participants who achieved clinical response per partial adapted Mayo score at Week 12 of the Induction Period entered the Maintenance Period to receive ravagalimab 300 mg SC every other week (EOW) from Week 12 through Week 102. Receives: Drug: Ravagalimab 600 mg; Drug: Ravagalimab 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Endoscopic Improvement During Induction Period
Endoscopic Improvement is defined as Mayo endoscopic subscore of 0 or 1. Mayo endoscopic score is classified as 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern); 2=Moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Higher score indicates worsening of the disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
Measured: At Week 8
Secondary outcomes (5)
Percentage of Participants With Clinical Remission Per Adapted Mayo Score During Induction Period
Clinical remission per Adapted Mayo score is defined as stool frequency subscore (SFS) <=1, and not greater than baseline, rectal bleeding subscore (RBS) = 0, and endoscopic subscore <=1. The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal), Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed), Endoscopic subscore confirmed by central reader, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
Measured: At Week 8
Percentage of Participants With Clinical Response Per Adapted Mayo Score During Induction Period
Clinical response per Adapted Mayo score is defined as the decrease from Baseline >= 2 points and >= 30%, PLUS a decrease in RBS >=1 or an absolute RBS <=1. The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal), Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed), Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
Measured: At Week 8
Percentage of Participants With Clinical Response Per Partial Adapted Mayo Score
Clinical response per Partial Adapted Mayo score is defined as decrease from baseline >=1 points and >=30%, PLUS a decrease in RBS >= 1 or an absolute RBS <=1. The Partial Adapted Mayo Score is a composite score of UC disease activity based on the following 2 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). The overall Partial Adapted Mayo score ranges from 0 to 6 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
Measured: Up to Week 8
Percentage of Participants With Clinical Remission Per Full Mayo Score During Induction Period in Participants With a Full Mayo Score of 6 to 12 at Baseline
Clinical Remission per full Mayo score is defined as Full Mayo score <=2 with no subscore > 1. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Endoscopies were assessed by a central reader. Negative changes indicate improvement. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to the nearest whole integer.
Measured: At Week 8
Percentage of Participants With Endoscopic Remission During Induction Period
Endoscopic remission is defined as Mayo endoscopic subscore = 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). Higher score indicates worsening of the disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to the nearest whole integer.
Measured: At Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start26 Mar 2019
- Primary completion5 Apr 2021
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695185
- Sponsor's protocol ID
- M15-722
- Other IDs
- 2018-000930-37, 2018
- Status last verified
- Feb 2023
- First submitted
- 2 Oct 2018
- Last updated
- 15 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Publications
Peyrin-Biroulet L, Seenan JP, Armuzzi A, Lazar A, Eldred A, Doan T, Polakow SB, Al Mahi N, Liu M, Nader A, Bhatnagar S, Schreiber S. Efficacy and Safety of Ravagalimab in Patients with Moderate-to-Severe Ulcerative Colitis: Data from a Phase 2a Trial. Adv Ther. 2026 Jun;43(6):2611-2630. doi: 10.1007/s12325-026-03517-3. Epub 2026 Apr 1.
PubMed 41920263
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single Arm, Open-label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
- ClinicalTrials.gov ID
- NCT03695185
- Acronym / sponsor ID
- M15-722
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- Ulcerative Colitis (UC), ABBV-323, Ravagalimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 5 Apr 2021 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Posted 15 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study M15-722 is a Phase 2a study to investigate the efficacy and safety of Ravagalimab (ABBV-323) in participants with moderate to severe UC who failed prior therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ravagalimab 600 mg/300 mg | Experimental | Drug: Ravagalimab 600 mg, Drug: Ravagalimab 300 mgParticipants received ravagalimab 600 mg intravenous (IV) at Week 0 followed by ravagalimab 300 mg subcutaneously (SC) at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period. Participants who achieved clinical response per partial adapted Mayo score at Week 12 of the Induction Period entered the Maintenance Period to receive ravagalimab 300 mg SC every other week (EOW) from Week 12 through Week 102. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
- Diagnosis of UC for at least 3 months prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the Investigator, must be available.
- Participant meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review).
- History of inadequate response, loss of response, or intolerance to one or more of the approved biologic therapies: infliximab, adalimumab, golimumab, vedolizumab, and/or tofacitinib (Note: If tofacitinib was received in a clinical trial, subject must have received open-label drug).
Key exclusion criteria (4 listed)
- Participant having an active, chronic, or recurrent infection that based on Investigator's clinical assessment makes the participant an unsuitable candidate for the study.
- Participant having any malignancy except for successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
- Participant with history of dysplasia of the gastrointestinal tract or evidence of dysplasia in any biopsy performed during the screening endoscopy other than completely removed low-grade dysplastic lesions.
- Laboratory values not meeting the following criteria : Serum aspartate transaminase (AST) and alanine transaminase (ALT) <= 2* upper limit of normal (ULN); Total white blood cell (WBC) count >= 3.0*10^9/L.
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 |
|---|---|---|
| Ravagalimab 600 mgAlso: ABBV-323Ravagalimab 600 mg was administered intravenously (IV). | Drug | Ravagalimab 600 mg/300 mg |
| Ravagalimab 300 mgAlso: ABBV-323Ravagalimab 300 mg was administered subcutaneously (SC). | Drug | Ravagalimab 600 mg/300 mg |
Primary outcome
Percentage of Participants With Endoscopic Improvement During Induction Period
Time frame: At Week 8
Endoscopic Improvement is defined as Mayo endoscopic subscore of 0 or 1. Mayo endoscopic score is classified as 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern); 2=Moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Higher score indicates worsening of the disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
5 secondary outcomes
Percentage of Participants With Clinical Remission Per Adapted Mayo Score During Induction Period
Time frame: At Week 8
Percentage of Participants With Clinical Response Per Adapted Mayo Score During Induction Period
Time frame: At Week 8
Percentage of Participants With Clinical Response Per Partial Adapted Mayo Score
Time frame: Up to Week 8
Percentage of Participants With Clinical Remission Per Full Mayo Score During Induction Period in Participants With a Full Mayo Score of 6 to 12 at Baseline
Time frame: At Week 8
Percentage of Participants With Endoscopic Remission During Induction Period
Time frame: At Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41920263Peyrin-Biroulet L, Seenan JP, Armuzzi A, Lazar A, Eldred A, Doan T, Polakow SB, Al Mahi N, Liu M, Nader A, Bhatnagar S, Schreiber S. Efficacy and Safety of Ravagalimab in Patients with Moderate-to-Severe Ulcerative Colitis: Data from a Phase 2a Trial. Adv Ther. 2026 Jun;43(6):2611-2630. doi: 10.1007/s12325-026-03517-3. Epub 2026 Apr 1.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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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.
ABBVIE INC. study director
AbbVie
34 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ravagalimab 600 mg and Ravagalimab 300 mg in people with Ulcerative Colitis (UC), run by AbbVie at 34 sites in 10 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, France, Germany, Italy, Netherlands and 5 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. 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?
Yes. Results are posted in the registry (first posted 15 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Endoscopic Improvement During Induction Period (time frame: At Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03695185, which also lists 1 linked publication.
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 15 Mar 2023.