A Phase 2 interventional study of Ravagalimab 600 mg and Ravagalimab 300 mg in Ulcerative Colitis (UC), sponsored by AbbVie. Completed at 34 sites in 10 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-15.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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.
1,074 studies on the registry are indexed under Colitis; 133 are open to participants now.
This study's enrollment of 42 is below the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Ravagalimab 600 mg · Drug: Ravagalimab 300 mg
Ravagalimab 600 mg was administered intravenously (IV).
Also known as: ABBV-323
Ravagalimab 300 mg was administered subcutaneously (SC).
Also known as: ABBV-323
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.
Time frame: At Week 8
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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: At Week 8
A total of 42 participants were enrolled in the Induction Period to receive ravagalimab 600 mg intravenously (IV) followed by ravagalimab 300 mg subcutaneously (SC) up to Week 12. Participants who completed the Induction Period and achieved clinical response per partial adapted Mayo score at Week 12 entered the Maintenance Period to receive ravagalimab 300 mg SC up to Week 102.
| Milestone | Ravagalimab 600 mg/300 mg |
|---|---|
| Started | 42 |
| Completed | 29 |
| Not completed | 13 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrew consent | 2 |
| Withdrew: Lack of efficacy | 10 |
| Milestone | Ravagalimab 600 mg/300 mg |
|---|---|
| Started | 29 |
| Completed | 1 |
| Not completed | 28 |
| Withdrew: Withdrew consent | 3 |
| Withdrew: Lack of efficacy | 2 |
| Withdrew: Reason not specified | 23 |
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.
| percentage of participants | Ravagalimab 600 mg/300 mg |
|---|---|
| Percentage of Participants With Endoscopic Improvement During Induction Period | 18.0 |
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.
| percentage of participants | Ravagalimab 600 mg/300 mg |
|---|---|
| Percentage of Participants With Clinical Remission Per Adapted Mayo Score During Induction Period | 9.5 |
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.
| percentage of participants | Ravagalimab 600 mg/300 mg |
|---|---|
| Percentage of Participants With Clinical Response Per Adapted Mayo Score During Induction Period | 40.2 |
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.
| percentage of participants | Ravagalimab 600 mg/300 mg |
|---|---|
| Percentage of Participants With Clinical Response Per Partial Adapted Mayo Score | 57.1 |
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.
| percentage of participants | Ravagalimab 600 mg/300 mg |
|---|---|
| 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 | 7.5 |
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.
| percentage of participants | Ravagalimab 600 mg/300 mg |
|---|---|
| Percentage of Participants With Endoscopic Remission During Induction Period | 0.0 |
Collected over From first dose of study drug up to safety follow up visit (up to approximately 116 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Induction Period: Ravagalimab 600 mg/300 mg | 0/42 (0%) | 2/42 (4.8%) | 15/42 (35.7%) |
| Maintenance Period: Ravagalimab 300 mg | 0/29 (0%) | 2/29 (6.9%) | 19/29 (65.5%) |
| Event | Induction Period: Ravagalimab 600 mg/300 mg | Maintenance Period: Ravagalimab 300 mg |
|---|---|---|
| LARGE INTESTINE INFECTIONInfections and infestations | 0/42 | 1/29 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 0/42 | 1/29 |
| COLITIS ULCERATIVEGastrointestinal disorders | 1/42 | 0/29 |
| PERIRECTAL ABSCESSInfections and infestations | 1/42 | 0/29 |
| Event | Induction Period: Ravagalimab 600 mg/300 mg | Maintenance Period: Ravagalimab 300 mg |
|---|---|---|
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 0/42 | 6/29 |
| PYREXIAGeneral disorders | 2/42 | 4/29 |
| HEADACHENervous system disorders | 2/42 | 4/29 |
| FATIGUEGeneral disorders | 2/42 | 3/29 |
| COVID-19Infections and infestations | 0/42 | 3/29 |
| BACK PAINMusculoskeletal and connective tissue disorders | 1/42 | 3/29 |
| PARAESTHESIANervous system disorders | 1/42 | 3/29 |
| PRURITUSSkin and subcutaneous tissue disorders | 1/42 | 3/29 |
| HAEMORRHOIDSGastrointestinal disorders | 3/42 | 1/29 |
| NAUSEAGastrointestinal disorders | 3/42 | 1/29 |
Full Analysis Set (FAS) included all enrolled participants who received at least 1 dose of ravagalimab and was used for all baseline and efficacy analyses.
| Age, Continuous(years) | Ravagalimab 600 mg/ 300 mg |
|---|---|
| Mean | 42.3 ± 14.41 |
| Sex: Female, Male(Participants) | Ravagalimab 600 mg/ 300 mg |
|---|---|
| Female | 17 |
| Male | 25 |
| Ethnicity (NIH/OMB)(Participants) | Ravagalimab 600 mg/ 300 mg |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 37 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | Ravagalimab 600 mg/ 300 mg |
|---|---|
| Race — White | 39 |
| Race — Non-White | 3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Csr
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