Trial Outcomes & Findings for 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 (NCT NCT03695185)

Last Updated: 2023-03-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

At Week 8

Results posted on

2023-03-15

Participant Flow

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.

Prior to protocol version 4.0 this study was placebo-controlled. No participants were enrolled in the placebo group and therefore no results are presented for this arm.

Participant milestones

Participant milestones
Measure	Ravagalimab 600 mg/300 mg Participants received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg 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.
Induction Period (Week 0 to Week 12) STARTED	42
Induction Period (Week 0 to Week 12) COMPLETED	29
Induction Period (Week 0 to Week 12) NOT COMPLETED	13
Maintenance Period (Week 12 to Week 102) STARTED	29
Maintenance Period (Week 12 to Week 102) COMPLETED	1
Maintenance Period (Week 12 to Week 102) NOT COMPLETED	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Ravagalimab 600 mg/300 mg Participants received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg 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.
Induction Period (Week 0 to Week 12) Adverse Event	1
Induction Period (Week 0 to Week 12) Withdrew consent	2
Induction Period (Week 0 to Week 12) Lack of Efficacy	10
Maintenance Period (Week 12 to Week 102) Withdrew consent	3
Maintenance Period (Week 12 to Week 102) Lack of Efficacy	2
Maintenance Period (Week 12 to Week 102) Reason not specified	23

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ravagalimab 600 mg/ 300 mg n=42 Participants Participants received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg 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 EOW from Week 12 through Week 102.
Age, Continuous	42.3 years STANDARD_DEVIATION 14.41 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	39 Participants n=5 Participants
Race/Ethnicity, Customized Race · Non-White	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 8

Population: FAS included all enrolled participants who received at least 1 dose of ravagalimab. Data was reported only for the Induction Period.

Outcome measures

Outcome measures
Measure	Ravagalimab 600 mg/300 mg n=42 Participants Participants received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg SC at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period.
Percentage of Participants With Endoscopic Improvement During Induction Period	18.0 percentage of participants

SECONDARY outcome

Timeframe: At Week 8

Population: FAS included all enrolled participants who received at least 1 dose of ravagalimab and was used for all baseline and efficacy analyses. Data was reported only for the 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.

Outcome measures

Outcome measures
Measure	Ravagalimab 600 mg/300 mg n=42 Participants Participants received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg SC at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period.
Percentage of Participants With Clinical Remission Per Adapted Mayo Score During Induction Period	9.5 percentage of participants

SECONDARY outcome

Timeframe: At Week 8

Population: FAS included all enrolled participants who received at least 1 dose of ravagalimab. Data was reported only for the 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.

Outcome measures

Outcome measures
Measure	Ravagalimab 600 mg/300 mg n=42 Participants Participants received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg SC at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period.
Percentage of Participants With Clinical Response Per Adapted Mayo Score During Induction Period	40.2 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 8

Population: FAS included all enrolled participants who received at least 1 dose of ravagalimab. Data was reported only for the Induction Period.

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.

Outcome measures

Outcome measures
Measure	Ravagalimab 600 mg/300 mg n=42 Participants Participants received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg SC at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period.
Percentage of Participants With Clinical Response Per Partial Adapted Mayo Score	57.1 percentage of participants

SECONDARY outcome

Timeframe: At Week 8

Population: FAS included all enrolled participants who received at least 1 dose of ravagalimab. Overall number analysed is the number of participants available for analysis. Data was reported only for the Induction Period.

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.

Outcome measures

Outcome measures
Measure	Ravagalimab 600 mg/300 mg n=40 Participants Participants received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg SC at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period.
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 percentage of participants

SECONDARY outcome

Timeframe: At Week 8

Population: FAS included all enrolled participants who received at least 1 dose of ravagalimab. Data was reported only for the 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.

Outcome measures

Outcome measures
Measure	Ravagalimab 600 mg/300 mg n=42 Participants Participants received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg SC at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period.
Percentage of Participants With Endoscopic Remission During Induction Period	0.0 percentage of participants

Adverse Events

Induction Period: Ravagalimab 600 mg/300 mg

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Maintenance Period: Ravagalimab 300 mg

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Induction Period: Ravagalimab 600 mg/300 mg n=42 participants at risk Participants received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg SC at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period.	Maintenance Period: Ravagalimab 300 mg n=29 participants at risk 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 EOW from Week 12 through Week 102.
Gastrointestinal disorders COLITIS ULCERATIVE	2.4% 1/42 • Number of events 1 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/29 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations LARGE INTESTINE INFECTION	0.00% 0/42 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.4% 1/29 • Number of events 1 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations PERIRECTAL ABSCESS	2.4% 1/42 • Number of events 1 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/29 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/42 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.4% 1/29 • Number of events 1 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.

Other adverse events

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER

Measure	Induction Period: Ravagalimab 600 mg/300 mg n=42 participants at risk Participants received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg SC at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period.	Maintenance Period: Ravagalimab 300 mg n=29 participants at risk 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 EOW from Week 12 through Week 102.
Gastrointestinal disorders ABDOMINAL PAIN	2.4% 1/42 • Number of events 1 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.9% 2/29 • Number of events 2 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/42 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.9% 2/29 • Number of events 2 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders HAEMORRHOIDS	7.1% 3/42 • Number of events 3 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.4% 1/29 • Number of events 1 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders NAUSEA	7.1% 3/42 • Number of events 3 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.4% 1/29 • Number of events 1 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders FATIGUE	4.8% 2/42 • Number of events 7 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	10.3% 3/29 • Number of events 3 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders PYREXIA	4.8% 2/42 • Number of events 2 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	13.8% 4/29 • Number of events 5 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations COVID-19	0.00% 0/42 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	10.3% 3/29 • Number of events 3 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations TOOTH ABSCESS	0.00% 0/42 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.9% 2/29 • Number of events 2 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders IRON DEFICIENCY	2.4% 1/42 • Number of events 1 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.9% 2/29 • Number of events 2 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders VITAMIN D DEFICIENCY	0.00% 0/42 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.9% 2/29 • Number of events 2 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/42 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.7% 6/29 • Number of events 7 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders BACK PAIN	2.4% 1/42 • Number of events 1 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	10.3% 3/29 • Number of events 3 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders HEADACHE	4.8% 2/42 • Number of events 2 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	13.8% 4/29 • Number of events 4 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders PARAESTHESIA	2.4% 1/42 • Number of events 1 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	10.3% 3/29 • Number of events 4 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders ECZEMA	0.00% 0/42 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.9% 2/29 • Number of events 2 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders PRURITUS	2.4% 1/42 • Number of events 1 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	10.3% 3/29 • Number of events 3 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders RASH	7.1% 3/42 • Number of events 3 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.4% 1/29 • Number of events 1 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders SKIN LESION	0.00% 0/42 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.9% 2/29 • Number of events 2 • From first dose of study drug up to safety follow up visit (up to approximately 116 weeks) Safety Analysis Set included all participants who received at least 1 dose of study drug.