Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03934216
• Collaborator: (none)
• Enrollment: 131
• Locations: 107
• Arms: 2
• Anticipated Duration (Months): 45.4
• Patients Per Site: 1.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: BMS-986165; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 131 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis
• Actual Study Start Date: Jul 1, 2019
• Actual Primary Completion Date: Jun 13, 2021
• Anticipated Study Completion Date: Apr 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986165	Drug: BMS-986165; Specified Dose on Specified Days; Other Names: Deucravacitinib
Placebo Comparator: Placebo	Other: Placebo; Specified Dose on Specified Days

Outcome Measures

Primary Outcome Measures

1. Clinical Remission Response Rate at Week 12 [From first dose to 12 weeks.]

   Clinical remission response rate is the percentage of participants achieving clinical remission, defined as absolute total Mayo Score and absolute Mayo endoscopy, stool frequency, rectal bleeding. Will be calculated using a modified Mayo score with the following: Stool Frequency (SF) subscore ≤ 1, with ≥ 1 point decrease from baseline, and Rectal Bleeding (RB) subscore = 0, and Endoscopic (ES) subscoreb ≤ 1 (modified, excludes friability) The modified Mayo score (0 to 9 points) is the sum of 3 components: the SF, RB, and ES subscores Modified Mayo Score: The modified Mayo score is a 9-point scale; a score of 5 to 9 points (inclusive), which is required for randomization, denotes moderate to severe disease (by protocol definition). considered in clinical remission if a Mayo Score of less than or equal to 2 with no individual subscore greater than 1

Secondary Outcome Measures

1. Clinical Response Rate at 12 Weeks [From first dose to 12 weeks]

   Clinical response is defined as percentage of participants with a reduction in total Mayo Score and reduction in rectal bleeding subscore Will be defined as the following: A decrease from baseline in the modified Mayo score of ≥ 2 points, and A decrease from baseline in the modified Mayo score ≥ 30%, and A decrease in rectal bleeding(RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1

2. Endoscopic Response at Week 12 [up to 12 Weeks]

   Endoscopic response will be defined as percentage of participants with a reduction in the total Ulcerative Colitis Endoscopic Index of Severity score. The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scale: Vascular Pattern: Normal (score 0) patchy obliteration (score 1) Obliterated (score 2) Bleeding None (score 0) Mucosal (score 1) Luminal mild (score 2) Luminal Moderate or severe (score 3) Erosions and Ulcers None (score 0) Erosions ( score 1) Superficial Ulcer (2) Deep Ulcer (score 3) A total score represents the following: remission (0-1); mild (2-4); moderate (5-6); and severe (7-8).

3. Histological Improvement Response Rate at 12 Weeks [up to 12 Weeks]

   Histologic improvement is defined as percentage of participants with a Geboes score of ≤ 3.1 Neutrophils <5% of crypts, with no crypt destruction, erosions, ulcerations, and granulation tissue. Achieving the following scores for the corresponding grades of the Geboes score: Score of 0 or 1 for Grade 3 (neutrophils in the epithelium: none or < 5% crypts involved), and Score of 0 for Grade 4 (crypt destruction: none), and Score of 0 Grade 5 (erosion or ulceration: no erosions, ulcerations, or granulation tissue) grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher score indicates more severe disease

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Must have active ulcerative colitis (UC) extending ≥ 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit

• Must have documented diagnosis of UC of at least 3 months' duration prior to screening

• Must have active moderate to severe UC, as defined by a modified Mayo score of 5 to 9 points, inclusive, which includes a stool frequency (SF) subscore of ≥ 2, and a rectal bleeding (RB) subscore ≥ 1, and a screening endoscopic (ES) subscore of ≥ 2

Exclusion Criteria:

• Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis, or pseudomembranous colitis (other than associated with Clostridium difficile [C. difficile])

• Stool positive for C. difficile toxin at screening visit

• Current or recent (within 12 weeks prior to the randomization visit) evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Connecticut Clinical Research Foundation	Bristol	Connecticut	United States	06010
2	University of Florida	Gainesville	Florida	United States	32610-0316
3	University of Florida	Gainesville	Florida	United States	32611
4	Advanced Research Institute - New Port Richey	New Port Richey	Florida	United States	34653
5	Local Institution - 0044	Sweetwater	Florida	United States	33172
6	Local Institution - 0011	Suwanee	Georgia	United States	30024
7	Illinois Gastroenterology Group	Glenview	Illinois	United States	60026
8	Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge	Baton Rouge	Louisiana	United States	70809
9	Local Institution - 0018	Shreveport	Louisiana	United States	71103
10	Local Institution - 0047	Chevy Chase	Maryland	United States	20815
11	Infusion Associates	Grand Rapids	Michigan	United States	49525
12	Mayo Clinic - Rochester	Rochester	Minnesota	United States	55905
13	Advanced Biomedical Research of America	Las Vegas	Nevada	United States	89119
14	Local Institution - 0049	Lake Success	New York	United States	11042
15	New York University Langone Medical Center	New York	New York	United States	10016
16	Consultants for Clinical Research	Cincinnati	Ohio	United States	45218
17	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
18	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
19	Medical University of South Carolina	Charleston	South Carolina	United States	29425
20	Rapid City Medical Center	Rapid City	South Dakota	United States	57701
21	Gastro One	Germantown	Tennessee	United States	38138
22	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
23	Local Institution - 0097	Garland	Texas	United States	75044
24	Local Institution - 0008	Houston	Texas	United States	77090
25	Gastroenterology Research of San Antonio	San Antonio	Texas	United States	78229
26	Southern Star Research Institute - Medical Center Office	San Antonio	Texas	United States	78229
27	Texas Digestive Disease Consultants - Southlake	Southlake	Texas	United States	76092
28	Tyler Research Institute	Tyler	Texas	United States	75701
29	Virginia Mason Medical Center	Seattle	Washington	United States	98101
30	Swedish First Hill Campus	Seattle	Washington	United States	98104
31	The Vancouver Clinic	Vancouver	Washington	United States	98664
32	Princess Alexandra Hospital	Woolloongabba	Queensland	Australia	4102
33	Local Institution - 0071	Bedford Park	South Australia	Australia	5042
34	Local Institution - 0108	Melbourne	Victoria	Australia	3181
35	Fiona Stanley Hospital	Murdoch	Western Australia	Australia	6150
36	Local Institution - 0039	Antwerpen		Belgium	2018
37	Local Institution - 0065	Brussels		Belgium	1000
38	Clinique du MontLegia - CHC	Liege		Belgium	4000
39	Hepato-Gastroenterology HK	Hradec Kralove		Czechia	500 12
40	Nemocnice Slany	Slany		Czechia	274 01
41	Centre Hospitalier Universitaire de Montpellier	Montpellier cedex 5		France	34295
42	Centre Hospitalier Lyon Sud	Pierre Benite Cedex		France	69495
43	Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord	Saint-Etienne		France	42055
44	Local Institution	Toulouse cedex 9		France	31059
45	Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum	Berlin		Germany	13353
46	Universitatsklinikum Carl Gustav Carus Dresden	Dresden		Germany	01307
47	Medizinische Hochschule Hannover	Hannover		Germany	30625
48	Universitaetsklinikum Schleswig-Holstein - Campus Kiel	Kiel		Germany	24105
49	Local Institution - 0062	Leipzig		Germany	04103
50	Universitatsklinik Ulm	Ulm		Germany	89081
51	Magyar Honvedseg-Egeszsegugyi Kozpont	Budapest		Hungary	1062
52	Local Institution - 0042	Budapest		Hungary	1088
53	Local Institution - 0024	Budapest		Hungary	1097
54	Debreceni Egyetem Klinikai Kozpont	Debrecen		Hungary	4032
55	Bugat Pal Korhaz	Gyongyos		Hungary	3200
56	Local Institution - 0033	Rozzano	Milano	Italy	20089
57	Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi	Bologna		Italy	40126
58	Local Institution - 0005	Catanzaro		Italy	88100
59	Clinica Medica Azienda Ospedaliera Universitaria	Messina		Italy	98125
60	Azienda Ospedaliera di Padova	Padova		Italy	35128
61	Fondazione IRCCS Policlinico San Matteo	Pavia		Italy	27100
62	Policlinico Universitario Campus Bio-Medico	Roma		Italy	00128
63	Fondazione Policlinico Tor Vergata	Roma		Italy	00133
64	Fondazione Policlinico Universitario Agostino Gemelli	Roma		Italy	00168
65	National Hospital Organization Hirosaki National Hospital	Hirosaki	Aomori	Japan	036-8545
66	Fukuoka University Chikushi Hospital	Chikushino	Fukuoka	Japan	818-8502
67	Local Institution - 0078	Kurume	Fukuoka	Japan	830-0011
68	National Hospital Organization Takasaki General Medical Center	Takasaki	Gunma	Japan	3700829
69	Hyogo College of Medicine Hospital	Nishinomiya	Hyogo	Japan	663-8501
70	Local Institution - 0081	Sagamihara-shi	Kanagawa	Japan	2520375
71	Shiga University of Medical Science Hospital	Otsu	Shiga	Japan	520-2192
72	Local Institution - 0066	Bunkyo-ku	Tokyo	Japan	113-8519
73	Local Institution - 0080	Minato-ku	Tokyo	Japan	105-8471
74	Saga University Hospital	Saga		Japan	849-8501
75	Local Institution - 0064	Daegu		Korea, Republic of	42415
76	Local Institution	Daegu		Korea, Republic of	700-712
77	Local Institution	Daegu		Korea, Republic of	700-721
78	Local Institution	Incheon		Korea, Republic of	22332
79	Local Institution	Seoul		Korea, Republic of	137-701
80	Local Institution	Seoul		Korea, Republic of	156-755
81	NZOZ Centrum Medyczne KERmed	Bydgoszcz		Poland	85-231
82	Local Institution - 0013	Bydgoszcz		Poland	85-794
83	Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi	Lodz		Poland	90-153
84	Local Institution - 0045	Lodz		Poland	90-302
85	Local Institution - 0098	Nowy Targ		Poland	34-400
86	TrialMed CRS - Piotrkow Trybunalski	Piotrkow Trybunalski		Poland	97-300
87	Endoskopia	Sopot		Poland	81-756
88	Local Institution - 0053	Szczecin		Poland	71-434
89	H-T. Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia	Tychy		Poland	43 100
90	Centrum Zdrowia Matki Dziecka i Mlodziezy	Warszawa		Poland	00-635
91	Local Institution - 0088	Warszawa		Poland	00-728
92	Local Institution - 0095	Warszawa		Poland	02-798
93	Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz	Warszawa		Poland	03-580
94	Local Institution - 0030	Warszawa		Poland	03-712
95	LexMedica	Wroclaw		Poland	53-114
96	Centrum Medyczne Oporow	Wroclaw		Poland	54-416
97	Nizhniy Novgorod Regional Clinical Hospital N.A. Semashko	Nizhniy Novgorod		Russian Federation	603126
98	Local Institution - 0020	Novosibirsk		Russian Federation	630005
99	Novosibirsk State Regional Clinical Hospital	Novosibirsk		Russian Federation	630087
100	Medical Center Healthy Family	Novosibirsk		Russian Federation	630099
101	Local Institution - 0015	Saratov		Russian Federation	410053
102	Multidisciplinary Consultative and Diagnostic Center	Tyumen		Russian Federation	625026
103	Barnsley Hospital NHS Foundation Trust	Barnsley		United Kingdom	S75 2EP
104	Cambridge University Hospitals NHS Foundation Trust	Cambridge		United Kingdom	CB2 2QQ
105	NHS Greater Glasgow and Clyde	Glasgow		United Kingdom	G51 4TF
106	Imperial College Healthcare NHS Trust	London		United Kingdom	W2 1NY
107	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield		United Kingdom	S10 2JF

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 14, 2021

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03934216
• Other Study ID Numbers: IM011-024; 2018-004694-27
• First Posted: May 1, 2019
• Last Update Posted: Jul 6, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer; BMS-986165

Study Results

Participant Flow

Pre-assignment Detail	131 Participants Randomized and 129 Treated

Arm/Group Title	Treatment	Placebo
Arm/Group Description	BMS-986-165 6mg BID	Placebo
Period Title: Randomization
STARTED	88	43
COMPLETED	87	42
NOT COMPLETED	1	1
Period Title: Randomization
STARTED	87	42
COMPLETED	69	35
NOT COMPLETED	18	7

Baseline Characteristics

Arm/Group Title	Treatment	Placebo	Total
Arm/Group Description	BMS-986-165 6mg BID	Placebo	Total of all reporting groups
Overall Participants	88	43	131
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	41.6 (14.81)	40.3 (13.91)	41.2 (14.48)
Sex: Female, Male (Count of Participants)
Female	40 45.5%	14 32.6%	54 41.2%
Male	48 54.5%	29 67.4%	77 58.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 3.4%	2 4.7%	5 3.8%
Not Hispanic or Latino	83 94.3%	41 95.3%	124 94.7%
Unknown or Not Reported	2 2.3%	0 0%	2 1.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 3.4%	7 16.3%	10 7.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 5.7%	2 4.7%	7 5.3%
White	80 90.9%	34 79.1%	114 87%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Clinical Remission Response Rate at Week 12
Description	Clinical remission response rate is the percentage of participants achieving clinical remission, defined as absolute total Mayo Score and absolute Mayo endoscopy, stool frequency, rectal bleeding. Will be calculated using a modified Mayo score with the following: Stool Frequency (SF) subscore ≤ 1, with ≥ 1 point decrease from baseline, and Rectal Bleeding (RB) subscore = 0, and Endoscopic (ES) subscoreb ≤ 1 (modified, excludes friability) The modified Mayo score (0 to 9 points) is the sum of 3 components: the SF, RB, and ES subscores Modified Mayo Score: The modified Mayo score is a 9-point scale; a score of 5 to 9 points (inclusive), which is required for randomization, denotes moderate to severe disease (by protocol definition). considered in clinical remission if a Mayo Score of less than or equal to 2 with no individual subscore greater than 1
Time Frame	From first dose to 12 weeks.

Outcome Measure Data

Analysis Population Description

All Randomized Participants

Arm/Group Title	Treatment	Placebo
Arm/Group Description	BMS-986-165 6mg BID	Placebo
Measure Participants	88	43
Number (95% Confidence Interval) [Percentage of Participants]	14.8 16.8%	16.3 37.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5935
	Comments
	Method	Stratified Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; 0.3 to 2.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Clinical Response Rate at 12 Weeks
Description	Clinical response is defined as percentage of participants with a reduction in total Mayo Score and reduction in rectal bleeding subscore Will be defined as the following: A decrease from baseline in the modified Mayo score of ≥ 2 points, and A decrease from baseline in the modified Mayo score ≥ 30%, and A decrease in rectal bleeding(RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1
Time Frame	From first dose to 12 weeks

Outcome Measure Data

Analysis Population Description

All Randomized Participants

Arm/Group Title	Treatment	Placebo
Arm/Group Description	BMS-986-165 6mg BID	Placebo
Measure Participants	88	43
Number (95% Confidence Interval) [Percentage of participants]	37.5 42.6%	32.6 75.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3051
	Comments
	Method	Stratified Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; 0.6 to 2.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Endoscopic Response at Week 12
Description	Endoscopic response will be defined as percentage of participants with a reduction in the total Ulcerative Colitis Endoscopic Index of Severity score. The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scale: Vascular Pattern: Normal (score 0) patchy obliteration (score 1) Obliterated (score 2) Bleeding None (score 0) Mucosal (score 1) Luminal mild (score 2) Luminal Moderate or severe (score 3) Erosions and Ulcers None (score 0) Erosions ( score 1) Superficial Ulcer (2) Deep Ulcer (score 3) A total score represents the following: remission (0-1); mild (2-4); moderate (5-6); and severe (7-8).
Time Frame	up to 12 Weeks

Outcome Measure Data

Analysis Population Description

All Randomized Participants

Arm/Group Title	Treatment	Placebo
Arm/Group Description	BMS-986-165 6mg BID	Placebo
Measure Participants	88	43
Number (95% Confidence Interval) [Percentage of Participants]	19.3 21.9%	27.9 64.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.8764
	Comments
	Method	Stratified Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.3 to 1.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Histological Improvement Response Rate at 12 Weeks
Description	Histologic improvement is defined as percentage of participants with a Geboes score of ≤ 3.1 Neutrophils <5% of crypts, with no crypt destruction, erosions, ulcerations, and granulation tissue. Achieving the following scores for the corresponding grades of the Geboes score: Score of 0 or 1 for Grade 3 (neutrophils in the epithelium: none or < 5% crypts involved), and Score of 0 for Grade 4 (crypt destruction: none), and Score of 0 Grade 5 (erosion or ulceration: no erosions, ulcerations, or granulation tissue) grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher score indicates more severe disease
Time Frame	up to 12 Weeks

Outcome Measure Data

Analysis Population Description

All Randomized Participants

Arm/Group Title	Treatment	Placebo
Arm/Group Description	BMS-986-165 6mg BID	Placebo
Measure Participants	88	43
Number (95% Confidence Interval) [Percentage of Participants]	21.6 24.5%	16.3 37.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2235
	Comments
	Method	Stratified Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 95%; 0.5 to 3.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Events occur on or after the first dose of study treatment through Week 12 or for participants who discontinue before Week 12 through 30 days after the final dose of the study treatment.
Arm/Group Title	Treatment		Placebo
Arm/Group Description	BMS-986-165 6mg BID		Placebo
All Cause Mortality
	Treatment		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/87 (1.1%)		0/42 (0%)
Serious Adverse Events
	Treatment		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/87 (9.2%)		2/42 (4.8%)
Blood and lymphatic system disorders
Anaemia	1/87 (1.1%)		0/42 (0%)
Gastrointestinal disorders
Colitis ulcerative	2/87 (2.3%)		2/42 (4.8%)
Constipation	1/87 (1.1%)		0/42 (0%)
Infections and infestations
Anal abscess	1/87 (1.1%)		0/42 (0%)
COVID-19	1/87 (1.1%)		0/42 (0%)
COVID-19 pneumonia	3/87 (3.4%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	Treatment		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/87 (26.4%)		2/42 (4.8%)
Gastrointestinal disorders
Colitis ulcerative	5/87 (5.7%)		1/42 (2.4%)
Skin and subcutaneous tissue disorders
Acne	8/87 (9.2%)		1/42 (2.4%)
Rash	10/87 (11.5%)		0/42 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.