A Trial to Evaluate the Efficacy and Safety of Different... | NCT05055258

Label	Type	Description	Intervention Names
300 mg KVD824	Experimental	300 mg KVD824 twice a day for 12 weeks	Drug: KVD824
600 mg KVD824	Experimental	Two 300 mg KVD824 tablets twice a day for 12 weeks	Drug: KVD824
900 mg KVD824	Experimental	Three 300 mg KVD824 tablets twice a day for 12 weeks	Drug: KVD824
Placebo to KVD824	Placebo Comparator	One, two or three placebo tablets to be taken twice a day for 12 weeks	Drug: Placebo to KVD824

Name	Type	Description	Arm Group Labels	Other Names
KVD824	Drug	KVD824 300 mg Modified-Release Tablets	300 mg KVD824 600 mg KVD824 900 mg KVD824

Measure	Description	Time Frame
The Rate of Investigator-confirmed HAE Attacks During the Treatment Period	To examine the number of investigator-confirmed attacks whilst on treatment compared to placebo. Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.	12 weeks

Measure	Description	Time Frame
Proportion of Subjects Without Investigator-confirmed HAE Attacks During the Treatment Period.	Logistic regression on subjects were measured without investigator-confirmed HAE Attacks (FAS). Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.	12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female subjects 18 years of age and older.
Confirmed diagnosis of HAE type I or II at any time in the medical history:
1. Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria) AND EITHER
2. Diagnostic testing results obtained prior to randomization that confirm HAE Type I or II: C1-INH functional level <40% of the normal level. Subjects with functional C1-INH level 40-50% of the normal level may be enrolled if they also have a C4 level below the normal range. Testing may be obtained from central or local laboratories or obtained from documented historical testing results. Subjects may be restested at anytime prior to randomization if results are incongruent with clinical history or believed by the Investigator to be confounded by recent prophylactic or therapeutic C1 INH use, OR
3. Documented genetic results that confirm known mutations for HAE Type I or II.
Subject has access to and ability to use conventional treatment for HAE attacks.
Subject is willing to cease any current medications being taken for HAE prophylaxis and Investigator determines that doing so would not place the subject at any undue safety risk.
Subject's last dose of attenuated androgens was at least 28 days prior to first dose of IMP.
During the Run-in Period subject meets one of the following criteria:
1. Two Investigator-confirmed attacks in the first 4-week period.
2. Three Investigator-confirmed attacks in ≤8 weeks.
Subjects who are fertile and heterosexually active must adhere to contraception requirements throughout the trial as follows:

a) Female subjects must agree to use at least one highly effective contraception method from the Screening Visit until the end of the trial. Highly effective methods of contraception include: i) Progestogen-only hormonal contraception associated with inhibition of ovulation: oral/injectable/implantable (hormonal contraception that contains estrogen including ethinylestradiol is excluded per Exclusion 4).

ii) Intrauterine device (IUD). iii) Intrauterine hormone-releasing system (IUS). iv) Bilateral tubal occlusion. v) Vasectomized partner (provided that the partner is the sole sexual partner of the female subject of childbearing potential and that the vasectomized partner has received medical assessment of surgical success).

b) Male subjects with a female partner of childbearing potential must agree to use condoms for the entire Treatment Period AND for 90 days following the final dose of investigational medicinal product (IMP). Female partners are encouraged to use contraception as outlined in Inclusion 7a) from the Screening Visit until the end of the trial. Hormonal contraception that contains estrogen including ethinylestradiol is acceptable for the female partner.
Subjects who are not fertile or not sexually active, as defined below, do not require contraception.
1. Subjects who refrain from heterosexual intercourse during the trial if the reliability of the heterosexual abstinence has been evaluated in relation to the duration of the clinical trial and is the preferred and usual lifestyle of the subject.
2. Male subjects who are surgically sterile (e.g. vasectomized with medical assessment of surgical success).
3. Female subjects who are surgically sterile (e.g. status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post menopausal for at least 12 months.
Subjects must be able to swallow trial tablets whole.
Subjects assessed by the Investigator must be able to appropriately receive and store IMP, and be able to read, understand, and complete the eDiary.
Investigator believes that the subject is willing and able to adhere to all protocol requirements.
Subject provides signed informed consent and is willing and capable of complying with trial requirements and procedures.

Exclusion Criteria

Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (previously known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria.
A clinically significant history of poor response to C1-INH therapy or plasma kallikrein inhibitor therapy for the management of HAE, in the opinion of the Investigator.
Use of angiotensin converting enzyme (ACE) inhibitors after the Screening Visit or within 7 days prior to randomization.
Any estrogen containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) after the Screening Visit or within 7 days prior to randomization.
Use of narrow therapeutic index drugs metabolized by CYP3A4 or CYP2C9 or transported by OAT1, OCT2, and OATP1B1, starting at screening, as determined by the Investigator.
Use of strong CYP3A4 inhibitors and inducers during participation in the trial, starting at the Screening Visit.

Note: These medications include but are not limited to the following:

Inhibitors: boceprevir, clarithromycin, cobicistat, dasabuvir, denoprevir, elvitegravir, idelalisib, indinavir, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir ombitasvir, paritaprevir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, tipranavir, troleandomycin, and voriconazole.

Inducers: apalutamide, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John's Wort.
Inadequate organ function, including but not limited to;
1. Alanine aminotransferase (ALT) > 2x Upper limit of Normal (ULN).
2. Aspartate aminotransferase (AST) > 2x ULN.
3. Bilirubin direct > 1.25x ULN.
4. International normalized ratio (INR) > 1.2.
5. Clinically significant hepatic impairment defined as a Child-Pugh B or C.
6. Estimated glomerular filtration rate (eGFR) <60 mL/min.
Any clinically significant comorbidity or systemic dysfunction that in the opinion of the Investigator would jeopardize the safety of the subject by participating in the trial.
History of substance abuse or dependence that would interfere with the completion of the trial, as determined by the Investigator.
Known hypersensitivity to KVD824 or placebo or to any of the excipients.
Any prior use of any gene therapy treatment for HAE.
Participation in any interventional investigational clinical trial, including an investigational COVID-19 vaccine trial, within 4 weeks of the last dosing of investigational drug prior to screening.
Any pregnant or breastfeeding subject.

Name	Affiliation	Role
Study Director	KalVista Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
KalVista Investigative Site		Birmingham	Alabama	35294	United States
KalVista Investigative Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	300 mg KVD824 BID	One 300 mg KVD824 twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
FG001	600 mg KVD824 BID	Two 300 mg KVD824 tablets twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 31, 2022	Aug 15, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Rate of Investigator-confirmed HAE Attacks During the Treatment Period

To examine the number of investigator-confirmed attacks whilst on treatment compared to placebo.

Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.

Negative binomial regression on investigator-confirmed HAE attacks while on treatment (FAS) were evaluated.

The primary efficacy results should be interpreted with caution acknowledging that an insufficient number of subjects were randomized and were on study for too short a period to achieve adequate power to detect treatment effects between KVD824 and placebo groups.

Posted

Mean

95% Confidence Interval

HAE attacks

12 weeks

ID	Title	Description
OG000	300 mg KVD824 BID	One 300 mg KVD824 twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG001	600 mg KVD824 BID	Two 300 mg KVD824 tablets twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG002	900 mg KVD824 BID	Three 300 mg KVD824 tablets twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG003	Placebo to KVD824 BID	One, two or three placebo tablets to be taken twice a day for 12 weeks Placebo to KVD824: Placebo to KVD824 300 mg Modified-Release Tablets

Units	Counts
Participants	OG0007 OG0018 OG0027 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001.476(0.786 to 2.774) OG0011.072(0.534 to 2.152) OG0021.566(0.814 to 3.012) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003		Negative binomial regression model		0.2862	These results should be interpreted with caution acknowledging that an insufficient number of subjects were randomized and were on study for too short a period to achieve adequate power to detect treatment effects between KVD824 and placebo groups.	HAE rate ratio (Active vs. Placebo)	0.62			2-Sided	95	0.258	1.492			These results should be interpreted with caution acknowledging that an insufficient number of subjects were randomized and were on study for too short a period to achieve adequate power to detect treatment effects between KVD824 and placebo groups.

Secondary

Proportion of Subjects Without Investigator-confirmed HAE Attacks During the Treatment Period.

Logistic regression on subjects were measured without investigator-confirmed HAE Attacks (FAS).

Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.

Logistic regression on subjects were measured without investigator-confirmed HAE Attacks (FAS).

Posted

Count of Participants

Participants

12 weeks

ID	Title	Description
OG000	300 mg KVD824 BID	One 300 mg KVD824 twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG001	600 mg KVD824 BID	Two 300 mg KVD824 tablets twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG002	900 mg KVD824 BID	Three 300 mg KVD824 tablets twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG003	Placebo to KVD824 BID	One, two or three placebo tablets to be taken twice a day for 12 weeks Placebo to KVD824: Placebo to KVD824 300 mg Modified-Release Tablets

Secondary

Rate of Investigator-confirmed HAE Attacks That Require Conventional Treatment During the Treatment Period.

A summary of negative binomial regression on investigator-confirmed HAE attacks with conventional treatment is presented for the FAS.

Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.

Posted

Least Squares Mean

95% Confidence Interval

Est. treated attack rate over 4 weeks

12 weeks

ID	Title	Description
OG000	300 mg KVD824 BID	One 300 mg KVD824 twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG001	600 mg KVD824 BID	Two 300 mg KVD824 tablets twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG002	900 mg KVD824 BID	Three 300 mg KVD824 tablets twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG003	Placebo to KVD824 BID	One, two or three placebo tablets to be taken twice a day for 12 weeks Placebo to KVD824: Placebo to KVD824 300 mg Modified-Release Tablets

Secondary

Angioedema Quality of Life Questionnaire (AE-QoL) Total Score During the Treatment Period (Change From Baseline)

AE-QoL is a quality of life questionnaire with a range of 0 (minimum) to 100 (maximum). A total score of 100 indicates worst possible impairment.

Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.

Angioedema Quality of Life (AE-QoL) Total Score scores was measured during treatment period.

Posted

Mean

Standard Deviation

Scores on a Scale 0-100

12 weeks

ID	Title	Description
OG000	300 mg KVD824 BID	One 300 mg KVD824 twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG001	600 mg KVD824 BID	Two 300 mg KVD824 tablets twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG002	900 mg KVD824 BID	Three 300 mg KVD824 tablets twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG003	Placebo to KVD824 BID

Secondary

Angioedema Control Test (AECT) Score During the Treatment Period (Change From Baseline).

AECT is a 4-item patient-reported outcome measure. The total score is from 0 (minimum) to 16 (maximum). A higher score indicates a higher level of angioedema control.

Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.

A summary of observed values and change from baseline in AECT total score was measured for the FAS.

The higher AECT scores indicate a higher level of angioedema control.

Posted

Mean

Standard Deviation

Scores on a Scale 0-16

12 weeks

ID	Title	Description
OG000	300 mg KVD824 BID	One 300 mg KVD824 twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG001	600 mg KVD824 BID	Two 300 mg KVD824 tablets twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG002	900 mg KVD824 BID	Three 300 mg KVD824 tablets twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG003	Placebo to KVD824 BID

Secondary

Proportion of Subjects With an AECT Score ≥12 at the End of the Treatment Period.

AECT is a 4-item patient-reported outcome measure. The total score is from 0 (minimum) to 16 (maximum). A higher score indicates a higher level of angioedema control.

Given the early termination of the trial, there is insufficient enrollment to satisfy powering requirements.

Summary of Logistic Regression on proportion of subjects with AECT Score ≥12 was measured at the End of the Treatment Period (FAS).

Posted

Count of Participants

Participants

12 weeks

ID	Title	Description
OG000	300 mg KVD824 BID	One 300 mg KVD824 twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG001	600 mg KVD824 BID	Two 300 mg KVD824 tablets twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG002	900 mg KVD824 BID	Three 300 mg KVD824 tablets twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
OG003	Placebo to KVD824 BID

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0010 events0 affected8 at risk EG0021 events1 affected7 at risk EG0030 events0 affected7 at risk
Asthenia	General disorders	MedDRA 25.1	Systematic Assessment	General disorders and administration site conditions	EG0001 events1 affected7 at risk EG0010 events0 affected8 at risk EG0020 events0 affected7 at risk EG003
Fatigue	General disorders	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0011 events1 affected8 at risk EG0020 events0 affected7 at risk EG003
Menstruation irregular	Reproductive system and breast disorders	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0010 events0 affected8 at risk EG0021 events1 affected7 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment		EG0001 events1 affected7 at risk EG0010 events0 affected8 at risk EG0020 events0 affected7 at risk EG003
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 25.1	Systematic Assessment		EG0001 events1 affected7 at risk EG0010 events0 affected8 at risk EG0020 events0 affected7 at risk EG003
Mixed anxiety and depressive disorder	Psychiatric disorders	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0010 events0 affected8 at risk EG0020 events0 affected7 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 25.1	Systematic Assessment		EG0001 events1 affected7 at risk EG0011 events1 affected8 at risk EG0021 events1 affected7 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0010 events0 affected8 at risk EG0021 events1 affected7 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0010 events0 affected8 at risk EG0021 events1 affected7 at risk EG003
Liver function test abnormal	Investigations	MedDRA 25.1	Systematic Assessment		EG0001 events1 affected7 at risk EG0010 events0 affected8 at risk EG0020 events0 affected7 at risk EG003
Liver function test increased	Investigations	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0010 events0 affected8 at risk EG0021 events1 affected7 at risk EG003
Weight decreased	Investigations	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0011 events1 affected8 at risk EG0020 events0 affected7 at risk EG003
Weight increased	Investigations	MedDRA 25.1	Systematic Assessment		EG0001 events1 affected7 at risk EG0010 events0 affected8 at risk EG0020 events0 affected7 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0011 events1 affected8 at risk EG0020 events0 affected7 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0011 events1 affected8 at risk EG0020 events0 affected7 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0011 events1 affected8 at risk EG0020 events0 affected7 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0011 events1 affected8 at risk EG0020 events0 affected7 at risk EG003
Headache	Nervous system disorders	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0012 events2 affected8 at risk EG0020 events0 affected7 at risk EG003
Vision blurred	Eye disorders	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0010 events0 affected8 at risk EG0021 events1 affected7 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0011 events1 affected8 at risk EG0021 events1 affected7 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0011 events1 affected8 at risk EG0021 events1 affected7 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0011 events1 affected8 at risk EG0020 events0 affected7 at risk EG003
Hepatic cytolysis	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0011 events1 affected8 at risk EG0020 events0 affected7 at risk EG003
Hepatitis acute	Hepatobiliary disorders	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0010 events0 affected8 at risk EG0021 events1 affected7 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0010 events0 affected8 at risk EG0021 events1 affected7 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment		EG0001 events1 affected7 at risk EG0010 events0 affected8 at risk EG0020 events0 affected7 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment		EG0001 events1 affected7 at risk EG0010 events0 affected8 at risk EG0020 events0 affected7 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0011 events1 affected8 at risk EG0020 events0 affected7 at risk EG003
Skin odour abnormal	Skin and subcutaneous tissue disorders	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0011 events1 affected8 at risk EG0020 events0 affected7 at risk EG003
Urine odour abnormal	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0011 events1 affected8 at risk EG0020 events0 affected7 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0011 events1 affected8 at risk EG0020 events0 affected7 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment		EG0001 events1 affected7 at risk EG0010 events0 affected8 at risk EG0020 events0 affected7 at risk EG003
COVID-19	Infections and infestations	MedDRA 25.1	Systematic Assessment		EG0001 events1 affected7 at risk EG0012 events2 affected8 at risk EG0021 events1 affected7 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 25.1	Systematic Assessment		EG0001 events1 affected7 at risk EG0010 events0 affected8 at risk EG0020 events0 affected7 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 25.1	Systematic Assessment		EG0001 events1 affected7 at risk EG0010 events0 affected8 at risk EG0020 events0 affected7 at risk EG003
Pulpitis dental	Infections and infestations	MedDRA 25.1	Systematic Assessment		EG0001 events1 affected7 at risk EG0010 events0 affected8 at risk EG0020 events0 affected7 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 25.1	Systematic Assessment		EG0001 events1 affected7 at risk EG0010 events0 affected8 at risk EG0020 events0 affected7 at risk EG003
Viral infection	Infections and infestations	MedDRA 25.1	Systematic Assessment		EG0001 events1 affected7 at risk EG0010 events0 affected8 at risk EG0020 events0 affected7 at risk EG003
Viral upper respiratory track infection	Infections and infestations	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0011 events1 affected8 at risk EG0020 events0 affected7 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected7 at risk EG0011 events1 affected8 at risk EG0020 events0 affected7 at risk EG003

ID	Term
D054179	Angioedemas, Hereditary
D000799	Angioedema
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D014581	Urticaria
D017445	Skin Diseases, Vascular
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Title	Description
BG000	300 mg KVD824	300 mg KVD824 twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
BG001	600 mg KVD824	Two 300 mg KVD824 tablets twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
BG002	900 mg KVD824	Three 300 mg KVD824 tablets twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets
BG003	Placebo to KVD824	One, two or three placebo tablets to be taken twice a day for 12 weeks Placebo to KVD824: Placebo to KVD824 300 mg Modified-Release Tablets
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	300 mg KVD824 BID	One 300 mg KVD824 twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets	7	1	7	5	7
EG001	600 mg KVD824 BID	Two 300 mg KVD824 tablets twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets	8	1	8	6	8
EG002	900 mg KVD824 BID	Three 300 mg KVD824 tablets twice a day for 12 weeks KVD824: KVD824 300 mg Modified-Release Tablets	7	2	7	6	7
EG003	Placebo to KVD824 BID	One, two or three placebo tablets to be taken twice a day for 12 weeks Placebo to KVD824: Placebo to KVD824 300 mg Modified-Release Tablets	7	0	7	1	7