Phase 4 N=10 Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy
Idiopathic Angioedema
Primary: Mean 7-day Angioedema Activity Score (AAS7) — 2.8; 1.6; 0.69; 0.20 score on a scale
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=38 Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Hereditary Angioedema · Angioneurotic Edema
Primary: Time to Beginning of Relief of Symptoms — 68; 122; 258; 62.5 minutes — p=0.001
Phase 3 N=32 Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Hereditary Angioedema · Angioneurotic Edema · Genetic Disorders
Primary: Time to Beginning of Relief of Symptoms — 62; 508; 61 minutes — p=0.003
Phase 3 N=57 C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)
Hereditary Angioedema
Primary: Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population) — 0.46 hours
Phase 3 N=126 Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks
Hereditary Angioedema
Primary: Time to Start of Relief of Symptoms From HAE Attack — 1.17; 0.5; 1.5 Hours — p=0.0025
Phase 3 N=121 Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Primary: Time to Meeting Discharge Criteria (TMDC) — 4.03; 4.00 days — p=0.633
Phase 2 N=74 Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema
Hereditary Angioedema · Hereditary Angioedema Type I · Hereditary Angioedema Type II
Primary: Change of the 3-symptom Composite Visual Analogue Scale (VAS-3) Score From Pre-treatment to 4 Hours Post-treatment — -14.83; -13.10; -14.37; 1.92 Score on a scale — p=<…
Phase 2 N=25 A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration
Genetic Disorders · Hereditary Angioedema
Primary: HAE Attacks/Week — 0.9; 0.4 attacks/week
Phase 3 N=84 Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema
Angioedema
Primary: Time to Onset of Symptom Relief (TOSR) — 2.5; 4.6 Hours — p=0.142
Phase 2 N=68 A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II
Hereditary Angioedema
Primary: Time to Conventional Attack Treatment Use Within 12 Hours of Study Drug (Full Analysis Set) — NA; NA Time (h) — p=0.0010
Phase 4 N=19 Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE
Hereditary Angioedema
Primary: Time to Complete or Near Complete Resolution From Onset of Symptoms — 735; 377 minutes
Phase 2 N=75 Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema
Hereditary Angioedema (HAE)
Primary: Number of Confirmed HAE Attacks — 0.519; 0.527; 0.249; 0.852 HAE attacks per week — p=<0.001
Phase 3 N=387 A Long Term Safety Study of BCX7353 in Hereditary Angioedema
Hereditary Angioedema · HAE · Prophylaxis
Primary: Safety & Tolerability — 94; 240; 58; 119 Participants
Phase 3 N=73 A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor
Angioedema
Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) During…
N/A N=42 The Role of Vitamin D in Chronic Urticaria and Angioedema Treatment
Urticaria · Angioedema · Hives
Primary: Medication Usage — 2.8; 4.6; 2.0; 4.9 number of pills/day
Phase 2 N=61 Urticaria Facticia Treatment With Omalizumab (UFO)
Symptomatic Dermographism
Primary: Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo — -1.8; -2.0; -0.6 wheal…
Phase 3 N=64 CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks
Hereditary Angioedema
Primary: Time-Normalized Number of Hereditary Angioedema (HAE) Attacks Per Month During Treatment Period — 0.27; 2.01 number of HAE attacks per month — p=<0.001
Phase 4 N=18 Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU)
Urticaria Chronic
Primary: Time to 50% Decline in Clinical Symptoms Measured by the Urticaria Activity Score Seven Day(UAS7) — 23; 12 days
Phase 2 N=16 A Randomized, Double-Blind, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis
Anaphylaxis · Hypotension · Bronchospasm
Primary: Reduction in the Number and Timing of Anaphylactic Events in Subjects With a History of Frequent Idiopathic Anaphylaxis. — 32; 6 percentage of change of events
Phase 3 N=75 Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
Hereditary Angioedema (HAE)
Primary: Time-Normalized Number of Attacks (NNA) for Participants During a Treatment Period — 1.611; 3.931 Number of attacks — p=<0.0001
Phase 3 N=90 A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
Hereditary Angioedema Types I and II
Primary: The Time-normalized Number of Hereditary Angioedema Attacks — 0.04; 0.02; 0.12; 0.13 attacks/day — p=< 0.001
Phase 3 N=77 A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)
Angioedema
Primary: Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 — 1.63; 2.17 attacks/month — p==0.899
Phase 3 N=75 Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks
Hereditary Angioedema
Primary: Time to Beginning of Relief of Symptoms — 90; 152 minutes
Phase 3 N=8 Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE)
Hereditary Angioedema (HAE)
Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 7 Participants
Phase 2 N=58 Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema
Hereditary Angioedema (HAE)
Primary: Proportion of Subjects With Improved or Stable Composite Visual Analog Scale (VAS) Score — 13.96; 15.04; 10.54; 18.42 VAS score - millimeters — p=0.0024
Phase 3 N=32 A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
Hereditary Angioedema (HAE)
Primary: Time to Peak Concentration (Tmax) of a Single Subcutaneous (SC) Dose of Icatibant — 0.42; 0.55; 0.57 Hour (h)
Phase 3 N=125 Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
Hereditary Angioedema (HAE)
Primary: Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period — 1.967; 0.480; 0.526; 0.257 Attacks per 4 weeks — p=<0.001
Phase 3 N=83 C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
Hereditary Angioedema
Primary: Time to Beginning of Substantial Relief of the Defining Symptom — 2.0; 4.0 hours — p=0.048
Phase 2 N=90 A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
Chronic Idiopathic Urticaria
Primary: Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4 — -6.91; -9.79; -19.93; -14.56 scores on a scale — p=0.1601
Phase 3 N=110 A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
Hereditary Angioedema
Primary: Time to Beginning of Symptom Relief Patient Global Impression of Change (PGI-C) — 1.61; 1.79; 6.72 Time (h) — p=<0.0001