A Study of NN2802, an Anti-c-Kit Antibody, in Healthy Participants and in Adults With Chronic Spontaneous Urticaria (CSU)
NCT07930572, Phase 1, Phase 2, Recruiting, Novelty Nobility, Inc.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study of NN2802, an Anti-c-Kit Antibody, in Healthy Participants and in Adults With Chronic Spontaneous Urticaria (CSU) | ClinicalTrials.gov |
| NCT number | NCT07930572 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 46 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Novelty Nobility, Inc. | ClinicalTrials.gov |
| Conditions | Healhty, Chronic Spontaneous Urticaria (CSU) | ClinicalTrials.gov |
| Interventions | NN2802 | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Part A: Incidence of Adverse Events | 14 weeks | Safety parameters \[adverse events (AEs), physical examinations, vital signs, electrocardiograms (ECG findings), and laboratory values. | ClinicalTrials.gov |
| Primary | Part B: Incidence of Adverse Events | 22 weeks | Safety parameters \[adverse events (AEs), physical examinations, vital signs, electrocardiograms (ECG findings), and laboratory values. | ClinicalTrials.gov |
| Secondary | Part A: Pharmacokinetics (PK) of NN2802 | 14 weeks | PK parameters by measureing serum concentration of NN2802 | ClinicalTrials.gov |
| Secondary | Part A: Pharmacodynamics(PD) of NN2802 | 14 weeks | Change in biomarkers such as serum tryptase. | ClinicalTrials.gov |
| Secondary | Part B: Pharmacokinetics (PK)of NN2802 | 22 weeks | PK parameters by measureing serum concentration of NN2802 | ClinicalTrials.gov |
| Secondary | Part B: Pharmacodynamics(PD) of NN2802 | 22 weeks | Change in biomarkers such as serum tryptase. | ClinicalTrials.gov |
| Secondary | Part B: Change from baseline of UAS7 over time. | 22 weeks | ClinicalTrials.gov | |
| Secondary | Part B: Change from baseline of ISS7 over time. | 22 weeks | ClinicalTrials.gov | |
| Secondary | Part B: Change from baseline of HSS7 over time. | 22 weeks | ClinicalTrials.gov | |
| Secondary | Part B: Change from baseline of CU-Q2oL over time. | 22 weeks | ClinicalTrials.gov | |
| Secondary | Part B: Change from baseline of UCT over time. | 22 weeks | ClinicalTrials.gov | |
| Secondary | Part B: Proportion of participants achieving UAS7=0 over time. | 22 weeks | ClinicalTrials.gov | |
| Secondary | Part B: Cumulative number of weeks that participants achieve an AAS7 score=0 after baseline and over time. | 22 weeks | ClinicalTrials.gov | |
| Other | Part A: Immunogenicity of NN2802 | 14 weeks | Immunogenicity assessed by ADA analyses | ClinicalTrials.gov |
| Other | Part A: Additional PD biomarkers | 14 weeks | Change in biomarkers including but not limited to serum-stem cell factor (s-SCF) and skin biopsy | ClinicalTrials.gov |
| Other | Part B: Immunogenicity of NN2802 | 22 weeks | Immunogenicity assessed by ADA analyses | ClinicalTrials.gov |
| Other | Part B: Additional PD biomarkers | 22 weeks | Change in biomarkers including but not limited to s-SCF and skin biopsy. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.