Peanut AllergyPhase 1NCT05250856
CNP-201 in Subjects With Peanut Allergy
A Phase 1 study testing CNP-201 in people with Peanut Allergy, run by COUR Pharmaceutical Development Company, Inc. at 17 sites in United States.
Trial summary
This study is a Phase 1b/2a clinical trial to assess the safety, tolerability, and pharmacodynamics of multiple ascending doses (Escalation Phase) of CNP-201 with the goal of identifying a safe and tolerable dose level to be evaluated further in a larger number of subjects (Expansion Phase). Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- CNP-201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 17 sitesUnited States
- Study dates
- 14 Mar 2022to 12 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Men and non-pregnant women, ages 16 to 55 years inclusive.
- Subjects with physician-diagnosed peanut allergy or documented history of peanut allergy. Note: If subject does not have documented history in their medical record but is reasonably suspected of having peanut allergy and is deemed to otherwise be a good candidate for this trial, the screen testing (peanut specific IgE, SPT, etc.) may be used to establish the peanut allergy and the PI may subsequently document the peanut allergy to fulfill this inclusion criterion.
- Subjects with weight ≥ 31.25 kg at Screening. Subjects who fall outside of this range may be included at the discretion of the investigator.
- Subjects with a documented history of non-severe anaphylaxis (Grade ≤ 3) to peanuts, including mild wheezing or dyspnea without hypoxia.
- Subjects with peanut specific IgE > 5 kU/L as measured by ImmunoCAP at Screening. Subjects who have previously been on OIT for peanut allergy and who do not have peanut specific IgE ≥ 5 kU/L as measured by ImmunoCAP at Screening may be included at the discretion of the investigator, OR Subjects with a positive skin prick test (SPT) to peanut with a change in wheal diameter ≥ 3 mm as compared to a negative control (50% glycerin) at Screening. Subjects who have previously been on OIT for peanut allergy and who do not have a positive skin prick test (SPT) to peanut with a change in wheal diameter ≥ 3 mm at Screening may be included at the discretion of the investigator.
- Subjects who are self-reported to be on a peanut free diet with no suspected peanut exposure, including any peanut food challenge, for at least 14 days prior to Screening and agreement to continue restriction to peanut exposure during the study.
Show all 12Show fewer
- Female subjects and male subjects and their female spouse/partners who are willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods, intrauterine device (IUD), or use of spermicide combined with a barrier method (e.g., condom, diaphragm) starting at Screening and continuing to Day 60.
- Female subjects who agree to not breastfeed starting at initial Screening and continuing to Day 60.
- Female subjects who agree to not donate ova starting at initial Screening and continuing to Day 60.
- Subjects who are willing and able to provide Institutional Review Board (IRB) approved written informed consent.
- Subjects who are willing to perform and comply with all study procedures.
- Male subjects who agree to not donate sperm starting at Screening and continuing to Day 60.
Who cannot join
- Subjects with history of severe anaphylaxis to peanuts defined as neurological compromise or requiring intubation.
- Subjects with peanut specific IgE ≥ 100 kU/L as measured by ImmunoCAP at Screening.
- Subjects who have received administration of vaccinations in the following timeframe:
- Any live vaccine (other than intranasal Influenza) within 28 days prior to Screening.
- Any subunit vaccine within 14 days prior to Screening.
- Any COVID-19 vaccine within 14 days prior to Screening. Subjects who have received the first dose of any COVID-19 vaccine may not screen for the study until 14 days following their last dose of the vaccine if applicable.
Show all 31Show fewer
- Any planned vaccination prior to Day 15.
- Subjects in build-up phase of immunotherapy for aeroallergens or venom. Individuals tolerating maintenance aeroallergen or venom immunotherapy at Screening can be enrolled.
- Subjects with relative contraindication or inability to use epinephrine auto-injector.
- Subjects who have used the following drug(s) within 2 months prior to Screening: Th2 cytokine inhibitors, thromboxane A2 synthesis inhibitors, thromboxane A2 receptor antagonists, β-blockers, angiotensin-converting enzyme inhibitors, and/or angiotensin-receptor blockers unless, in the investigator's opinion, the underlying condition being treated by the drug is well controlled and the drug dose and frequency is not expected to interfere with the mechanism of action of CNP-201 as determined in consultation with the sponsor.
- Subjects who have used biologics and/or immune modulators (including but not limited to anti-TNFα antibody and anti-IgE monoclonal antibody) within three months prior to Screening.
- Subjects with a history of allergic reactions such as anaphylactic shock, angioedema with airway constriction, or hypotension caused by food other than peanut and/or medical products.
- Subjects with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/ antibody as determined at Screening.
- Subjects who are immunocompromised, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternate days for 2 weeks or more within 6 months prior to Screening, any dose of corticosteroids within 30 days of Screening, or high dose inhaled corticosteroids [> 960 μg/day of beclomethasone dipropionate or equivalent]) or other immunosuppressive agents.
- Subjects with a history of unstable angina pectoris, cardiac disease or dysrhythmias, severe chronic lung disease, or any other chronic medical condition that which in the opinion of the investigator, would pose a significant health threat in the event of anaphylaxis/treatment of anaphylaxis.
- Subjects with active eosinophilic esophagitis (EoE) or other eosinophilic gastrointestinal disease.
- Subjects with clinically significant abnormality on electrocardiogram (ECG) at Screening that, in the investigator's opinion, makes the subject unsuitable for study participation.
- Subjects with active malignancy, or history of malignancy or chemotherapy within the past 5 years other than history of localized or surgical removal of focal skin cancer, or cervical cancer in situ treated successfully in the past by local treatment (including but not limited to cryotherapy or laser therapy) or by hysterectomy.
- Subjects with a mental condition such as schizophrenia, bipolar disorder, major depressive disorder, generalized anxiety disorder, panic disorder/attacks, or subjects who have received drug(s) for the treatment of dementia.
- Subjects with severe or poorly controlled (resistant to appropriate medical intervention) atopic disease including atopic dermatitis, generalized eczema, allergic rhinitis and/or urticaria.
- Subjects with tryptase values outside of the normal reference range.
- Subjects with severe or uncontrolled/difficult to control asthma/wheezing, defined by at least one of the following criteria:
- Global Initiative for Asthma (GINA) 2020: Personalized management to control symptoms and minimize future risk requiring treatment Steps 4 or 5 (Appendix 3) OR;
- Forced expiratory volume in 1 second (FEV1) < 80% of predicted, or ratio of FEV1 to forced vital capacity (FEV1/FVC) < 75% of predicted, with or without controller medications (only those able to reliable perform spirometry. If unable to do spirometry, PEF of > 80% is acceptable OR;
- One overnight admission to a hospital in the past year for asthma OR;
- Emergency room visit for asthma within 6 months prior to Screening OR;
- History of two or more systemic corticosteroid courses within 6 months of Screening or one course of systemic corticosteroids within 3 months of Screening to treat asthma/wheezing OR;
- Prior intubation/mechanical ventilation for asthma/wheezing.
- Subjects who have received an investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to Screening.
- Subjects with any condition which, in the investigator's opinion, makes the subject unsuitable for study participation: Past or current medical problems, history of other chronic diseases requiring therapy, findings from physical assessment, or abnormalities in clinical laboratory testing that are not listed above, which in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.
- Subjects with a known sensitivity to any components of CNP-201 (PLGA, sucrose, mannitol, or sodium citrate).
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
AllerVie Clinical Research
Birmingham, Alabama, 35209
Institute for Asthma & Allergy
Chevy Chase, Maryland, 20815
Rush University Medical Center
Chicago, Illinois, 60612
Aventiv Research, Inc
Columbus, Ohio, 43213
Allergy Partners of North Texas Research
Dallas, Texas, 75230
Pharmaceutical Research & Consulting, Inc
Dallas, Texas, 75231
Western Sky Medical Research
El Paso, Texas, 79903
Tranquil Clinical and Research Consulting Services
Houston, Texas, 77598
Long Beach Clinical Trials, LLC
Long Beach, California, 90806
Southern California Research
Mission Viejo, California, 92691
Sneeze, Wheeze and Itch Associates, LLC
Normal, Illinois, 61761
National Allergy and Asthma Research, LLC
North Charleston, South Carolina, 29420
Meridian Clinical Research. LLC
Overland Park, Kansas, 66210
Clinical Research Partners
Richmond, Virginia, 23226
Allergy & Asthma Medicaal Group and Research Center
San Diego, California, 60062
Seattle Allergy & Asthma Research Institute
Seattle, Washington, 98115
Vital Prospects Clinica Research Institute
Tulsa, Oklahoma, 74136
About this study
Official title: A Phase 1b/2a Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of CNP-201 in Subjects Ages 16-55 With Peanut Allergy
This study is a Phase 1b/2a clinical trial to assess the safety, tolerability, and pharmacodynamics of multiple ascending doses (Escalation Phase) of CNP-201 with the goal of identifying a safe and tolerable dose level to be evaluated further in a larger number of subjects (Expansion Phase).
Read the detailed description
The Escalation Phase will consist of multiple cohorts (4 subjects per cohort) to identify a safe and tolerable dose(s). The Expansion Phase will consist of up to 40 additional subjects who will receive either a Placebo or CNP-201 at a safe and tolerable dose as determined from the Escalation Phase. One or more dose levels may be explored in the Expansion Phase.
Subjects who meet all inclusion and no exclusion criteria at screening will be enrolled into the study.
In the Escalation Phase, each cohort of four (4) subjects will receive CNP-201 by intravenous (IV) infusion on Days #1 and #8. Subjects in the Expansion Phase will be randomized in a 1:1 ratio to receive either a safe and tolerable dose level of CNP-201 identified in the Escalation Phase or Placebo (0.9% Sodium Chloride for injection).
Subjects will remain in the clinic on Days #1 and #8 from the time of admission (prior to administration of CNP-201 or Placebo) through the final procedure conducted 4-hours post-dose that same day unless an infusion reaction, anaphylaxis, or other adverse event requires an extended duration of monitoring. Subjects will be discharged if safety parameters are acceptable to the investigator. Seven (7) days after the second administration of CNP-201 or Placebo, subjects must return to the clinic for collection of safety labs, PD measurements, and assessment of AEs and medication changes.
Subjects will continue to be followed for safety, and tolerability during a 52-day Post-Dosing period.
On Day 60, subjects will return to the clinic for collection of immune safety labs, PD measurements and to undergo Day 1 a Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) consisting of peanut and placebo (oat) challenges. On Day 61, subjects will return to the clinic to undergo Day 2 of the DBPCFC and final assessment of AEs and medication changes.
The total duration of the study for an individual subject is approximately 67 days: 7 days for Screening; 8 days for CNP-201 or Placebo dosing; and 52 days post-dosing evaluation.
- Conditions
- Peanut Allergy
- Being tested
- CNP-201, Placebo
- Keywords
- Allergy, Food Allergy
- Medical subject headings
- Peanut Hypersensitivity, Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNP-201Drug
CNP-201 is comprised of purified peanut extract (PPE) drug substance dispersed within a negatively charged polymer matrix of poly (lactic-co-glycolic acid) (PLGA) particles at a target concentration of ~5 μg of PPE per mg of PLGA.
PlaceboDrug
Placebo, (0.9% Sodium Chloride for IV infusion)
| Study group | Role | What they receive |
|---|---|---|
| CNP-201 1 mg | Experimental | intravenous infusion on Day 1 and Day 8: 1 mg CNP-201 Receives: Drug: CNP-201 |
| CNP-201 2 mg | Experimental | intravenous infusion on Day 1 and Day 8: 2 mg CNP-201 Receives: Drug: CNP-201 |
| CNP-201 4 mg | Experimental | intravenous infusion on Day 1 and Day 8: 4 mg CNP-201 Receives: Drug: CNP-201 |
| CNP-201 8 mg | Experimental | intravenous infusion on Day 1 and Day 8: 8 mg CNP-201 Receives: Drug: CNP-201 |
| Placebo | Placebo comparator | 200 ml intravenous infusion on Day 1 and Day 8: CNP-201 Placebo Receives: Drug: CNP-201; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Frequency tables will be presented by treatment group for all AEs and SAEs by System Organ Class (SOC) and Preferred Term (PT). Frequency tables will also be produced by treatment group for AEs leading to discontinuation from TP and study, by severity, and by causality. No formal statistical testing will be done.
Measured: through Study Completion, an average of 67 Days
Serum Cytokines (TNF-α, IL-2, IL-6, IL-8, IL-1β, MCP-1, MIP-1β, MIP-1α, IFN-γ, and IL-12p70)
Summary statistics will be presented for the change from baseline values for Serum Cytokines (TNF-α, IL-2, IL-6, IL-8, IL-1β, MCP-1, MIP-1β, MIP-1α, IFN-γ, and IL-12p70)
Measured: Baseline (Day 1 pre-dose) through Day 60, an average of 52 Days
Secondary outcomes (6)
Change in the ratio of peanut specific IgE to IgG
The mean change in the ratio of peanut specific IgE to IgG as measured by ImmunoCap assay from Baseline (Screening) to Visit 5 within CNP-201 and Placebo treatment groups will be analyzed
Measured: Baseline (Day 1 pre-dose) through Day 60, an average of 52 Days
Change in peanut specific IgE between CNP-201 and Placebo
The mean change of peanut specific IgE to IgG as measured by ImmunoCap assay from Baseline (Screening) to Visit 5 within CNP-201 and Placebo treatment groups will be analyzed
Measured: Baseline (Day 1 pre-dose) through Day 60, an average of 52 Days
Difference in percentage of subjects who pass a DBPCFC
Difference in percentage of subjects who pass a DBPCFC (do not reach an eliciting dose at or before the 2000 mg dose level, 4043 mg cumulative) between placebo and CNP-201 at Day 60 and at Day 180
Measured: At Day 60
Change in the proportion of peanut specific Th2a+ T cells
Change in the proportion of peanut specific Th2a+ T cells (peanut specific Th2a+ cells / total peanut specific T cells) following ex vivo stimulation of PBMCs between placebo and CNP-201 at baseline and at Day 15
Measured: Baseline (Day 1 pre-dose) through Day 15, an average of 15 Days
Change in the effective concentration at 50% of maximal basophil activation (EC50)
Change in the effective concentration at 50% of maximal basophil activation (EC50) as measured by a Basophil Activation Test (CD203c+/CD63+/- basophil activation) between placebo and CNP-201 at baseline and at Day 60 and at Day 180
Measured: Baseline (Day 1 pre-dose), at Day 15, and at Day 60
Change in the proportion of peanut specific T regulatory cells (peanut specific T regulatory cells / peanut specific CD4+ effector memory cells)
Change in the proportion of peanut specific T regulatory cells (peanut specific T regulatory cells / peanut specific CD4+ effector memory cells) following ex vivo stimulation of PBMCs between placebo and CNP 201 at baseline and at Day 15
Measured: Baseline (Day 1 pre-dose) and at Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start14 Mar 2022
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Why it stopped: Lagging Enrollment and Administrative Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study was designed with multiple ascending doses of CNP-201 in a Dose Escalation Phase, with the goal of identifying a safe and tolerable dose level to be evaluated further in a larger number of subjects in a Dose Expansion Phase. However, the study was terminated for administrative reasons and lagging enrollment within the Dose Escalation Phase.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- COUR Pharmaceutical Development Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerry Staser, Study director, COUR Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250856
- Sponsor's protocol ID
- CNP-201-5.002
- Status last verified
- Dec 2023
- First submitted
- 11 Feb 2022
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of CNP-201 in Subjects Ages 16-55 With Peanut Allergy
- ClinicalTrials.gov ID
- NCT05250856
- Acronym / sponsor ID
- CNP-201-5.002
- Conditions
- Peanut Allergy
- Keywords
- Allergy, Food Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lagging Enrollment and Administrative Reasons
- Enrolment
- 15 participants (actual)
- Lead sponsor
- COUR Pharmaceutical Development Company, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase 1b/2a clinical trial to assess the safety, tolerability, and pharmacodynamics of multiple ascending doses (Escalation Phase) of CNP-201 with the goal of identifying a safe and tolerable dose level to be evaluated further in a larger number of subjects (Expansion Phase).
Detailed description
The Escalation Phase will consist of multiple cohorts (4 subjects per cohort) to identify a safe and tolerable dose(s). The Expansion Phase will consist of up to 40 additional subjects who will receive either a Placebo or CNP-201 at a safe and tolerable dose as determined from the Escalation Phase. One or more dose levels may be explored in the Expansion Phase.
Subjects who meet all inclusion and no exclusion criteria at screening will be enrolled into the study.
In the Escalation Phase, each cohort of four (4) subjects will receive CNP-201 by intravenous (IV) infusion on Days #1 and #8. Subjects in the Expansion Phase will be randomized in a 1:1 ratio to receive either a safe and tolerable dose level of CNP-201 identified in the Escalation Phase or Placebo (0.9% Sodium Chloride for injection).
Subjects will remain in the clinic on Days #1 and #8 from the time of admission (prior to administration of CNP-201 or Placebo) through the final procedure conducted 4-hours post-dose that same day unless an infusion reaction, anaphylaxis, or other adverse event requires an extended duration of monitoring. Subjects will be discharged if safety parameters are acceptable to the investigator. Seven (7) days after the second administration of CNP-201 or Placebo, subjects must return to the clinic for collection of safety labs, PD measurements, and assessment of AEs and medication changes.
Subjects will continue to be followed for safety, and tolerability during a 52-day Post-Dosing period.
On Day 60, subjects will return to the clinic for collection of immune safety labs, PD measurements and to undergo Day 1 a Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) consisting of peanut and placebo (oat) challenges. On Day 61, subjects will return to the clinic to undergo Day 2 of the DBPCFC and final assessment of AEs and medication changes.
The total duration of the study for an individual subject is approximately 67 days: 7 days for Screening; 8 days for CNP-201 or Placebo dosing; and 52 days post-dosing evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- The study was designed with multiple ascending doses of CNP-201 in a Dose Escalation Phase, with the goal of identifying a safe and tolerable dose level to be evaluated further in a larger number of subjects in a Dose Expansion Phase. However, the study was terminated for administrative reasons and lagging enrollment within the Dose Escalation Phase.
| Arm | Type | Receives |
|---|---|---|
| CNP-201 1 mg | Experimental | Drug: CNP-201intravenous infusion on Day 1 and Day 8: 1 mg CNP-201 |
| CNP-201 2 mg | Experimental | Drug: CNP-201intravenous infusion on Day 1 and Day 8: 2 mg CNP-201 |
| CNP-201 4 mg | Experimental | Drug: CNP-201intravenous infusion on Day 1 and Day 8: 4 mg CNP-201 |
| CNP-201 8 mg | Experimental | Drug: CNP-201intravenous infusion on Day 1 and Day 8: 8 mg CNP-201 |
| Placebo | Placebo comparator | Drug: CNP-201, Drug: Placebo200 ml intravenous infusion on Day 1 and Day 8: CNP-201 Placebo |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Men and non-pregnant women, ages 16 to 55 years inclusive.
- Subjects with physician-diagnosed peanut allergy or documented history of peanut allergy. Note: If subject does not have documented history in their medical record but is reasonably suspected of having peanut allergy and is deemed to otherwise be a good candidate for this trial, the screen testing (peanut specific IgE, SPT, etc.) may be used to establish the peanut allergy and the PI may subsequently document the peanut allergy to fulfill this inclusion criterion.
- Subjects with weight ≥ 31.25 kg at Screening. Subjects who fall outside of this range may be included at the discretion of the investigator.
- Subjects with a documented history of non-severe anaphylaxis (Grade ≤ 3) to peanuts, including mild wheezing or dyspnea without hypoxia.
- Subjects with peanut specific IgE > 5 kU/L as measured by ImmunoCAP at Screening. Subjects who have previously been on OIT for peanut allergy and who do not have peanut specific IgE ≥ 5 kU/L as measured by ImmunoCAP at Screening may be included at the discretion of the investigator, OR Subjects with a positive skin prick test (SPT) to peanut with a change in wheal diameter ≥ 3 mm as compared to a negative control (50% glycerin) at Screening. Subjects who have previously been on OIT for peanut allergy and who do not have a positive skin prick test (SPT) to peanut with a change in wheal diameter ≥ 3 mm at Screening may be included at the discretion of the investigator.
Key exclusion criteria (31 listed)
- Subjects with history of severe anaphylaxis to peanuts defined as neurological compromise or requiring intubation.
- Subjects with peanut specific IgE ≥ 100 kU/L as measured by ImmunoCAP at Screening.
- Subjects who have received administration of vaccinations in the following timeframe:
- Any COVID-19 vaccine within 14 days prior to Screening. Subjects who have received the first dose of any COVID-19 vaccine may not screen for the study until 14 days following their last dose of the vaccine if applicable.
- Any planned vaccination prior to Day 15.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CNP-201CNP-201 is comprised of purified peanut extract (PPE) drug substance dispersed within a negatively charged polymer matrix of poly (lactic-co-glycolic acid) (PLGA) particles at a target concentration of ~5 μg of PPE per mg of PLGA. | Drug | CNP-201 1 mg, CNP-201 2 mg, CNP-201 4 mg, CNP-201 8 mg, Placebo |
| PlaceboPlacebo, (0.9% Sodium Chloride for IV infusion) | Drug | Placebo |
Primary outcome
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: through Study Completion, an average of 67 Days
Frequency tables will be presented by treatment group for all AEs and SAEs by System Organ Class (SOC) and Preferred Term (PT). Frequency tables will also be produced by treatment group for AEs leading to discontinuation from TP and study, by severity, and by causality. No formal statistical testing will be done.
Serum Cytokines (TNF-α, IL-2, IL-6, IL-8, IL-1β, MCP-1, MIP-1β, MIP-1α, IFN-γ, and IL-12p70)
Time frame: Baseline (Day 1 pre-dose) through Day 60, an average of 52 Days
Summary statistics will be presented for the change from baseline values for Serum Cytokines (TNF-α, IL-2, IL-6, IL-8, IL-1β, MCP-1, MIP-1β, MIP-1α, IFN-γ, and IL-12p70)
6 secondary outcomes
Change in the ratio of peanut specific IgE to IgG
Time frame: Baseline (Day 1 pre-dose) through Day 60, an average of 52 Days
Change in peanut specific IgE between CNP-201 and Placebo
Time frame: Baseline (Day 1 pre-dose) through Day 60, an average of 52 Days
Difference in percentage of subjects who pass a DBPCFC
Time frame: At Day 60
Change in the proportion of peanut specific Th2a+ T cells
Time frame: Baseline (Day 1 pre-dose) through Day 15, an average of 15 Days
Change in the effective concentration at 50% of maximal basophil activation (EC50)
Time frame: Baseline (Day 1 pre-dose), at Day 15, and at Day 60
Change in the proportion of peanut specific T regulatory cells (peanut specific T regulatory cells / peanut specific CD4+ effector memory cells)
Time frame: Baseline (Day 1 pre-dose) and at Day 15
Results and safety
The study was stopped early (reason given: Lagging Enrollment and Administrative Reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Peanut Allergy
Active, not recruitingPhase 2
A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
Peanut Allergy, Peanut Hypersensitivity
Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
RecruitingPhase 2
Efficacy of Tezepelumab in Peanut Oral Immunotherapy
Peanut Allergy
Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry Staser study director
COUR Pharmaceuticals
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CNP-201 in people with Peanut Allergy, run by COUR Pharmaceutical Development Company, Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lagging Enrollment and Administrative Reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: through Study Completion, an average of 67 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.