Investigation of CRD007 in asthma patients

A Double-Blind, Randomised, Placebo-controlled, Parallel Group, International, Multi-centre Phase 2 Trial Investigating the Safety and Efficacy of CRD007 in Adult Subjects with Asthma - RSPR-008

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002656-26-DK

Enrollment

160

Registered

2015-09-25

Start date

2015-11-25

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 18.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: CRD007 Product Code: CRD007 Pharmaceutical Form: Tablet INN or Proposed INN: PEMIROLAST CAS Number: 69372-19-6 Current Sponsor code: CRD007 Concentration unit: mg milligram(s) Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent must be obtained before any trial related procedures are performed 2. Age =18 years old 3. Diagnosis of asthma according to GINA Guidelines (1) 4. Atopic phenotype 5. Treated with ICS and LABA for at least 12 weeks prior to Visit 1 6. Blood eosinophils =0.05*109/L at Visit 1 7. Demonstration of FEV1 at Visit 1 = 60% of the predicted value 8. Demonstration of ACQ6 = 0.5 and =2.5 at Visit 1 9. Reversibility demonstrated at Visit 1 or 2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Lower respiratory tract infection <6 weeks prior to Visit 1 2. Smokers 3. Treatment with disallowed medication 4. Pregnant and breast-feeding female subjects 5. Receipt of any experimental agents within 30 days prior to Visit 1 6. Participation in any other interventional clinical trial during the trial period 7. Significant Medical history 8. Abnormal blood levels 9. Subjects known or suspected of not being able to comply with the trial-related procedures

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficacy of 200 mg CRD007 administered orally b.i.d. on asthma control during tapering of a background therapy of standard asthma controller medication (ICS and LABA).;Secondary Objective: •Treatment failure e.g: o Subject is withdrawn o Worsening of asthma oSubject does not fulfil criteria for reduced ICS dose •Safety profile of CRD007 ;Primary end point(s): Average dose of (Inhaled corticosteroids) ICS;Timepoint(s) of evaluation of this end point: From Visit 5 to Visit 10.	—

Measure

Time frame

Main Objective: To investigate the efficacy of 200 mg CRD007 administered orally b.i.d. on asthma control during tapering of a background therapy of standard asthma controller medication (ICS and LABA).;Secondary Objective: •Treatment failure e.g: o Subject is withdrawn o Worsening of asthma oSubject does not fulfil criteria for reduced ICS dose •Safety profile of CRD007 ;Primary end point(s): Average dose of (Inhaled corticosteroids) ICS;Timepoint(s) of evaluation of this end point: From Visit 5 to Visit 10.

—

Secondary

Measure	Time frame
Secondary end point(s): •Treatment failure from randomization e.g: o Subject is withdrawn o Worsening of asthma oSubject does not fulfil criteria for reduced ICS dose •Safety profile of CRD007 ;Timepoint(s) of evaluation of this end point: From visit 3 to visit 11	—

Countries

Bulgaria, Denmark, Poland, United Kingdom

Contacts

Public ContactMimi Folden Flensburg

RSPR Pharma AB

mimi.flensburg@rsprpharma.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026