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Trials |  |
News |  |
- rademikibart (CBP-201) / Suzhou Connect Biopharma
Improved lung function and asthma control observed with rademikibart in patients with moderate-to-severe asthma (Lehar 3) - May 31, 2024 - Abstract #ERS2024ERS_2676;
P2
Full Analysis Set Baseline EOS ? 300 cells/
- ||| P2 data, P3 data, Review, Journal: Emerging drugs for the treatment of atopic dermatitis: a focus on phase 2 and phase 3 trials. (Pubmed Central) - Apr 25, 2024
Clinical trials for 36 agents currently in phase 2 or phase 3 are evaluated with particular focus on the studies for, B244, CBP-201, Tapinarof, Lebrikizumab, Nemolizumab, Amlitelimab, and Rocatinlimab as they explore novel pathways and have some of the most promising results. These clinical trials contribute to the evolution of AD treatment toward greater precision based on salient pathways with a particular focus on moderate-to-severe AD to enhance efficacy and minimize adverse effects.
- rademikibart (CBP-201) / Suzhou Connect Biopharma
Improved Lung Function and Asthma Control Observed With Rademikibart in Patients With Moderate-to-Severe Uncontrolled Asthma (CBP-201-WW002) (San Diego Convention Center, Room 31A-C (Upper Level)) - Mar 17, 2024 - Abstract #ATS2024ATS_8734;
P2
Strong and significant improvement in asthma control was also observed. Rademikibart could benefit a substantial group of uncontrolled asthmatic patients who struggle for asthma control and freedom from exacerbations.
- || rademikibart (CBP-201) / Suzhou Connect Biopharma
Clinical, P2 data, Journal: Efficacy and safety of rademikibart (CBP-201), a next-generation monoclonal antibody targeting IL-4R?, in adults with moderate-to-severe atopic dermatitis: a phase 2 randomized trial (CBP-201-WW001). (Pubmed Central) - Jan 2, 2024
Rademikibart was efficacious and well tolerated at Q2W and Q4W intervals. Q4W dosing is a more convenient frequency than approved for current therapies.
- || rademikibart (CBP-201) / Suzhou Connect Biopharma
Biomarker, Clinical, P1 data, Journal: Rademikibart (CBP-201), a next-generation monoclonal antibody targeting human IL-4R?: Two phase I randomized trials, in healthy individuals and patients with atopic dermatitis. (Pubmed Central) - Dec 17, 2023
Efficacy responses did not plateau and were generally dose dependent. These promising findings support further development of rademikibart in patients with AD.
- |||| rademikibart (CBP-201) / Suzhou Connect Biopharma
Trial completion, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of CBP-201 in Moderate to Severe Atopic Dermatitis in China (clinicaltrials.gov) - Nov 2, 2023
P2, N=330, Completed, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
These promising findings support further development of rademikibart in patients with AD. Active, not recruiting --> Completed | Trial primary completion date: Sep 2023 --> Dec 2022
- ||| rademikibart (CBP-201) / Suzhou Connect Biopharma
Trial completion: A Study to Evaluate the Pharmacokinetics Similarity of CBP-201 in Healthy Adult Chinese Subjects (clinicaltrials.gov) - Oct 31, 2023
P1, N=324, Completed, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
Active, not recruiting --> Completed | Trial primary completion date: Sep 2023 --> Dec 2022 Active, not recruiting --> Completed
- || rademikibart (CBP-201) / Suzhou Connect Biopharma
Enrollment closed: A Study to Evaluate the Pharmacokinetics Similarity of CBP-201 in Healthy Adult Chinese Subjects (clinicaltrials.gov) - Sep 6, 2023
P1, N=324, Active, not recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || rademikibart (CBP-201) / Suzhou Connect Biopharma
Trial primary completion date: A Study to Evaluate the Efficacy and Safety of CBP-201 in Moderate to Severe Atopic Dermatitis in China (clinicaltrials.gov) - Aug 14, 2023
P2, N=330, Active, not recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
Recruiting --> Active, not recruiting Trial primary completion date: Jul 2022 --> Sep 2023
- | rademikibart (CBP-201) / Suzhou Connect Biopharma
Preclinical, Journal: Preclinical immunological characterization of rademikibart (CBP-201), a next-generation human monoclonal antibody targeting IL-4R?, for the treatment of Th2 inflammatory diseases. (Pubmed Central) - Jul 31, 2023
In summary, rademikibart bound to a distinct IL-4R? epitope with high affinity and demonstrated reductions in Th2 inflammatory biomarkers with at least similar and potentially superior potency to dupilumab.
- ||| rademikibart (CBP-201) / Suzhou Connect Biopharma
Enrollment open: A Study to Evaluate the Pharmacokinetics Similarity of CBP-201 in Healthy Adult Chinese Subjects (clinicaltrials.gov) - Jul 20, 2023
P1, N=324, Recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
epitope with high affinity and demonstrated reductions in Th2 inflammatory biomarkers with at least similar and potentially superior potency to dupilumab. Not yet recruiting --> Recruiting
- |||| rademikibart (CBP-201) / Suzhou Connect Biopharma
Enrollment open: A Study to Evaluate the Safety and Efficacy of CBP-201 in Chinese Adult Subjects With Moderate to Severe AD (clinicaltrials.gov) - Jul 20, 2023
P2, N=360, Recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- rademikibart (CBP-201) / Suzhou Connect Biopharma
Improvements in patient-reported outcomes (PROs) across 16 weeks of treatment with CBP-201 for moderate-to-severe atopic dermatitis (AD): Results from a pivotal trial in China (CBP-201-CN002) () - Jul 3, 2023 - Abstract #WCD2023WCD_4961;
P2
Patients reported rapid and sustained improvements in AD, including pruritus, and better QoL across 16 weeks of treatment with CBP-201. These patient-reported improvements are compatible with investigator-assessed findings, including reductions in the primary endpoint (proportion of patients with IGA 0/1 scores and ?2-point reduction from baseline at Week 16) and a key secondary endpoint (EASI-75), and are confirmatory of data previously reported from the global phase 2 AD trial with CBP-201
- rademikibart (CBP-201) / Suzhou Connect Biopharma
Improvements in investigator-rated outcomes across 16 weeks of treatment with CBP-201 for moderate-to-severe atopic dermatitis (AD): Results from a pivotal trial in China (CBP-201-CN002) () - Jul 3, 2023 - Abstract #WCD2023WCD_4960;
P2
Investigators reported rapid and sustained improvements in AD across 16 weeks of treatment with CBP-201. These reductions in investigator-assessed AD severity are mirrored by improvements in patient-reported outcomes and are confirmatory of data previously reported from the global phase 2 AD trial with CBP-201
- rademikibart (CBP-201) / Suzhou Connect Biopharma
Eczema Area and Severity Index (EASI) scores improved, with favorable safety and tolerability, across 16 weeks of treatment with CBP-201 for moderate-to-severe atopic dermatitis (AD) in China () - Jul 3, 2023 - Abstract #WCD2023WCD_4926;
P2
CBP-201 had favorable safety and tolerability profiles. The findings are confirmatory of outcomes previously reported from the global phase 2 AD trial
- rademikibart (CBP-201) / Suzhou Connect Biopharma
CBP-201, a next-generation IL-4R? antibody, achieved all primary and key secondary endpoints in a randomized pivotal trial for moderate-to-severe atopic dermatitis (AD) in China (CBP-201-CN002) () - Jul 3, 2023 - Abstract #WCD2023WCD_4894;
P2
This pivotal trial of CBP-201 in China achieved its primary and secondary endpoints; rapid and sustained improvements were observed in AD (including pruritus), without reaching a plateau, indicating potential for further improvement beyond 16 weeks. Improvements in objective skin measurements were mirrored by patient-reported benefits on quality of life
- ||| rademikibart (CBP-201) / Suzhou Connect Biopharma
New P1 trial: A Study to Evaluate the Pharmacokinetics Similarity of CBP-201 in Healthy Adult Chinese Subjects (clinicaltrials.gov) - Jun 26, 2023
P1, N=324, Not yet recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
- CBP-201 / Suzhou Connect Biopharma
Poten ally greater efficacy with CBP-201 for adults with severe versus moderate atopic derma s at baseline: subgroup analyses from the WW001 phase 2 randomized trial () - Jun 19, 2023 - Abstract #RAD2023RAD_117;
P2
There were no differences noted between moderate and severe paVents in the placebo treatment group. In most severity readouts, greater proporVons of AD paVents with severe disease on study entry experienced clinically meaningful improvements with CBP-201.
- ||||| rademikibart (CBP-201) / Suzhou Connect Biopharma
New P2 trial: A Study to Evaluate the Safety and Efficacy of CBP-201 in Chinese Adult Subjects With Moderate to Severe AD (clinicaltrials.gov) - Jun 15, 2023
P2, N=360, Not yet recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
- ||| CBP-201 / Suzhou Connect Biopharma
Enrollment closed, Trial completion date, Trial primary completion date: Efficacy and Safety of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2 Inflammation (clinicaltrials.gov) - Mar 9, 2023
P2, N=306, Active, not recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
In most severity readouts, greater proporVons of AD paVents with severe disease on study entry experienced clinically meaningful improvements with CBP-201. Recruiting --> Active, not recruiting | Trial completion date: Aug 2023 --> Dec 2023 | Trial primary completion date: Jan 2023 --> Aug 2023
- CBP-201 / Suzhou Connect Biopharma
CBP-201, a next-generation IL-4Ra antibody, achieved all primary and secondary efficacy endpoints in the treatment of adults with moderate-to-severe atopic dermatitis (AD): A randomized, double-blind, (New Orleans Theater B) - Mar 4, 2023 - Abstract #AAD2023AAD_3215;
- || CBP-201 / Suzhou Connect Biopharma
Enrollment change, Trial withdrawal, Monotherapy: CBP-201 in Adolescent and Adult Patients With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - Jan 6, 2023
P3, N=0, Withdrawn, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
Recruiting --> Active, not recruiting | Trial completion date: Aug 2023 --> Dec 2023 | Trial primary completion date: Jan 2023 --> Aug 2023 N=450 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| CBP-201 / Suzhou Connect Biopharma
New P3 trial, Monotherapy: CBP-201 in Adolescent and Adult Patients With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - Nov 14, 2022
P3, N=450, Not yet recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
- ||| rademikibart (CBP-201) / Suzhou Connect Biopharma
Enrollment closed, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of CBP-201 in Moderate to Severe Atopic Dermatitis in China (clinicaltrials.gov) - Oct 3, 2022
P2, N=330, Active, not recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
N=450 --> 0 | Not yet recruiting --> Withdrawn Recruiting --> Active, not recruiting | Trial primary completion date: May 2023 --> Jul 2022
- || CBP-201 / Suzhou Connect Biopharma
Trial completion date, Trial primary completion date: A Study Assessing the Efficacy and Safety of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2 Inflammation (clinicaltrials.gov) - Aug 24, 2022
P2, N=306, Recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
Recruiting --> Active, not recruiting | Trial primary completion date: May 2023 --> Jul 2022 Trial completion date: Jan 2023 --> Jul 2023 | Trial primary completion date: Jul 2022 --> Nov 2022
- CBP-201 / Suzhou Connect Biopharma
Investigator-Rated Efficacy Outcomes Across 16 Weeks of Treatment with CBP-201: Results from a Phase 2b Trial in Patients with Atopic Dermatitis (CBP-201-WW001) (e-Poster Hall) - Aug 11, 2022 - Abstract #EADV2022EADV_2318;
- CBP-201 / Suzhou Connect Biopharma
Patient-Reported Efficacy Outcomes Across 16 Weeks of Treatment with CBP-201: Results from a Phase 2b Trial in Patients with Atopic Dermatitis (CBP-201-WW001) (e-Poster Hall) - Aug 11, 2022 - Abstract #EADV2022EADV_2317;
- ||| CBP-201 / Suzhou Connect Biopharma
Trial completion date, Trial termination: A Study to Evaluate CBP-201 in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - Jul 5, 2022
P2, N=40, Terminated, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
Trial completion date: Jan 2023 --> Jun 2022 | Active, not recruiting --> Terminated; Trial was discontinued in 2022 due to COVID-19 pandemic and Ukraine/Russia conflict related enrollment challenges. Discontinuation was not related to safety.
- ||| CBP-201 / Suzhou Connect Biopharma
Enrollment closed, Enrollment change: A Study to Evaluate CBP-201 in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - May 13, 2022
P2, N=40, Active, not recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
Discontinuation was not related to safety. N=147 --> 40 | Recruiting --> Active, not recruiting
- |||| CBP-201 / Suzhou Connect Biopharma
Trial completion, Trial completion date: A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - Feb 28, 2022
P2, N=226, Completed, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
N=147 --> 40 | Recruiting --> Active, not recruiting Active, not recruiting --> Completed | Trial completion date: Mar 2022 --> Oct 2021
- |||| rademikibart (CBP-201) / Suzhou Connect Biopharma
Enrollment open: A Study to Evaluate the Efficacy and Safety of CBP-201 in Moderate to Severe Atopic Dermatitis in China (clinicaltrials.gov) - Sep 23, 2021
P2, N=255, Recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
Active, not recruiting --> Completed | Trial completion date: Mar 2022 --> Oct 2021 Not yet recruiting --> Recruiting
- ||||| rademikibart (CBP-201) / Suzhou Connect Biopharma
New P2 trial: A Study to Evaluate the Efficacy and Safety of CBP-201 in Moderate to Severe Atopic Dermatitis in China (clinicaltrials.gov) - Aug 22, 2021
P2, N=255, Not yet recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
- ||| CBP-201 / Suzhou Connect Biopharma
Enrollment open: A Study to Evaluate CBP-201 in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - Jun 23, 2021
P2, N=147, Recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||| CBP-201 / Suzhou Connect Biopharma
Enrollment open: A Study Assessing the Efficacy and Safety of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2 Inflammation (clinicaltrials.gov) - May 14, 2021
P2, N=306, Recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||| CBP-201 / Suzhou Connect Biopharma
Enrollment closed: A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - Apr 8, 2021
P2, N=220, Active, not recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- |||| CBP-201 / Suzhou Connect Biopharma
New P2 trial: A Study to Evaluate CBP-201 in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - Mar 5, 2021
P2, N=132, Not yet recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
- ||||| CBP-201 / Suzhou Connect Biopharma
New P2 trial: A Study Assessing the Efficacy and Safety of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2 Inflammation (clinicaltrials.gov) - Feb 26, 2021
P2, N=294, Not yet recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
- CBP-201 / Suzhou connect biopharma
[VIRTUAL] A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of The Safety; Pharmacokinetics and Preliminary Efficacy of CBP-201 In Adult Patients with Moderate to severe Atopic Dermatitis () - Oct 20, 2020 - Abstract #EADV2020EADV_1662;
- |||| CBP-201 / Suzhou Connect Biopharma
Enrollment open: A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - Jun 30, 2020
P2, N=220, Recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- ||||| CBP-201 / Suzhou Connect Biopharma
New P2 trial: A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - Jun 24, 2020
P2, N=220, Not yet recruiting, Sponsor: Suzhou Connect Biopharmaceuticals, Ltd.