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Unknown

[Treatment Period 1]Group 1-Dose1 for Atopic Dermatitis

Phase 3

Waitlist Available

Research Sponsored by Suzhou Connect Biopharmaceuticals, Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week16

Awards & highlights

Study Summary

This is a Phase 3, randomized, double-blinded, placebo-controlled trial in patients, ≥12 years of age who weigh ≥40 kg, and are diagnosed with moderate-to-severe AD.

Eligible Conditions

Atopic Dermatitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week16

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

EASI-75

Investigator Global Assessment(IGA)(0-1)

Secondary outcome measures

Change in Peak Pruritus Numerical Rating Scale（PP-NRS）(in the US)

Change in Peak Pruritus Numerical Rating Scale（PP-NRS）(outside of the US)

Dermatology Life Quality Index(outside of the US)

+3 more

Side effects data

From 2021 Phase 2 trial • 226 Patients • NCT04444752

12%

Dermatitis atopic

COVID-19

Urinary tract infection

Headache

Conjunctivitis

Upper respiratory tract infection

Vomiting

Nausea

Nasopharyngitis

Eye pruritis

Injection site reaction

Pruritis

100%

80%

60%

40%

20%

Study treatment Arm

CBP-201 150 Q2W

CBP-201 300 Q2W

Placebo

CBP-201 300 Q4W

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: [Treatment Period 2] Group 3-DoseExperimental Treatment1 Intervention

Dose 1 and PBO 1 Non-responders, and Group 1 and 2 Non-responders that get open-label Dose 4 or 5 (LD 300 mg or 600 mg, biweekly 300 mg thereafter)

Group II: [Treatment Period 2] Group 1-Dose3Experimental Treatment1 Intervention

CBP-201 300 mg SC Q4W starting at Week 16, alternating with placebo SC Q4W starting at Week 18 with the last dose of CBP-201 at Week 48 and placebo at Week 50

Group III: [Treatment Period 2] Group 1-Dose2Experimental Treatment1 Intervention

CBP-201 300 mg SC Q2W starting at Week 16 with the last dose at Week 50 Treatment Period 2 (Group 1 Dose 1 responder pts that rerandomize to Dose 2, Dose 3, or PBO 2)

Group IV: [Treatment Period 1]Group 1-Dose1Experimental Treatment1 Intervention

CBP-201 600 mg (4 mL) SC on Day 1 (Week 0 visit) visit followed by 300 mg (2 mL) SC Q2W starting at Week 2 with the last dose at Week 14.

Group V: [Treatment Period 1]Goup 2-Placebo1Placebo Group1 Intervention

Placebo (4 mL) SC on Day 0 (Week 0) visit followed by placebo (2 mL) SC Q2W starting at Week 2 with the last dose at Week 14

Group VI: [Treatment Period 2] Group 1-Placebo2Placebo Group1 Intervention

Placebo Q2W SC starting at Week 16 with the last dose at Week 50

Group VII: [Treatment Period 2] Group 2-PlaceboPlacebo Group1 Intervention

PBO 1 pts responders that continue PBO 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CBP-201

2020

Completed Phase 2

~880

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Suzhou Connect Biopharmaceuticals, Ltd.Lead Sponsor

10 Previous Clinical Trials

1,929 Total Patients Enrolled

Suzhou ConnectStudy DirectorSuzhou Connect Biopharmaceuticals, Ltd.

10 Previous Clinical Trials

1,939 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for participants in this trial?

"No, this particular trial is not recruiting right now. Although the last update on clinicaltrials.gov was on November 6th, 2022, it's possible that the status of the trial has changed since then. There are plenty of other medical studies seeking participants though; as many as 257 at present."

Answered by AI

Is this clinical trial being conducted at more than one location within the state?

"If you're interested in enrolling in this study, know that there are 9 recruitment sites. They are situated in Flossmoor, Lancaster, Little Rock and other locations. To make the process as easy as possible for enrollees, it is best to choose a trial site nearest to your location."

Answered by AI

Are there any immediate dangers associated with [Treatment Period 2] Group 3-Dose?

"[Treatment Period 2] Group 3-Dose was given a score of 3, which is based on the available data from Phase 3 clinical trials that suggest both efficacy and safety."

Answered by AI

What are the goals of this clinical trial?

"The purpose of this study is to track improvement in patients' Eczema Area and Severity Index (EASI) scores over a 16-week period. The secondary outcomes being measured include the proportion of participants who achieve a 90% reduction in their EASI score (EASI-90), the change in Peak Pruritus Numerical Rating Scale score (PP-NRS) for participants outside of the United States, and the Investigator Global Assessment score (IGA) for participants outside of the United States."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CBP-201 in Adolescent and Adult Patients With Moderate-to-severe Atopic Dermatitis

2022. "CBP-201 in Adolescent and Adult Patients With Moderate-to-severe Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05614817.