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

NCT05614817 | Withdrawn Phase 3 DMC FDA Drug

• 2 other identifiers: CBP-201-WW0042022-000999-19
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atopic Dermatitis

Keywords

Eczema; allergic dermatitis; pruritis; type 2 inflammation; allergy

Outcome Measures

Primary Outcomes (2)

• Investigator Global Assessment(IGA)(0-1)

  The proportion of participants whose IGA score is 0-1 and decreased by ≥2 points

  Baseline to Week16

• EASI-75

  The proportion of participants achieving EASI-75

  Baseline at Week 16

Secondary Outcomes (6)

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

  Baseline at Week16

• Investigator Global Assessment(IGA)(0-1) (outside of the US)

  Baseline at Week16

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

  Baseline at Week16

• Scoring Atopic Dermatitis(outside of the US)

  At Week16

• Dermatology Life Quality Index(outside of the US)

  Baseline at Week16

Study Arms (7)

[Treatment Period 1]Group 1-Dose1

EXPERIMENTAL

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.

Drug: CBP-201

[Treatment Period 1]Goup 2-Placebo1

PLACEBO COMPARATOR

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

Drug: Placebo

[Treatment Period 2] Group 1-Dose2

EXPERIMENTAL

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)

Drug: CBP-201

[Treatment Period 2] Group 1-Dose3

EXPERIMENTAL

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

Drug: CBP-201

[Treatment Period 2] Group 1-Placebo2

PLACEBO COMPARATOR

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

Drug: Placebo

[Treatment Period 2] Group 2-Placebo

PLACEBO COMPARATOR

PBO 1 pts responders that continue PBO 1

Drug: Placebo

[Treatment Period 2] Group 3-Dose

EXPERIMENTAL

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)

Drug: CBP-201

Interventions

CBP-201 DRUG

CBP-201 subcutaneous(SC) injection

[Treatment Period 1]Group 1-Dose1; [Treatment Period 2] Group 1-Dose2; [Treatment Period 2] Group 1-Dose3; [Treatment Period 2] Group 3-Dose

Placebo DRUG

subcutaneous(SC) injection

[Treatment Period 1]Goup 2-Placebo1; [Treatment Period 2] Group 1-Placebo2; [Treatment Period 2] Group 2-Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent or assent (as per local law).
• Adults and adolescents of any sex or gender (12 years of age or older)
• Body weight ≥ 40 kg at Screening
• Diagnosis of chronic Atopic Dermatitis as defined according to American Academy of Dermatology Consensus Criteria (Eichenfield 2014), present ≥ 3 year before Screening.
• Atopic Dermatitis history with ALL the following disease activity criteria:
• Involvement of ≥ 10% BSA at Screening and Baseline (Day 1).
• An EASI score of ≥ 16 at Screening and Baseline (Day 1).
• An IGA score of ≥ 3 at Screening and Baseline (Day 1).
• Baseline weekly average of daily PP-NRS ≥ 4 at Baseline (Day1).
• Participant has applied a Sponsor approved emollient twice a day for at least 14 days before the Baseline Visit and agree to continue at least daily use during study participation.
• Documented recent history (within 180 days before Screening) of inadequate response to treatment with TCS or topical immunomodulator medication or for whom topical treatments are otherwise medically inadvisable (e.g., important side effects or safety risks).
• Participants must agree to avoid the use of prohibited AD medications throughout the duration of the study.
• In the opinion of the Investigator, participant is willing and able to comply with all study visits and study-related procedures.
• Female patients of childbearing potential who are sexually active with a non-sterilized male partner should have a confirmed negative serum beta-human chorionic gonadotropin test at Visit 1 and agrees to use acceptable forms of birth control.

You may not qualify if:

• No current or past history of:
• Other active skin diseases (e.g., psoriasis, lupus erythematosus etc.) or skin infections (bacterial, fungal, or viral) that require systemic treatment within 4 weeks of Screening Visit or would interfere with the assessment of AD lesions.
• History of recurrent herpes herpeticum in the prior 12 months or more than 2 episodes of herpes herpeticum in past 2 years.
• Non-skin related active infection requiring systemic treatment with parenteral anti-infectives within 30 days or oral anti-infectives within 14 days before the Baseline Visit (Visit 2).
• Active human immunodeficiency virus (HIV) defined as a confirmed positive anti-HIV antibody test.
• Tuberculosis requiring treatment within the past 12 months before Screening. Note: Evaluation of tuberculosis will be according to local guidelines as per standard of care.
• Active Hepatitis B virus (HBV) or hepatitis C virus (HCV).
• HCV: HCV ribonucleic acid (RNA) detectable in any subject with anti-HCV antibody (HCV Ab).
• Participant may not have any of the following conditions:
• Known primary immunodeficiency or immunocompromised
• History of malignancy within 5 years before the Screening Visit except for completely treated in situ carcinoma of the cervix or completely treated and resolved basal cell carcinoma of the skin.
• A helminth parasitic infection diagnosed within 6 months before Visit 1 that has not been treated with or has failed to respond to standard of care therapy.
• History of chronic alcohol or drug abuse including chronic use of cannabis (e.g., inhalation and/or consumption of marijuana more than once per week) within 12 months before screening.
• History of attempted suicide or is at significant risk of suicide.
• History of anaphylaxis after administration of a biologic medication or vaccine.

Sponsors & Collaborators

• Connect Biopharm LLC: lead

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Pruritus; Hypersensitivity

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzhou Connect

  Connect Biopharm LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: November 14, 2022
• Study Start: December 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: July 1, 2025
• Last Updated: March 21, 2023

Record last verified: 2023-01