The Study of CM326 in Patients With Moderate-to-severe Atopic Dermatitis

NCT05186922 | Unknown Phase 1

• 1 other identifier: CM326AD001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of CM326 in moderate-severe AD subjects.

Conditions

Moderate-to-severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (AE)

  Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

  Up to week 24

Secondary Outcomes (22)

• Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)

  Up to Week 24

• Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)

  Up to Week 24

• Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve (AUC)

  Up to Week 24

• Pharmacokinetics (PK) parameter : Clearance rate (CL/F)

  Up to Week 24

• Pharmacokinetics (PK) parameter : Elimination half life (T1/2z)

  Up to Week 24

Study Arms (6)

CM326 55 mg, once every two weeks (Q2W)

EXPERIMENTAL

55mg for 6 doses, every 2 weeks, subcutaneous (SC)

Biological: CM326

CM326 110 mg, once every two weeks (Q2W)

EXPERIMENTAL

110mg for 6 doses, every 2 weeks, subcutaneous (SC)

Biological: CM326

CM326 110 mg, once every four weeks (Q4W)

EXPERIMENTAL

110mg for 3 doses, every 4 weeks, subcutaneous (SC)

Biological: CM326

CM326 220 mg, once every two weeks (Q2W)

EXPERIMENTAL

220mg for 6 doses, every 2 weeks, subcutaneous (SC)

Biological: CM326

CM326 220 mg, once every four weeks (Q4W)

EXPERIMENTAL

220mg for 3 doses, every 4 weeks, subcutaneous (SC)

Biological: CM326

Placebo

PLACEBO COMPARATOR

Placebo for 6 doses, every 2 weeks, subcutaneous (SC) and placebo for 3 doses, every 4 weeks, subcutaneous (SC)

Other: Placebo

Interventions

CM326 BIOLOGICAL

CM326 injection

CM326 110 mg, once every four weeks (Q4W); CM326 110 mg, once every two weeks (Q2W); CM326 220 mg, once every four weeks (Q4W); CM326 220 mg, once every two weeks (Q2W); CM326 55 mg, once every two weeks (Q2W)

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With confirmed Atopic Dermatitis (AD) at least 12 months before the screening
• Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline
• Investigator's Global Assessment (IGA) score ≥3 at screening and baseline
• Body Surface Area (BSA) of involvement of atopic dermatitis ≥10% at screening and baseline
• The weekly mean score of daily peaks in pruritus NRS at baseline ≥4
• Provide signed informed consent

You may not qualify if:

• Not enough washing-out period for previous therapy.
• Presence of other concomitant and poorly controlled serious diseases or recurrent chronic diseases, including but not limited to active infections, cardiovascular and cerebrovascular diseases, pulmonary tuberculosis or other pathogen infections, diabetes mellitus, autoimmune diseases, human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or parasitosis, neoplasm malignant, etc.
• Patients with severe hepatic or renal impairment, characterized by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level \> 2 times of upper limit of normal (ULN), total bilirubin \>1.5 times of upper limit of normal (ULN) or serum creatinine level \> upper limit of normal (ULN).
• Womens who are pregnant or breastfeeding, or who plan to become pregnant during the study.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

Peking University People's hospital

Beijing, Beijing Municipality, China

RECRUITING

Central Study Contacts

Qian Jia

CONTACT

+862888610620; qianjia@keymedbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 11, 2022
• Study Start: February 17, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: March 9, 2022

Record last verified: 2022-02

Locations

CN (1)