Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis

NCT04785326 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: DMB-3115-2
• Study Type: interventional
• Target: 598
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate to severe chronic plaque psoriasis.

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• • To Evaluate Efficacy of DMB-3115 in Comparison With Stelara

  Percent change in the Psoriasis Area and Severity Index (PASI) score. PASI score is calculated by evaluating the severity of symptoms in each regions of the subject, and produces a numeric score ranging from 0 to 72. The higher the number, the more severe the symptoms. In general, a PASI score of 5 to 10 is considered moderate disease, and a score over 10 is considered severe. The primary endpoint of this clinical trial is % change in PASI, which has a value between 0 and 100, with 100 indicating complete disappearance of symptoms and 0 indicating no improvement in symptoms. If the patient's Baseline PASI score was 10, and 5 at the measurement period, it means that the patient showed 50% reduction.

  Week 8 (For EMA) and 12 (For FDA)

Study Arms (2)

DMB-3115

EXPERIMENTAL

Patients randomized to receive DMB-3115 at the beginning of the study will continue to receive the same treatment

Drug: DMB-3115

Stelara

ACTIVE COMPARATOR

Patients randomized to receive Stelara at the beginning of the study will be re-randomized at Week 28 in a 1:1 ratio to either continue on Stelara or will be transitioned to receive DMB-3115

Drug: DMB-3115; Drug: Stelara

Interventions

DMB-3115 DRUG

45mg or 90mg dose subcutaneous administration

DMB-3115; Stelara

Stelara DRUG

45mg or 90mg dose subcutaneous administration

Stelara

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have a diagnosis of plaque-type psoriasis for at least 6 months.

You may not qualify if:

• Patients with hypersensitivity to ustekinumab or any of the product excipients.

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead
• Meiji Seika Pharma Co., Ltd.: collaborator

Study Sites (2)

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

Jordan Valley Dermatology Center

West Jordan, Utah, 84088, United States

Location

MeSH Terms

Interventions

Ustekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Dong-A ST

imspring@donga.co.kr

02-920-1111

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: April 28, 2021
• Primary Completion: February 10, 2022
• Study Completion: November 16, 2022
• Last Updated: January 18, 2024
• Results First Posted: January 18, 2024

Record last verified: 2024-01

Locations

US (2)