To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque Psoriasis

NCT06061471 | Completed Phase 2

• 1 other identifier: AK111-203
• Study Type: interventional
• Target: 454
• Locations: 1 country
• Sites: 11

Brief Summary

This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis.

Conditions

Psoriasis; Skin Diseases

Outcome Measures

Primary Outcomes (1)

• The percentage of subjects who achieved at least 75% reduction in Psoriasis Area Severity Index （PASI）score from baseline (PASI 75) and the percentage of subjects with sPGA 0/1 at week 16.

  PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%),and severity is estimated by clinical signs, erythema, induration and desquamation: scale 0 (none) to 4 (maximum).Final PASI = sum of severity parameters for each area \* area score weight of section (head: 0.1, arms: 0.2, body: 0.3,legs: 0.4).PASI 50, PASI75 and PASI 90 were defined as participants achieving \>= 50%, \>= 75% or \>= 90% improvement from baseline, respectively.The sPGA is an instrument providing a subjective evaluation of the overall severity of psoriasis, based on severity of induration, scaling, and erythema. The scores are: 0 = clear; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; 5 =severe.

  at week 16

Secondary Outcomes (1)

• The percentage of subjects who achieved at least 90% reduction in PASI score from baseline (PASI 90).

  at week 16

Study Arms (2)

Experimental: AK111 regimen 1

EXPERIMENTAL

Drug: AK111

Experimental: AK111 regimen 2

EXPERIMENTAL

Drug: AK111

Interventions

AK111 DRUG

AK111 regimen 1-subcutaneous injection,until week 24.

Experimental: AK111 regimen 1

Eligibility Criteria

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

You may qualify if:

• Male or female subjects aged ≥18 years old.
• Subjects with moderate to severe plaque psoriasis with or without psoriatic arthritis.
• At screening and baseline, PASI score ≥ 12, BSA ≥ 10%, sPGA ≥ 3.
• Suitable for systematic therapy assessed by investigators.
• Subjects who are women of childbearing potential must be practicing an adequate, medically acceptable method of birth control during the study and for at least 6 months after the last investigational drug administration.

You may not qualify if:

• Types of psoriasis other than chronic plaque-type psoriasis.
• Drug-induced psoriasis.
• Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
• Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
• History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening.
• Progressive or uncontrolled symptoms or signs of circulatory, respiratory, digestive, neuropsychiatric or psychological,hematological, endocrine and other systems before randomization.
• History of malignant tumour within 5 years before screening.
• Previous or current autoimmune diseases.
• Allergic to any component of the investigational drug, or have had severe allergic reactions to monoclonal antibodies.

Sponsors & Collaborators

• Akeso: lead

Study Sites (11)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Location

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Location

Affiliated Hospital of Chengde Medical University

Chengde, Hebei, China

Location

Nanyang First People's hospital national third class a hospital

Nanyang, Henan, China

Location

Yichang central People's hospital

Yichang, Hubei, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

The affiliated hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Dermatology hospital of Jiangxi province

Nanchang, Jiangxi, China

Location

Tianjin academy of traditional Chinese medicine affiliated hospital

Tianjin, Tianjin Municipality, China

Location

Hangzhou First People's hospital

Hangzhou, Zhejiang, China

Location

The first hospital of Jiaxing

Jiaxing, Zhejiang, China

Location

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: September 24, 2023
• First Posted: September 29, 2023
• Study Start: September 22, 2023
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)