A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis

Akeso

Status and phase: Completed; Phase 3

Conditions: Psoriasis; Skin Diseases

Treatments: Drug: Placebo; Drug: AK111

Study type: Interventional

Funder types: Industry

Identifiers

NCT06066125

AK111-301

Details and patient eligibility

About

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

Full description

This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis. Subjects will be randomized to receive AK111 or placebo subcutaneously and followed up to week 56.

Enrollment: 351 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subjects aged ≥18 years old.
2. Subjects diagnosed with moderate to severe plaque psoriasis with or without psoriatic arthritis.
3. At screening and baseline, PASI score ≥ 12 , Body Surface Area(BSA) ≥ 10%, sPGA ≥ 3.
4. Suitable for systematic therapy assessed by investigators.
5. Subjects who are women of childbearing potential must have a negative pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control during the study and for at least 6 months after the last study drug administration.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

351 participants in 3 patient groups, including a placebo group

AK111 regimen 1

Experimental group

Treatment:

Drug: AK111

Drug: AK111

AK111 regimen 2

Experimental group

Treatment:

Drug: AK111

Drug: AK111

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo