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

• Sponsor: Akeso (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06066125
• Collaborator: (none)
• Enrollment: 350
• Locations: 34
• Arms: 3
• Anticipated Duration (Months): 18.1
• Patients Per Site: 10.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis; Skin Diseases	Drug: AK111; Drug: AK111; Drug: Placebo	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Mar 31, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AK111 regimen 1	Drug: AK111; AK111 regimen 1- subcutaneous injection at week 0,1,2, 3,4 and every 4 weeks thereafter until week 48. The primary endpoint will be evaluated at week 12 and followed up to week 56.
Experimental: AK111 regimen 2	Drug: AK111; AK111 regimen 2- subcutaneous injection at week 0,1,2, 3,4 and every 4 weeks thereafter until week 48. The primary endpoint will be evaluated at week 12 and followed up to week 56.
Placebo Comparator: Placebo	Drug: Placebo; Placebo- subcutaneous injection at week 0,1,2, 3, 4 and week 8. AK111 regimen 2-subcutaneous injection every 4 weeks from week 12 to week 48. The primary endpoint will be evaluated at week 12 and followed up to week 56.

Outcome Measures

Primary Outcome Measures

1. The percentage of subjects who achieved at least 75% reduction in psoriasis area and severity index(PASI) score from baseline (PASI 75) and the percentage of subjects who achieved static physician global assessment(sPGA) 0/1 at week 12. [at week 12]

   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.

Secondary Outcome Measures

1. The percentage of subjects who achieved at least 90% reduction in PASI score from baseline (PASI 90) at week 12. [at week 12]

2. The percentage of subjects who achieved PASI 75 and the percentage of subjects who achieved sPGA 0/1 at week 52. [at week 52]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The first affiliated hospital of Bengbu Medical College	Bengbu	Anhui	China
2	The first affiliated hospital of wannan medical college	Wannan	Anhui	China
3	Affiliated hospital of Chongqing Three Gorges Medical College	Chongqing	Chongqing	China
4	Chongqing traditional Chinese medicine hospital (Daomenkou branch)	Chongqing	Chongqing	China
5	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China
6	Shenzhen People's hospital	Shenzhen	Guangdong	China
7	The first affiliated hospital of Hainan Medical university	Haikou	Hainan	China
8	Nanyang First People's hospital national third class a hospital	Nanyang	Henan	China
9	Renmin hospital of Wuhan University Hubei general hospital	Wuhan	Hubei	China
10	Yichang central People's hospital	Yichang	Hubei	China
11	The third Xiangya hospital of Central South University	Changsha	Hunan	China
12	The frist People's hospital of Lianyungang	Lianyungang	Jiangsu	China
13	Dermatology Hospital of China Union Medical University	Nanjing	Jiangsu	China
14	The affiliated hospital of Xuzhou Medical University	Xuzhou	Jiangsu	China
15	Yancheng No.1 People's hospital	Yancheng	Jiangsu	China
16	Dermatology hospital of Jiangxi province	Nanchang	Jiangxi	China
17	The second hospital of Dalian Medical University	Dalian	Liaoning	China
18	Second hospital of Shanxi Medical University	Taiyuan	Shanxi	China
19	Tangdu hospital of the Fourth Military Medical University	Tanggu	Shanxi	China
20	West China school of medicine, West China hospital of Sichuan University	Chengdu	Sichuan	China
21	Tianjin academy of traditional Chinese medicine affiliated hospita	Tianjin	Tianjin	China
22	Tianjin Medical University general hospital	Tianjin	Tianjin	China
23	Hangzhou first People's hospital	Hangzhou	Zhejiang	China
24	The first hospital of Jiaxing	Jiaxing	Zhejiang	China
25	Ningbo Huamei hospital, University of Chinese Academy of Sciences	Ningbo	Zhejiang	China
26	The first affiliated hospital of Wenzhou Medical University	Wenzhou	Zhejiang	China
27	Beijing friendship hospital, Capital Medical University	Beijing		China
28	Peking University third hospital	Beijing		China
29	Guangdong provincial people's hospital	Guangdong		China
30	Affiliated hospital of Chengde Medical University	Hebei		China
31	The second affiliated hospital of Harbin Medical University	Heilongjiang		China
32	Xiangya hospital Central South University	Hunan		China
33	Huashan hospital, Fudan University	Shanghai		China
34	Shanghai skin disease hospital	Shanghai		China

Sponsors and Collaborators

• Akeso

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Akeso
• ClinicalTrials.gov Identifier: NCT06066125
• Other Study ID Numbers: AK111-301
• First Posted: Oct 4, 2023
• Last Update Posted: Oct 4, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Psoriasis; Skin Diseases

Study Results

No Results Posted as of Oct 4, 2023