A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in Subjects With Atopic Dermatitis

• Sponsor: Akeso (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06035354
• Collaborator: (none)
• Enrollment: 416
• Locations: 39
• Arms: 10
• Anticipated Duration (Months): 35.9
• Patients Per Site: 10.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical study to evaluate the safety, pharmacokinetics and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: AK120; Drug: AK120; Drug: Placebo; Drug: AK120; Drug: AK120; Drug: AK120; Drug: Placebo; Drug: AK120; Drug: AK120; Drug: AK120	Phase 1/Phase 2

Detailed Description

This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical study to evaluate the safety, pharmacokinetics and efficacy of AK120 in subjects with moderate to severe atopic dermatitis.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 416 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis
• Actual Study Start Date: Nov 3, 2021
• Anticipated Primary Completion Date: Sep 30, 2024
• Anticipated Study Completion Date: Oct 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AK120 150 mg in phase Ib subcutaneous injection once a week for 4 weeks.	Drug: AK120; subcutaneous injection once a week
Experimental: AK120 300mg in phase Ib subcutaneous injection once a week for 4 weeks.	Drug: AK120; subcutaneous injection once a week
Placebo Comparator: Placebo Comparator: Placebo in phase Ib subcutaneous injection once a week for 4 weeks.	Drug: Placebo; subcutaneous injection once a week.
Experimental: AK120 150mg in phase II subcutaneous injection every 2 weeks for 50 weeks.	Drug: AK120; subcutaneous injection every 2 weeks.
Experimental: AK120 300mg in phase II subcutaneous injection every 2 weeks for 50 weeks.	Drug: AK120; subcutaneous injection every 2 weeks.
Experimental: AK120 450mg in phase II subcutaneous injection every 2 weeks for 50 weeks.	Drug: AK120; subcutaneous injection every 2 weeks.
Placebo Comparator: Placebo Comparator: Placebo in phase II subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 4 and Regimen 5, subcutaneous injection at week 16, after primary endpoint evaluation.	Drug: Placebo; subcutaneous injection every 2 weeks for 16 weeks then crossover to AK120 Regimen 4 and Regimen 5.
Experimental: AK120 150mg in phase II extension subcutaneous injection every 2 weeks for 14 weeks.	Drug: AK120; subcutaneous injection every 2 weeks
Experimental: AK120 300mg in phase II extension subcutaneous injection every 2 weeks for 14 weeks.	Drug: AK120; subcutaneous injection every 2 weeks.
Experimental: AK120 450mg in phase II extension subcutaneous injection every 2 weeks for 14 weeks.	Drug: AK120; subcutaneous injection every 2 weeks.

Outcome Measures

Primary Outcome Measures

1. Phase Ib [Baseline to week 12]

   Incidence of treatment emergent AE . An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.

2. Phase Ib [Baseline to week 12]

   T1/2 of AK120. Assessment of half-life(t1/2) of AK120.

3. Phase Ib [Baseline to week 12]

   AUC of AK120. Assessment of Area under the curve(AUC) of AK120

4. Phase Ib [Baseline to week 12]

   Cmax of AK120. Assessment of Peak concentration(Cmax) of AK120

5. Phase Ib [Baseline to week 12]

   Tmax of AK120. Assessment of Time to peak(Tmax) of AK120

6. Phase II [at week 16]

   Percentage of subjects who achieved (Eczema Area and Severity Index)EASI-75

7. Phase II Extension Study [Baseline to week 24]

   Incidence of treatment emergent AE . An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Secondary Outcome Measures

1. Phase Ib [Baseline to week 12]

   Percentage of subjects with detectable anti AK120 antibodies (ADA).

2. Phase Ib [Baseline to week 12]

   Percentage of subjects who achieved 0/1 in the Investigator's Global Assessment (IGA)(on a 6-point scale) . Lower score of IGA mean better outcome, higher score mean worse outcome

3. Phase II [Baseline to week 58]

   Percentage of subjects who achieved EASI-50 (≥50% improvement from baseline) /EASI-75 (≥75% improvement from baseline) response at each visit. Higher score mean better outcome, lower score mean worse outcome

4. Phase II [Baseline to week 58]

   Percentage change in EASI scores from baseline at each visit. Higher score mean better outcome, lower score mean worse outcome

5. Phase II Extension Study [Baseline to week 24]

   Percentage of subjects who achieved EASI-50 (≥50% improvement from baseline) /EASI-75 (≥75% improvement from baseline) response at each visit. Higher score mean better outcome, lower score mean worse outcome

6. Phase II Extension Study [Baseline to week 24]

   Percentage change in EASI scores from baseline at each visit. Higher score mean better outcome, lower score mean worse outcome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female with age 18 - 75 years (inclusive).

2. Atopic dermatitis (AD) diagnosed at least half an year before screening.

3. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.

4. Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months.

Exclusion Criteria:

1. Suffering from other inflammatory diseases that may affect efficacy outcomes (such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.).

2. History of exposure to active TB, and/or history or current evidence of TB infection.

3. Positive serology results at Screening for hepatitis B, hepatitis C or HIV.

4. Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit.

5. History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit

6. Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with participation in the study, or interfere with the interpretation of study results.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AkesoBio Investigative Site 2037, The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui	China
2	AkesoBio Investigative Site 2036, The First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui	China
3	AkesoBio Investigative Site 1001, Peking University People's Hospital	Beijing	Beijing	China
4	AkesoBio Investigative Site 2044, Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing	China
5	AkesoBio Investigative Site 2023, Xinqiao Hospital Medical University	Chongqing	Chongqing	China
6	AkesoBio Investigative Site 2024, Chongqing Three Gorges Medical College	Chongqing	Chongqing	China
7	AkesoBio Investigative Site 2040, Chongqing Traditional Chinese Medicine Hospital	Chongqing	Chongqing	China
8	AkesoBio Investigative Site 2052, The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing	China
9	AkesoBio Investigative Site 2038, The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	China
10	AkesoBio Investigative Site 2022, Dongguan People's Hospital	Dongguan	Guangdong	China
11	AkesoBio Investigative Site 1002, Guangdong Provincial People's Hospital	Guangzhou	Guangdong	China
12	AkesoBio Investigative Site 2003, Dermatology Hospital of Southern Medical University	Guangzhou	Guangdong	China
13	AkesoBio Investigative Site 2049, The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou	China
14	AkesoBio Investigative Site 2004, The First Affiliated Hospital of Hainan Medical University	Haikou	Hainan	China
15	AkesoBio Investigative Site 2001, Affiliated Hospital of Chengde medical university	Chengde	Hebei	China
16	AkesoBio Investigative Site 2010, Nanyang First People's Hospital National Third Class A Hospital	Nanyang	Henan	China
17	AkesoBio Investigative Site 2051, Jingzhou Central Hospital	Jingzhou	Hubei	China
18	AkesoBio Investigative Site 1005, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China
19	AkesoBio Investigative Site 2046, The Third Xiangya Hospital of Central South University	Changsha	Hunan	China
20	AkesoBio Investigative Site 2008, The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia	China
21	AkesoBio Investigative Site 2048, The First People's Hospital of Changzhou	Changzhou	Jiangsu	China
22	AkesoBio Investigative Site 2050, Wuxi Second People's Hospital	Wuxi	Jiangsu	China
23	AkesoBio Investigative Site 2025, Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu	China
24	AkesoBio Investigative Site 2032, The First Affiliated Hospital of Gannan Medical College	Ganzhou	Jiangxi	China
25	AkesoBio Investigative Site 2011, Northeast International Hospital	Shenyang	Liaoning	China
26	AkesoBio Investigative Site 2039, Shandong Provincial Dermatology Hospital	Jinan	Shandong	China
27	AkesoBio Investigative Site 2041, Qilu Hospital of Shandong University	Jinan	Shandong	China
28	AkesoBio Investigative Site 1003, Shanghai Skin Disease Hospital	Shanghai	Shanghai	China
29	AkesoBio Investigative Site 2027, Medical School of Yanan University	Xianyang	Shanxi	China
30	AkesoBio Investigative Site 2029, West China Hospital，Sichuan University	Chengdu	Sichuan	China
31	AkesoBio Investigative Site 2034, Chengdu Second People's Hospital	Chengdu	Sichuan	China
32	AkesoBio Investigative Site 2013, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital	Tianjin	Tianjin	China
33	AkesoBio Investigative Site 2019, Tianjin Medical University General Hospital	Tianjin	Tianjin	China
34	AkesoBio Investigative Site 2043, First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan	China
35	AkesoBio Investigative Site 1004, Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang	China
36	AkesoBio Investigative Site 2006,Affiliated Hangzhou First People's Hospital	Hangzhou	Zhejiang	China
37	AkesoBio Investigative Site 2007, Hangzhou Third People's Hospital	Hangzhou	Zhejiang	China
38	AkesoBio Investigative Site 2035, The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang	China
39	AkesoBio Investigative Site 2009, The First Hospital of Jiaxing	Jiaxing	Zhejiang	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: NCT06035354
• Other Study ID Numbers: AK120-102
• First Posted: Sep 13, 2023
• Last Update Posted: Sep 13, 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: Dermatitis, Atopic; Dermatitis; Eczema

Study Results

No Results Posted as of Sep 13, 2023