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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05589610




Registration number
NCT05589610
Ethics application status
Date submitted
13/10/2022
Date registered
21/10/2022
Date last updated
12/06/2024

Titles & IDs
Public title
Study of EQ101 in Adult Subjects With Moderate to Severe Alopecia Areata
Scientific title
An Open-label, Phase 2 Study to Assess the Safety and Efficacy of EQ101 in Adult Subjects With Moderate to Severe Alopecia Areata
Secondary ID [1] 0 0
EQ101-104-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alopecia Areata 0 0
Alopecia 0 0
Alopecia Totalis 0 0
Alopecia Universalis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EQ101

Experimental: EQ101 - EQ101 weekly


Treatment: Drugs: EQ101
EQ101, 2 mg/kg, once weekly dosing, for a total of 24 doses
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment Emergent Adverse Events
Timepoint [1] 0 0
Week 28
Secondary outcome [1] 0 0
The efficacy of EQ101 in adult subjects with moderate to severe Alopecia
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
To characterize the pharmacokinetics (PK) of EQ101
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
To characterize the pharmacodynamics (PD) of EQ101
Timepoint [3] 0 0
Week 24

Eligibility
Key inclusion criteria
Key

1.Subjects have AA, meeting all of the following criteria:

1. Clinical diagnosis of AA with no other aetiology of hair loss ;
2. At least 35% scalp hair loss, as defined by a SALT score = 35, at Screening and Baseline. Approximately 25% of subjects with 35% to <50% scalp hair loss and 25% may have AT/AU.
3. Current episode of hair loss lasting > 6 months to < 7 yrs at time of Screening; and
4. No appreciable change in terminal hair regrowth within 6 months of the baseline visit.

Key
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known history of, or currently experiencing, male pattern androgenetic alopecia or female pattern hair loss
2. History of scalp hair transplantation.
3. Other scalp disease that may impact AA assessment or require topical treatment
4. Unwilling to maintain a consistent hair style, including shampoo and hair products, and to refrain from weaves or extensions throughout the course of the study, or shaving of scalp.
5. Use of adhesive or difficult to remove hairpiece or wigs during the study
6. Have undergone significant trauma or major surgery within 8 weeks of the first dose of study drug or considered in imminent need for surgery or with elective surgery scheduled to occur during the study.
7. Participation in other clinical studies involving investigational drug(s) within 4 weeks prior to the baseline visit.
8. Treatment with an oral JAK inhibitor within 6 months prior to the baseline visit.
9. Have previously been treated with an oral JAK inhibitor for AA for at least 12 weeks without achieving at least a 25% improvement in SALT score.
10. Have been treated with any cell-depleting agents including but not limited to rituximab: within 6 months of the baseline visit, or 5 half-lives (if known), or until lymphocyte count returns to normal, whichever is longer.
11. Have been treated with any biologics within 12 weeks or 5 half-lives of the baseline visit, whichever is longer.
12. Have been treated with any oral immune suppressants within 8 weeks of the baseline visit.
13. Have received intralesional injections of corticosteroid or platelet-rich plasma (PRP) in the scalp within 6 weeks of the baseline visit.
14. Have used phototherapy, contact sensitisers, contact irritants, or cryotherapy within 4 weeks of the baseline visit.
15. Have used topical treatments applied to the scalp, eyebrows, or eyelashes (e.g., corticosteroid cream; JAK inhibitors; medicated shampoo; minoxidil (Rogaine); or herbal hair care that could affect AA) within 4 weeks of the baseline visit.
16. Have current or recent history of clinically significant severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality
17. Have a known immunodeficiency disorder.
18. History of solid organ or haematological transplantation.
19. History of a lymphoproliferative disease or malignancy, other than adequately treated non-melanoma skin cancer or cervical carcinoma with no evidence of recurrence.
20. Have active acute or chronic infection
21. Abnormalities in clinical laboratory tests at Screening:

1. Absolute neutrophil count (ANC) <1.0 × 109/L.
2. Liver function tests ( ALT and AST) >3 x ULN.
3. Total bilirubin >1.5 times ULN (unless isolated Gilbert's syndrome)
4. Serum creatinine >1.5 ULN.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2024
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [2] 0 0
Fremantle Dermatology - Fremantle
Recruitment hospital [3] 0 0
Premier Specialists - Kogarah
Recruitment hospital [4] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment postcode(s) [1] 0 0
- East Melbourne
Recruitment postcode(s) [2] 0 0
- Fremantle
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Equillium
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Equillium AUS Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety, PK, and PD of EQ101 as well as measure the efficacy of EQ101 at Week 24 compared to Baseline in adult subjects with moderate to severe AA. The study consists of 3 phases: a screening phase of up to 5 weeks, a treatment phase of 24 weeks, and a follow-up phase of 4 weeks. Study drug will be administered via intravenous (IV) push weekly.
Trial website
https://clinicaltrials.gov/study/NCT05589610
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05589610