Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis

Sponsor

Botanix Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT03824405

Collaborator

(none)

200

Enrollment

Locations

Arms

12.9

Actual Duration (Months)

6.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: BTX 1204 Drug: Vehicle	Phase 2

Detailed Description

This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD. Eligible subjects will be enrolled and randomized to treatment with BTX 1204 or Vehicle for 84 days. Approximately two hundred (200) subjects will be enrolled. Subjects will receive BID application of study drug for 84 days with a final application on the evening of Day 84 for a total of 168 doses.

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Vehicle-Controlled Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis

Actual Study Start Date :

Feb 4, 2019

Actual Primary Completion Date :

Jan 27, 2020

Actual Study Completion Date :

Mar 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: BTX 1204 BTX 1204 twice daily	Drug: BTX 1204 BTX 1204 liquid formulation
Placebo Comparator: Vehicle Vehicle twice daily	Drug: Vehicle Vehicle liquid formulation

Arm

Intervention/Treatment

Active Comparator: BTX 1204

BTX 1204 twice daily

Drug: BTX 1204

BTX 1204 liquid formulation

Placebo Comparator: Vehicle

Vehicle twice daily

Drug: Vehicle

Vehicle liquid formulation

Outcome Measures

Primary Outcome Measures

Investigator's Global Assessment (IGA) [Day 85]
Investigator's Global Assessment (IGA) success defined as an IGA score of "Clear" (0) or "Almost Clear" (1) with at least a 2-grade improvement

Secondary Outcome Measures

Signs of Atopic Dermatitis [Day 85]
The change from Baseline to Day 85 in the Signs of Atopic Dermatitis score. Signs of atopic dermatitis scale. Total score from 0 to 15 is reported. Signs of atopic dermatitis are assessed on a 4-point scale from non (0) to severe (3).
Body Surface Area [Day 85]
The change from Baseline to Day 85 in the percent of body surface area (BSA) affected by AD
Itch-Numerical Rating Scale [Day 85]
The change from Baseline to Day 85 in the Itch-Numerical Rating Scale (I-NRS). A scale from 0 to 10, where 0 is No itch and 10 is Worst itch imaginable. How would you rate your AVERAGE itch in the past 24 hours?

Other Outcome Measures

Adverse Events [From time of consent through Day 85]
Number of subjects reporting treatment-emergent adverse events (TEAE)

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject is of either gender between 12 and 70 years of age, inclusive.
Subject (or parent/legal guardian) has the ability and willingness to sign a written informed consent.
Subject has a diagnosis of chronic (≥1 year), stable atopic dermatitis (AD)
Subject has ≥ 5% and ≤ 30% body surface area (BSA) of AD involvement excluding the scalp and groin.
Subject has an Investigator's Global Assessment (IGA) score of moderate (3) atopic dermatitis on the 5-point IGA (0-4) scale.
For selected photography sites, subject has a target lesion of 25 to 200 cm2 in surface area on the trunk, upper extremities or lower extremities with a Baseline Signs of AD score of ≥ 6 and ≤ 12.
Subject is in good general health without clinically significant hematological, cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as determined by the investigator.
Subject has suitable venous access for blood sampling.
Subject is able and willing to complete the study and to comply with all study instructions and attend the necessary visits.
Male subjects and their partners must agree and commit to use a barrier method of contraception throughout the study and for 90 days after last study drug application.
A negative urine pregnancy test result for all Women of child bearing potential (WOCBP) at the Screening Visit and Baseline Visit.
Sexually active women must agree to use the following throughout the study and for 30 days after last study drug application. WOCBP who are not sexually active at Baseline and become sexually active must identify a plan for contraception.
One of these highly effective contraception methods Intrauterine device (IUD); hormonal (injections, implants, transdermal patch, vaginal ring); tubal ligation; partner vasectomy, OR
Oral contraceptives WITH a barrier method (listed below), OR
Two barrier forms of contraception (listed below) Male or female condom; diaphragm; cervical cap; contraceptive sponge.
Males subjects must refrain from sperm donation during the study treatment period and until 90 days after last study drug application.

Exclusion Criteria:

Female subject who is breast feeding, pregnant, or planning to become pregnant.
Subject who has an IGA score of 2 (mild) or 4 (severe).
Subject with history of known or suspected intolerance to the drug product excipients.
Subject has any clinically significant active infection in the investigator's opinion. This includes active impetigo at any AD lesion.
Subject has known Hepatitis-B, Hepatitis-C, or HIV infection.
Subject has excessive body or facial hair that would interfere with the evaluation of safety or with the diagnosis or assessment of AD.
Subject has sunburns, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality that would result in the inability to evaluate the AD lesions.
Subject has clinically significant or severe allergies that in the investigator's opinion would interfere with participation in the study.
Subject has known intolerability to topical treatments e.g., reports excessive burning/stinging or pain with use of topical treatments.
Subject has an active or potentially recurring skin conditions(s) other than AD that in the investigator's opinion would interfere with participation in the study.
Subject has unstable AD consistent with a requirement for high-potency corticosteroids.
Subject has used dupilumab (Dupixent) within 12 weeks prior to the Baseline Visit.
Subject has used any biologic therapy, other than dupilumab, within 28 days prior to the Baseline Visit.
Subject has used systemic (oral, IV or IM) corticosteroids within 28 days prior to the Baseline Visit. Intra-articular injection for arthroses allowed.
Subject has used topical anti-pruritics (e.g., PDE4 inhibitors) within 28 days prior to the Baseline Visit.
If subject is taking oral antihistamines, subject has not been on a stable dose of oral antihistamines within 28 days prior to the Baseline visit.
Subject has used phototherapy, tanning beds, or any other artificial light device within 28 days prior to the Baseline Visit.
Subject has used topical corticosteroids within 14 days prior to the Baseline Visit.
Subject has used topical calcineurin inhibitors within 14 days prior to the Baseline Visit.
Subjects has used barrier creams (e.g., Mimyx, Atopiclair), within 7 days prior to the Baseline Visit.
Subject has an underlying disease that requires the use of interfering topical or systemic therapy.
Subject has other dermatological conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, acne or rosacea.
Subject has a clinically relevant history or currently suffering from any disease or condition that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk or interfere with the subject's participation in the study. Subjects with other dermatologic conditions, including genetic syndromes that have an eczematous dermatitis as a component of the disease (e.g., Netherton's) are excluded.
Subject has a clinically relevant history of or current evidence of abuse of alcohol or other drugs.
Subject is currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
Subject has participated in another investigational drug or device research study within 30 days of the Screening Visit or five half-lives of the drug, whichever is longer.
Any other reason that would make the subject, in the opinion of the Investigator or sponsor, unsuitable for the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Applied Research Center of Arkansas Inc.	Little Rock	Arkansas	United States	72212
2	T. Joseph Raoff MD Inc. / Encino Research Center	Encino	California	United States	91436
3	Center for Dermatology Clinical Research	Fremont	California	United States	94538
4	Dermatology Specialist Inc. - Murrieta	Murrieta	California	United States	92562
5	Rady Childern's Hospital - San Diego	San Diego	California	United States	92123
6	Clinical Science Institute	Santa Monica	California	United States	90404
7	Precision Clinical Research	Davie	Florida	United States	33328
8	Troy Sullivan	North Miami Beach	Florida	United States	33162
9	DS Research	Louisville	Kentucky	United States	40241
10	Delright Research	New Orleans	Louisiana	United States	70115
11	Medisearch Clinical Trails	Saint Joseph	Missouri	United States	64506
12	Washington Univerisy in St. Louis	Saint Louis	Missouri	United States	63141
13	JDR Dermatology Research LLC	Las Vegas	Nevada	United States	89148
14	The Acne Treatment and Research Center	Morristown	New Jersey	United States	07960
15	Aventiv Research Inc - Dublin	Dublin	Ohio	United States	43016
16	Greenville Dermatology, LLC	Greenville	South Carolina	United States	29607
17	Dermresearch Inc	Austin	Texas	United States	78759
18	J&S Studies Inc.	College Station	Texas	United States	77845
19	The Center for Skin Research at Suzanne Bruce & Associates Dermatology	Houston	Texas	United States	77056
20	CMAX Clincial Research	Adelaide		Australia	5000
21	BurwoodDermatology	Burwood		Australia	6100
22	Sinclair Dermatology	East Melbourne		Australia	3002
23	North Eastern Health Specialists	Hectorville		Australia	5073
24	Premier Specialists PTY LTD	Kogarah		Australia	2217
25	St George Dermatology & Skin Cancer Center	Kogarah		Australia	2217
26	Captain Stirling Medical Centre	Nedlands		Australia	6009
27	The Skin Hospital	Westmead		Australia	2145
28	Veracity Clinical Research	Woolloongabba		Australia	4102
29	Optilam Clinical Trials	Auckland		New Zealand	1010
30	Clinical Trials New Zealand LTD	Hamilton		New Zealand	3204
31	P3 Research	Wellington		New Zealand	6021