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ANT-1207

Phase 2

Hyperhidrosis | Monoclonal antibody | Dermatology |AbbVie Inc.|Last Updated: Sep 20, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment145

FDA Designations

No designations recorded

Clinical trial landscape

ANT-1207 · 1 trial · 1 indication

Phase 2 1
NCT02479139Clinical Trial To Evaluate ANT-1207 In Participants With Primary Axillary HyperhidrosisHyperhidrosis
COMPLETED145 Analytics
PHASE2COMPLETED
Clinical Trial To Evaluate ANT-1207 In Participants With Primary Axillary Hyperhidrosis
HyperhidrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Both a Change From Baseline in Hyperhidrosis Disease Severity Scale (HDSS) Score by ≥ 2 Points and a Change From Baseline in Gravimetric Sweat Production (GSP) by ≥ 50%
Baseline, Week 12

The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities. GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. The HDSS and the GSP were assessed at Baseline and Week 12. The change from Baseline was calculated. The percentage of participants who had both a change (reduction) from Baseline in HDSS score by ≥ 2 points and a change (reduction) from Baseline in GSP by ≥ 50% is reported.

Secondary Endpoints

Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points
Baseline, Weeks 4, 8, 12 and 18
Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50%
Baseline, Weeks 4, 8, 12 and 18
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VehiclePLACEBO_COMPARATORVehicle for botulinum toxin Type A topical liniment (ANT-1207) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
ANT-1207 Dose 1EXPERIMENTALBotulinum toxin Type A topical liniment (ANT-1207) Dose 1 (lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
ANT-1207 Dose 2EXPERIMENTALBotulinum toxin Type A topical liniment (ANT-1207) Dose 2 (second lowest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
ANT-1207 Dose 3EXPERIMENTALBotulinum toxin Type A topical liniment (ANT-1207) Dose 3 (mid-level dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
ANT-1207 Dose 4EXPERIMENTALBotulinum toxin Type A topical liniment (ANT-1207) Dose 4 (second highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.
ANT-1207 Dose 5EXPERIMENTALBotulinum toxin Type A topical liniment (ANT-1207) Dose 5 (highest dose) applied topically in a volume of 12 drops per axilla (armpit) once on Day 0.

Interventions

NameTypeDescription
VehicleBIOLOGICALVehicle for ANT-1207 liniment formulation without active ingredient.
ANT-1207BIOLOGICALBotulinum toxin Type A topical liniment (ANT-1207).
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * ages 18 - 70 years of age * diagnosis of primary axillary hyperhidrosis * HDSS score of ≥3 * threshold sweat production/axilla in 5 minutes as measured gravimetrically * willingness to shave underarms prior to each study visit Exclusion Criteria: * botulinum toxin treatment ...

Countries:United States
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Frequently asked questions about ANT-1207

What is ANT-1207 used for?

ANT-1207 is an investigational monoclonal antibody being developed for hyperhidrosis, a condition of excessive sweating. It is specifically being studied for primary axillary hyperhidrosis, which involves excessive underarm sweating.

What does ANT-1207 target?

ANT-1207 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied for its potential to treat hyperhidrosis, though the exact mechanism of action is not publicly detailed.

Who makes ANT-1207?

ANT-1207 is being developed by AbbVie Inc. (NYSE: ABBV), a biopharmaceutical company. The drug is currently in clinical development for hyperhidrosis.

What phase is ANT-1207 in?

ANT-1207 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.

What clinical trials is ANT-1207 in?

ANT-1207 has one completed Phase 2 clinical trial, identified as NCT02479139, which evaluated the drug in participants with primary axillary hyperhidrosis. The trial enrolled 145 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is ANT-1207 the same as any other drug?

No alternative names for ANT-1207 have been disclosed. It is identified solely by its code name ANT-1207 in clinical development.