NCT06018428

Brief Summary

Part A is a randomized, double-blind, placebo-controlled, multi-center Proof-of-Concept (POC) Trial in subjects with severe Alopecia Areata. All participants in Part A have completed participation. Part B is a multicenter, open-label study to assess the efficacy, safety, and tolerability of bempikibart (ADX-914) in participants with severe Alopecia Areata.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
2mo left

Started Sep 2023

Typical duration for phase_2

Geographic Reach
2 countries

33 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Sep 2023Sep 2026

First Submitted

Initial submission to the registry

August 15, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

September 12, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

2.7 years

First QC Date

August 15, 2023

Last Update Submit

May 5, 2026

Conditions

Alopecia Areata

Keywords

Areata, AlopeciaAlopeciaDermatitisHair LossTrichoscopyAtopic

Outcome Measures

Primary Outcomes (2)

  • Part A: Mean relative percent change in SALT score

    Part A: Mean relative percent change in SALT score at 24 weeks compared with baseline

    24 Weeks

  • Part B: Mean percent change from baseline in SALT score

    Part B: Mean percent change from baseline in SALT score at Week 36

    36 weeks

Secondary Outcomes (9)

  • Part A: Mean relative percentage change SALT score compared with baseline at Weeks 6,12, and 18.

    18 Weeks

  • Part A: Mean relative percentage change in SALT score at 24 weeks compared with treatment nadir.

    24 Weeks

  • Part A: Absolute change in SALT score compared with baseline at Weeks 6, 12, 18, and 24.

    24 Weeks

  • Part A: Proportion of participants who achieve ≥30% and ≥50% relative reduction in SALT score compared with baseline at Weeks 12, 18, and 24.

    24 Weeks

  • Part A: Proportion of participants with absolute SALT score ≤5, ≤10, ≤20, and ≤30 at Weeks 12, 18, and 24.

    24 Weeks

  • +4 more secondary outcomes

Study Arms (1)

Experimental: bempikibart (ADX-914)

EXPERIMENTAL

200mg dose of bempikibart (ADX-914) administered via injection under the skin

Drug: bempikibart (ADX-914)

Interventions

bempikibart (ADX-914)DRUG

Subcutaneous administration of bempikibart (ADX-914)

Experimental: bempikibart (ADX-914)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult men and women, aged 18 to 75 years, inclusive, at the time of informed consent.
  • Clinical diagnosis of severe to very severe alopecia areata, defined as the presence of ≥50% total scalp hair loss at screening and baseline as measured by the SALT score.

You may not qualify if:

  • History of or diagnosis at screening of any another form of alopecia based on assessment by investigator.
  • History (lifetime) or presence of hair transplants.
  • History (lifetime) or presence of micropigmentation of the scalp (Note: Microblading of the eyebrows is permitted).
  • Use of systemic, topical, or device-based therapy for AA.
  • History of, recent, or current clinically serious viral, bacterial, fungal, or parasitic infection or mycobacterial infection or at risk of serious infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Scottsdale, Arizona

Scottsdale, Arizona, 85255, United States

Location

Fayetteville, Arkansas

Fayetteville, Arkansas, 72703, United States

Location

Hot Springs, Arkansas

Hot Springs, Arkansas, 71913, United States

Location

Encinitas, California

Encinitas, California, 92024, United States

Location

Fountain Valley, California

Fountain Valley, California, 92708, United States

Location

Lomita, California

Lomita, California, 90717, United States

Location

New Haven, Connecticut

New Haven, Connecticut, 06519, United States

Location

Miami, Florida

Miami, Florida, 33173, United States

Location

Tampa, Florida

Tampa, Florida, 33613, United States

Location

Clarksville, Indiana

Clarksville, Indiana, 47129, United States

Location

Bowling Green, Kentucky

Bowling Green, Kentucky, 42104, United States

Location

Burlington, Massachusetts

Burlington, Massachusetts, 01805, United States

Location

Troy, Michigan

Troy, Michigan, 48084, United States

Location

Warren, Michigan

Warren, Michigan, 48192, United States

Location

New York, New York

New York, New York, 10012, United States

Location

New York, New York

New York, New York, 10023, United States

Location

Wilmington, North Carolina

Wilmington, North Carolina, 28405, United States

Location

Bexley, Ohio

Bexley, Ohio, 43209, United States

Location

Clinical Trials

Canton, Ohio, 44718, United States

Location

Mason, Ohio

Mason, Ohio, 45040, United States

Location

Mayfield Heights, Ohio

Mayfield Heights, Ohio, 44124, United States

Location

Portland, Oregon

Portland, Oregon, 97225, United States

Location

Austin, Texas

Austin, Texas, 78759, United States

Location

Frisco, Texas

Frisco, Texas, 75034, United States

Location

Houston, Texas

Houston, Texas, 77056, United States

Location

San Antonio, Texas

San Antonio, Texas, 78213, United States

Location

Jordan, Utah

Jordan, Utah, 84095, United States

Location

Spokane, Washington

Spokane, Washington, 99202, United States

Location

Clinical Trials

Calgary, Alberta, T1Y 0B4, Canada

Location

Clinical Trials

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Clinical Trials

Oakville, Ontario, L6J 7W5, Canada

Location

Clinical Trials

Peterborough, Ontario, K9J 5K2, Canada

Location

Clinical Trials

Waterloo, Ontario, N2J 1C4, Canada

Location

MeSH Terms

Conditions

Alopecia AreataAlopeciaDermatitis

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Masking Details
Part A was double blind-randomized. Part B and OLE are open label.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 30, 2023

Study Start

September 12, 2023

Primary Completion

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Locations

US(28)CA(5)