Clinical trial • Phase II • Dermatology

LAD603 for Alopecia areata

Phase II trial of LAD603 for Alopecia areata.

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Alopecia areata
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
25-11-2025
First CTIS Authorization Date
24-03-2026

Trial design

Randomised, placebo for lad603 (placebo comparator); no dose or schedule specified in the public data-controlled Phase II trial in Bulgaria, Germany, Romania and others.

Randomised
Yes
Comparator
Placebo for LAD603 (placebo comparator); no dose or schedule specified in the public data
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
118
Trial Duration For Participant
196

Eligibility

Recruits 118 No vulnerable populations selected. Adults only (18-65). Written informed consent is required from participants; no assent procedures for minors are mentioned..

Pregnancy Exclusion
Participants who are WOCBP or male must agree to the requirements for the avoidance of pregnancy and exposure of the participant’s partner to LAD603 during the study
Vulnerable Population
No vulnerable populations selected. Adults only (18-65). Written informed consent is required from participants; no assent procedures for minors are mentioned.

Inclusion criteria

  • {"criterion_text":"- Subject is a male or female between 18 and 65 years old at the time of signing the informed consent.\n- Subject is able to understand and willing to comply with study requirements as per Investigator’s opinion.\n- Subject provides written informed consent in accordance with institutional and regulatory guidelines, prior to any study-related procedures being performed.\n- AA criteria: a) Patchy scalp hair loss (including ophiasis or sisaipho variants), alopecia totalis (AT), or alopecia universalis (AU): AT is defined as complete (100%) scalp hair loss. AU is defined as complete (100%) scalp, facial, and body hair loss. b) ≥50% hair loss of the scalp as measured by SALT without evidence of terminal hair regrowth within 6 months at both the Screening and Baseline (Day 1) visits. c) Current episode of hair loss lasting at least 6 months and not exceeding 7 years.\n- Participants who are WOCBP or male must agree to the requirements for the avoidance of pregnancy and exposure of the participant’s partner to LAD603 during the study"}

Exclusion criteria

  • {"criterion_text":"- Subjects have other types of alopecia (including but not limited to traction, scarring alopecia).\n- Subjects with \"diffuse\" type AA\n- History of male or female-pattern hair loss (>Hamilton stage III or >Ludwig stage II).\n- Subjects with history or presence of hair transplants.\n- Use of adhesive wigs, other than banded perimeter wigs, during the study.\n- Currently has an active form of other inflammatory skin disease(s) or evidence of skin condition (eg, psoriasis, seborrheic dermatitis, lupus) at the time of the Screening or Baseline (Day 1) visits that is expected to interfere with the assessment of alopecia areata severity. (For the avoidance of doubt, when no interference is expected, subjects could participate if they are otherwise eligible, including adhering to the allowed/permitted medication requirements.)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percent change from baseline in the SALT score, at Week 28.","definition_or_measurement_approach":"Measured as percent change from baseline in the SALT (Severity of Alopecia Tool) score at Week 28."}

Recruitment

Digital Remote Recruitment
True, social media posts and social media stories are listed for Poland (K2_POL05432). Some countries have electronic subject materials (e.g. Romania subject materials in English) documented.
Planned Sample Size
118
Recruitment Window Months
20
Consent Approach
Written informed consent is required from participants prior to any study-related procedures. Consent is provided by adult participants (18-65). Country-specific ICFs are available (L1 country ICF Main Adult) in English and in local languages where provided (Bulgarian, German, Romanian, Spanish, Polish). Separate pregnant-form ICFs are available for countries where provided.

Methods

  • Bulgaria: Recruitment Procedure Description, Recruitment Brochure, Flip Chart, Information Letter (site-based materials) — channels documented in K1_BGR and K2_BGR.
  • Germany: Recruitment Procedure Description, Recruitment Brochure, Dear Patient Letter, Flip Chart (site-based materials) — documented in K1_DEU and K2_DEU.
  • Romania: Recruitment Procedure Description, Recruitment Brochure, Flip Chart, Information Letter and English subject materials (site materials) — documented in K1_ROU and K2_ROU.
  • Spain: Recruitment Procedure Description, Recruitment Brochure, Dear Patient Letter, Flip Chart (site-based materials) — documented in K1_ESP and K2_ESP.
  • Poland: Recruitment Procedure Description, Recruitment Brochure, Flip Chart, Information Letter, recruitment flyer and social media assets (social media post and social media story) — documented in K1_POL and K2_POL05432.

Geography

Total Number Of Sites
26
Total Number Of Participants
118

Bulgaria

Earliest CTIS Part Ii Submission Date
23-03-2026
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
7
Number Of Sites
4
Number Of Participants
24

Sites

Site Name
Medical Center I Stamboliyski
Department Name
BGR05433
Contact Person Name
Kseniya Baadzhi
Contact Person Email
kseniya.ba@yahoo.com
Site Name
Medical Center Excelsior OOD
Department Name
BGR05443
Contact Person Name
Todor Popov
Contact Person Email
ted.popov@gmail.com
Site Name
Medical Center Medconsult Pleven OOD
Department Name
BGR03291: Dermatology
Contact Person Name
Kamelia Vekovska
Contact Person Email
kvekovska_medconsult@abv.bg
Site Name
Medical Center Medconsult Pleven OOD
Department Name
BGR03292
Contact Person Name
Krasimira Vasileva
Contact Person Email
vasileva_mclovech@abv.bg

Germany

Earliest CTIS Part Ii Submission Date
13-03-2026
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
12
Number Of Sites
7
Number Of Participants
22

Sites

Site Name
Technische Universitaet Dresden
Department Name
DEU03341: Klinik und Poliklinik für Dermatologie
Contact Person Name
Roland Aschoff
Contact Person Email
roland.aschoff@ukdd.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
DEU02476: Hautklinik
Contact Person Name
Lukas Sollfrank
Contact Person Email
Lukas.Sollfrank@uk-erlangen.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
DEU05425: Clinical Research Center for Hair and Skin Science (CRC)
Contact Person Name
Ulrike Blume-Peytavi
Site Name
Universitaet Muenster
Department Name
DEU03294: ZID
Contact Person Name
Nina Magnolo
Contact Person Email
nina.magnolo@ukmuenster.de
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
DEU02816: Klinisches Studienzentrum
Contact Person Name
Athanasios Tsianakas
Contact Person Email
a.tsianakas@fk-bentheim.de
Site Name
Klinische Forschung Osnabrueck
Department Name
DEU03298: Klinische Forschung Osnabrück
Contact Person Name
Sylvia Pauser
Contact Person Email
sylvia.pauser@klifos.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
DEU01381: Institut für Entzündungsmedizin, Haus V50
Contact Person Name
Diamant Thaci
Contact Person Email
diamant.thaci@uksh.de

Romania

Earliest CTIS Part Ii Submission Date
26-02-2026
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
32
Number Of Sites
3
Number Of Participants
24

Sites

Site Name
Futuremeds S.R.L.
Department Name
ROM05442: Dermatology
Contact Person Name
Mihaela Jian
Contact Person Email
ancajian@yahoo.com
Site Name
San Medica S.R.L.
Department Name
ROM05423
Contact Person Name
Cristina Zimbrea
Site Name
Centrul Medical Sana S.R.L.
Department Name
ROM05439
Contact Person Name
Horia Beti
Contact Person Email
horia.beti@sana.ro

Spain

Earliest CTIS Part Ii Submission Date
26-02-2026
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
27
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Icr Medical S.L.
Department Name
ESP05441: Dermatology
Contact Person Name
David Saceda Corralo
Contact Person Email
d.saceda@gmail.com
Site Name
Hospital General Universitario Dr. Balmis
Department Name
ESP05444: Dermatology
Contact Person Name
Maria del Mar Blanes Martinez
Contact Person Email
marblanes76@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
ESP05440: Dermatology
Contact Person Name
Victor Cabezas Calderon
Contact Person Email
victor.cabezas@vallhebron.cat
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
ESP05403: Dermatology
Contact Person Name
Lara Ferrandiz Pulido
Contact Person Email
lferrandiz.eecc@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
26-02-2026
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
26
Number Of Sites
8
Number Of Participants
34

Sites

Site Name
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Department Name
POL05434: Dermatology
Contact Person Name
Anna Kacalak-Rzepka
Contact Person Email
kacalak@twojaprzychodnia.com
Site Name
Dermedic Jacek Zdybski
Department Name
POL05424: Dermatology
Contact Person Name
Jacek Zdybski
Contact Person Email
jacek@zdybski.pl
Site Name
Dermaceum Sp. z o.o.
Department Name
POL05421: Dermatology
Contact Person Name
Michal Torz
Contact Person Email
m.torz@ginemedica.pl
Site Name
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Paweł Brzewski S.C.
Department Name
POL05435: Dermatology
Contact Person Name
Pawel Brzewski
Contact Person Email
brzewski@sgd-polska.com
Site Name
Royalderm Sp. z o.o.
Department Name
POL05422: Dermatology
Contact Person Name
Agnieszka Nawrocka
Contact Person Email
anawrocka@royalderm.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
POL03295: Dermatology
Contact Person Name
Malgorzata Plocka
Contact Person Email
m.plocka@naszlekarz.pl
Site Name
Provita Sp. z o.o.
Department Name
POL03293: Dermatology
Contact Person Name
Anita Lewartowska-Bialek
Contact Person Email
bialek.anita@gmail.com
Site Name
Gyncentrum Sp. z o.o.
Department Name
POL05432: Dermatology
Contact Person Name
Marcin Zakrzewski
Contact Person Email
m.zakrzewski@gyncentrum.pl

Sponsor

Primary sponsor

Full Name
Almirall S.A.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Spain

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
codes: 1,10,11,12,15 (Pharmacokinetics),2,5,6,8,9

Third parties

  • {"country":"United Kingdom","full_name":"Medical Research Network Limited","duties_or_roles":"Home nursing","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"codes: 1,10,11,12,15 (Pharmacokinetics),2,5,6,8,9","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"codes: 3,7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Imaging services","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Nuvisan GmbH","duties_or_roles":"Pharmacokinetics and ADA","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Eurofins Central Laboratory B.V.","duties_or_roles":"Laboratory services (code 4)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA and ECG services","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CluePoints","duties_or_roles":"Data Surveillance Platform","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
LAD603
Active Substance
LAD603
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
Subcutaneous injection
Authorisation Status
Investigational medicinal product
Investigational Product Name
Placebo for LAD603
Modality
Other

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