NCT04499235 is a Phase 2 clinical trial of Mometasone furoate in Pemphigoid, Bullous, sponsored by Alkahest, Inc..

Who is sponsoring NCT04499235?

NCT04499235 is sponsored by Alkahest, Inc..

What drugs are being tested in NCT04499235?

Interventions in NCT04499235: Mometasone furoate, AKST4290, Placebo.

What condition does NCT04499235 study?

NCT04499235 studies Pemphigoid, Bullous.

Is NCT04499235 still recruiting?

NCT04499235 is currently terminated. Last updated 14 September 2023.

Are results published for NCT04499235?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-09-14 · How we verify

NCT04499235

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous Pemphigoid

Terminated Phase 2 Results posted Last updated 14 September 2023

What this trial tests

Phase 2 trial testing Mometasone furoate in Pemphigoid, Bullous in 6 participants. Terminated before completion.

Timeline

30 January 2020

Primary endpoint
29 March 2021

14 April 2021

Quick facts

Lead sponsor	Alkahest, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	6
Start date	30 January 2020
Primary completion	29 March 2021
Estimated completion	14 April 2021
Sites	8 locations across Germany

Drugs / interventions tested

Mometasone furoate (MOMETASONE FUROATE) — full drug profile →
AKST4290 — full drug profile →
Placebo

Conditions studied

Pemphigoid, Bullous — all drugs for Pemphigoid, Bullous →

Sponsor

Alkahest, Inc. — full company profile →

Who can join

Adults 60 to 95, any sex, with Pemphigoid, Bullous. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Percentage of Subjects Who Achieve Disease Control Without Rescue Therapy Primary · Baseline to up to 3 weeks (until disease control)

Disease control is defined as ≤ 3 new blisters/eczematous lesions/urticarial plaques/day and healing of existing blisters/eczematous lesions/urticarial plaques without requiring rescue therapy.

Group	Value	95% CI
Mometasone Furoate + AKST4290	2
Mometasone Furoate + Placebo	1

Number of Participants With TEAEs, Assessed by Seriousness and Severity Secondary · Baseline to 5 weeks

Treatment-emergent AEs summarized by MedDRA coding terms; separate tabulations produced for incidence, seriousness and severity of AEs

Subjects Reporting at Least One TEAE

Group	Value	95% CI
Mometasone Furoate + AKST4290	2
Mometasone Furoate + Placebo	1

Subjects Reporting at Least One Serious TEAE

Group	Value	95% CI
Mometasone Furoate + AKST4290	0
Mometasone Furoate + Placebo	1

TEAE by Severity: Mild

Group	Value	95% CI
Mometasone Furoate + AKST4290	2
Mometasone Furoate + Placebo	0

TEAE by Severity: Moderate

Group	Value	95% CI
Mometasone Furoate + AKST4290	0
Mometasone Furoate + Placebo	0

TEAE by Severity: Severe

Group	Value	95% CI
Mometasone Furoate + AKST4290	0
Mometasone Furoate + Placebo	1

Time to Disease Control Secondary · Baseline to up to 3 weeks (until disease control)

Time to disease control by treatment day/week. The time to disease control is calculated as the date of disease control minus Date of Visit 2 (Baseline (Day 1)) plus 1.

Time (Days) to Disease Control: 8

Group	Value	95% CI
Mometasone Furoate + AKST4290	1
Mometasone Furoate + Placebo	0

Time (Days) to Disease Control: 11

Group	Value	95% CI
Mometasone Furoate + AKST4290	2
Mometasone Furoate + Placebo	0

Time (Days) to Disease Control: 15

Group	Value	95% CI
Mometasone Furoate + AKST4290	0
Mometasone Furoate + Placebo	1

Time (Days) to Disease Control: 16

Group	Value	95% CI
Mometasone Furoate + AKST4290	1
Mometasone Furoate + Placebo	0

Time (Days) to Disease Control: 22

Group	Value	95% CI
Mometasone Furoate + AKST4290	1
Mometasone Furoate + Placebo	0

Time to Rescue Therapy Secondary · Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control.

Time to rescue therapy by treatment day/week. The time to rescue therapy is calculated as the start date of the first rescue therapy minus Date of Visit 2 (Baseline (Day 1)) plus 1.

Time (Days) to Rescue Therapy: 4

Group	Value	95% CI
Mometasone Furoate + AKST4290	1
Mometasone Furoate + Placebo	0

Time (Days) to Rescue Therapy 8

Group	Value	95% CI
Mometasone Furoate + AKST4290	1
Mometasone Furoate + Placebo	0

Time (Days) to Rescue Therapy 9

Group	Value	95% CI
Mometasone Furoate + AKST4290	1
Mometasone Furoate + Placebo	0

The Bullous Pemphigoid Disease Area Index (BPDAI) Score Secondary · Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control.

Change from baseline in BPDAI score at End of Treatment (EOT). Subscales for the BPDAI include the skin blister score (range 0-120), skin urticarial score (range 0-120), mucosal activity score (range 0-120), and damage score (range 0-12). Higher scores indicate greater disease activity or damage.

Total BPDAI Skin Blister Score: Baseline

Group	Value	95% CI
Mometasone Furoate + AKST4290	15	± 12.83
Mometasone Furoate + Placebo	13.0

Total BPDAI Skin Blister Score: EOT

Group	Value	95% CI
Mometasone Furoate + AKST4290	7.4	± 7.02
Mometasone Furoate + Placebo	8.0

Total BPDAI Skin Urticarial Score: Baseline

Group	Value	95% CI
Mometasone Furoate + AKST4290	16.4	± 9.15
Mometasone Furoate + Placebo	14.0

Total BPDAI Skin Urticarial Score: EOT

Group	Value	95% CI
Mometasone Furoate + AKST4290	9.2	± 6.38
Mometasone Furoate + Placebo	12.0

Total BPDAI Mucosal Activity Score: Baseline

Group	Value	95% CI
Mometasone Furoate + AKST4290	3.4	± 7.60
Mometasone Furoate + Placebo	0

Total BPDAI Mucosal Activity Score: EOT

Group	Value	95% CI
Mometasone Furoate + AKST4290	1.6	± 3.58
Mometasone Furoate + Placebo	0

Total BPDAI Damage Score: Baseline

Group	Value	95% CI
Mometasone Furoate + AKST4290	5.0	± 4.18
Mometasone Furoate + Placebo	9.0

Total BPDAI Damage Score: EOT

Group	Value	95% CI
Mometasone Furoate + AKST4290	5.0	± 3.81
Mometasone Furoate + Placebo	8.0

The Bullous Pemphigoid Disease Area Index Visual Analog Scale (BPDAI-VAS) Secondary · Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control.

Change from baseline in pruritus as evaluated by the BPDAI-VAS at End of Treatment (EOT). EOT occurs at disease control (up to 3 weeks) or at Week 3 when the subject is discontinued from treatment due to not reaching disease control. Scores for the BPDAI-VAS can range from 0 to 30, with higher scores indicating a worse condition.

BPDAI-VAS Baseline

Group	Value	95% CI
Mometasone Furoate + AKST4290	19.4	± 5.68
Mometasone Furoate + Placebo	15.0

BPDAI-VAS EOT

Group	Value	95% CI
Mometasone Furoate + AKST4290	9.2	± 3.42
Mometasone Furoate + Placebo	4.0

Total Cumulative Steroid Exposure Secondary · Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control.

Total cumulative steroid exposure (cortisol equivalent/kg) by treatment group

Group	Value	95% CI
Mometasone Furoate + AKST4290	260	± 210

Maximum Daily Steroid Dose Secondary · Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control.

Evaluation of maximum daily steroid dose at baseline, by treatment week, and at disease control. Study Day 1 is defined as the initiation of study treatment. 1 mg/kg prednisolon(e) = 5 mg/kg cortisone.

Maximum Daily Steroid Dose Occurred: Day 4

Group	Value	95% CI
Mometasone Furoate + AKST4290	175

Maximum Daily Steroid Dose Occurred: Day 8

Group	Value	95% CI
Mometasone Furoate + AKST4290	150

Maximum Daily Steroid Dose Occurred: Day 11

Group	Value	95% CI
Mometasone Furoate + AKST4290	150

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mometasone Furoate + AKST4290

Serious: 0/5 (0%)

Deaths: 0/5

Mometasone Furoate + Placebo

Serious: 1/1 (100%)

Deaths: 1/1

Serious adverse events (1 terms)

Reaction	System	Mometasone Furoate + AKST4…	Mometasone Furoate + Placebo
COVID-19	Infections and infestations	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Mometasone Furoate + AKST4…	Mometasone Furoate + Placebo
Blood potassium decreased	Investigations	—	—
Rash	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: COVID-19.

Data from ClinicalTrials.gov NCT04499235 adverse events section.

Sponsor's own description

This study will evaluate the therapeutic effect and safety of adjunctive AKST4290 in subjects with bullous pemphigoid (BP).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Advancements in Bullous Pemphigoid Treatment: A Comprehensive Pipeline Update.
Karakioulaki M, Eyerich K, Patsatsi A. · · 2024 · cited 35× · PMID 38157140 · DOI 10.1007/s40257-023-00832-1
A blistering new era for bullous pemphigoid: A scoping review of current therapies, ongoing clinical trials, and future directions.
Khalid SN, Khan ZA, Ali MH, Almas T, et al · · 2021 · cited 17× · PMID 34540212 · DOI 10.1016/j.amsu.2021.102799
The Eotaxin-1/CCR3 Axis and Matrix Metalloproteinase-9 Are Critical in Anti-NC16A IgE-Induced Bullous Pemphigoid.
Jordan TJM, Chen J, Li N, Burette S, et al · · 2023 · cited 11× · PMID 37672029 · DOI 10.4049/jimmunol.2300080
Targeting type 2 inflammation in bullous pemphigoid: current and emerging therapeutic approaches.
Toh WH, Lee HE, Chen CB. · · 2023 · cited 7× · PMID 37614956 · DOI 10.3389/fmed.2023.1196946
Bullous pemphigoid-What do we know about the most recent therapies?
Zeng FAP, Murrell DF. · · 2022 · cited 6× · PMID 36405625 · DOI 10.3389/fmed.2022.1057096
Autoimmune Bullous Diseases: Therapeutic Update.
Kasperkiewicz M, van Beek N, Schmidt E. · · 2026 · PMID 41729378 · DOI 10.1007/s40265-026-02292-3

Verify or expand the search:

Other trials of Mometasone furoate

Trials testing the same drug.

NCT04589663 — Study to Compare the Pharmacokinetics of Mometasone Furoate Alone and in Combination With Indacaterol in Patients ≥ 6 to · Phase 2 · completed
NCT03085797 — Effect of Mepolizumab in Severe Bilateral Nasal Polyps · Phase 3 · completed
NCT02554786 — A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Sa · Phase 3 · completed
NCT00732368 — A Long-term Study of Mometasone Furoate in Patients With Perennial Allergic Rhinitis (Study P04459) · Phase 3 · completed
NCT00779545 — A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED) · Phase 2 · completed

Other Alkahest, Inc. trials

Trials by the same sponsor.

NCT05038020 — A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy · Phase 2 · terminated
NCT04985383 — Study to Compare Safety and Tolerability of AKST1210 Column at 2 Blood Flow Rates in Subjects With ESRD on Hemodialysis · NA · completed
NCT04527328 — A Study to Assess the Tolerability and Efficacy of AKST1210 in Patients on Hemodialysis With Cognitive Impairment · NA · completed
NCT04331730 — A Study to Assess the Efficacy and Safety of AKST4290 With Aflibercept in Patients With Newly Diagnosed nAMD · Phase 2 · completed
NCT04369430 — Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04499235 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alkahest, Inc.
Last refreshed: 14 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04499235.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing