Dermatology clinical trial failures

Phase IV Nail Psoriasis trial by Weill Medical College of Cornell University. Stop reason: OPERATIONAL.

The study was terminated due to slow accrual.

Phase II Dermatitis, Atopic trial by GlaxoSmithKline. Stop reason: OPERATIONAL.

Sponsor decision to early terminate the study following the termination of the parent study (NCT05999799), which met pre-defined futility criterion for efficacy. No safety concerns were identified.

Phase II Wound of Skin trial by Brigham and Women's Hospital. Stop reason: OPERATIONAL.

Due to the insufficient accrual rate and strategic reasons to focus our efforts on higher impact research projects.

Phase I Atopic Dermatitis trial by Yellow Jersey Therapeutics AG. Stop reason: OTHER/UNKNOWN.

Asset acquisition by Johnson \& Johnson. Minimum study objectives necessary to inform safety, tolerability, and dose selection for Phase 2 dose-ranging evaluation of NM26-2198 were achieved, with full completion of all healthy volunteer cohorts.

Phase II Dermatitis, Atopic trial by Janssen Research & Development, LLC. Stop reason: EFFICACY/FUTILITY.

Terminated: futility criteria met at interim efficacy analysis.

Phase II Dermatitis, Atopic trial by GlaxoSmithKline. Stop reason: OPERATIONAL.

Sponsor decision to early terminate the study based on the pre-defined futility criterion for efficacy. No safety concerns were identified.

Phase I Atopic Dermatitis (AD) trial by Good Molecules, LLC. Stop reason: OPERATIONAL.

We have decided to close the study due to recruitment challenges.

Phase IV Atopic Dermatitis trial by Psoriasis Treatment Center of Central New Jersey. Stop reason: OTHER/UNKNOWN.

Principal Investigator retired

Phase IV Palmoplantar Psoriasis trial by Bristol-Myers Squibb. Stop reason: OTHER/UNKNOWN.

Business objectives have changed

Phase III Generalized Pustular Psoriasis trial by Vanda Pharmaceuticals. Stop reason: OTHER/UNKNOWN.

AnaptysBio has concluded the GEMINI-2 trial, with all trial participants having been treated with imsidolimab for approximately six months and the furthest subject having been treated through 104 weeks.

Phase II Atopic Dermatitis trial by RAPT Therapeutics, Inc.. Stop reason: SAFETY.

Study on clinical hold by FDA

Phase II Psoriasis trial by Io Therapeutics. Stop reason: OPERATIONAL.

Sponsor request for study hold

Phase I Radiation Dermatitis trial by Baylor College of Medicine. Stop reason: OTHER/UNKNOWN.

PI is leaving institution and this protocol will not be further pursued at this institution.

Phase II Atopic Dermatitis trial by University of Zurich. Stop reason: OPERATIONAL.

treatment group completed but insufficient recruitment control group

Phase I Atopic Dermatitis trial by Nanjing Immunophage Biotech Co., Ltd. Stop reason: OPERATIONAL.

Sponsor decision

Phase IV Atopic Dermatitis trial by Incyte Corporation. Stop reason: OPERATIONAL.

The study was terminated due to lack of enrollment.

Phase IV Hidradenitis Suppurativa trial by Yale University. Stop reason: OTHER/UNKNOWN.

Study never officially began (or enrolled)

Phase II Atopic Dermatitis trial by Sanofi. Stop reason: OPERATIONAL.

Sponsor decision. Not related to safety concern.

Phase III Dermatomyositis trial by CSL Behring. Stop reason: OTHER/UNKNOWN.

Primary endpoint not attained

Phase II Melanoma (Skin) trial by University of Chicago. Stop reason: OPERATIONAL.

Drug supply no longer available.

Phase I Psoriasis trial by Xencor, Inc.. Stop reason: OPERATIONAL.

Business Decision

Phase II Atopic Dermatitis trial by Eli Lilly and Company. Stop reason: OTHER/UNKNOWN.

The decision to terminate the study was due to efficacy/effectiveness reasons.

Phase IV Severe Atopic Dermatitis (AD) trial by Regeneron Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor Decision

Phase II Myositis trial by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Stop reason: OPERATIONAL.

Manufacturer discontinued investigational drug supply.

Phase IV Psoriasis trial by Assistance Publique Hopitaux De Marseille. Stop reason: OPERATIONAL.

new treatment on the market in direct competition with the new treatment proposed by the study. Recruitment difficulties.

Phase I Atopic Dermatitis trial by Inmagene LLC. Stop reason: OTHER/UNKNOWN.

Cohort 1 was completed. Cohort 2 was cancelled because data from Cohort 1 provided sufficient information for further development decision. No safety concerns were noted.

Phase III Acne Keloidalis Nuchae trial by Icahn School of Medicine at Mount Sinai. Stop reason: EFFICACY/FUTILITY.

Interim analysis did not show any significant differences between groups

Phase I Healthy trial by Eli Lilly and Company. Stop reason: OTHER/UNKNOWN.

Based on emerging nonclinical data, the study was terminated.

Phase II Acneiform Eruptions trial by Vanda Pharmaceuticals. Stop reason: OPERATIONAL.

Administrative Reason

Phase I Atopic Dermatitis trial by Concerto Biosciences. Stop reason: OTHER/UNKNOWN.

Planned safety, efficacy and proof of mechanism obtained

Phase II Parkinson Disease trial by Addex Pharma S.A.. Stop reason: OPERATIONAL.

Terminated prior to completing enrollment goals due to COVID-related difficulties in recruiting patients

Phase II Parkinson Disease trial by Addex Pharma S.A.. Stop reason: OPERATIONAL.

Terminated prior to completing enrollment goals due to COVID-related difficulties in recruiting patients

Phase I Atopic Dermatitis trial by BiomX, Inc.. Stop reason: OPERATIONAL.

Study did not start enrollment due to business reasons

Phase I Psoriasis Vulgaris trial by University of California, San Francisco. Stop reason: OPERATIONAL.

Closing of the Goeckerman program at UCSF and loss of funding, PI left UCSF

Phase II Dermatomyositis trial by EMD Serono Research & Development Institute, Inc.. Stop reason: EFFICACY/FUTILITY.

Based on interim analyses for futility

Phase I Tardive Dyskinesia trial by Yale University. Stop reason: OPERATIONAL.

Lack of funding.

Phase II Nakajo-Nishimura Syndrome trial by Eli Lilly and Company. Stop reason: OTHER/UNKNOWN.

The study was terminated due to efficacy/effectiveness reasons

Phase II Dermatomyositis trial by Alexion Pharmaceuticals, Inc.. Stop reason: OPERATIONAL.

Sponsor decision

Unknown Psoriasis Vulgaris trial by Centre for Human Drug Research, Netherlands. Stop reason: OPERATIONAL.

Early termination was initiated as the recruitment of the remaining 14 moderate-to-severe patients stagnated.

Unknown Mycosis Fungoides of Skin (Diagnosis) trial by Case Comprehensive Cancer Center. Stop reason: OPERATIONAL.

Study closed prior to enrollment of first participant

Early Phase I Psoriasis trial by Wake Forest University Health Sciences. Stop reason: OPERATIONAL.

Terminated IRB approval 6/26/2024, study was never initiated or activated

Phase II Atopic Dermatitis trial by Pfizer. Stop reason: EFFICACY/FUTILITY.

Per the results of the planned interim analysis, the study met futility criteria for efficacy so the trial was terminated. This decision was made for efficacy reasons only and is not due to any safety concerns.

Phase III Polymyositis trial by Janssen Pharmaceutical K.K.. Stop reason: EFFICACY/FUTILITY.

The study did not meet the primary endpoint.

Phase II Seborrheic Dermatitis trial by Icahn School of Medicine at Mount Sinai. Stop reason: EFFICACY/FUTILITY.

The study ended early because interim analysis showed no significant difference between the active and placebo arms.

Phase I Keratoconjunctivitis, Atopic trial by AKARI Therapeutics. Stop reason: OPERATIONAL.

The trial has terminated early due to the disruptions caused by the ongoing COVID-19 pandemic. The decision was not related to any efficacy, safety or clinical concerns regarding rVA576.

Phase II Psoriasis trial by Prof Curdin Conrad. Stop reason: OTHER/UNKNOWN.

External research funds were canceled, so study could unforunately not be continued

Phase IV Psoriasis trial by Janssen-Cilag Ltd.. Stop reason: OPERATIONAL.

Terminated (A strategic decision was made not to further execute the study. This decision was not based on a safety concern)

Phase IV Skin Cancer trial by Charite University, Berlin, Germany. Stop reason: OPERATIONAL.

Insufficient patient recruitment

Phase IV Atopic Dermatitis trial by Boston University. Stop reason: OPERATIONAL.

Funding was stoppped by grantor.

Phase III Psoriasis trial by LEO Pharma. Stop reason: OPERATIONAL.

Early terminated due to difficulty recruiting participants

Phase IV Plaque Psoriasis trial by LEO Pharma. Stop reason: OPERATIONAL.

The recruitment was terminated early due to delays and slow recruitment that significantly jeopardized the trial timelines. There were no safety concerns related to the early termination of the trial.

Phase IV Atopic Dermatitis trial by Murdoch Childrens Research Institute. Stop reason: OPERATIONAL.

Recruitment very slow \& ongoing funding not obtained.

Phase I Other Skin trial by Fred Hutchinson Cancer Center. Stop reason: OPERATIONAL.

Terminated due to insufficient funding

Phase II Melanoma (Skin) trial by The Christie NHS Foundation Trust. Stop reason: OTHER/UNKNOWN.

Closed earlier than expected due to the need for a redesign to reflect the recent change in standard of care guidelines. New design will include these treatments.

Phase II Atopic Dermatitis trial by Akesobio Australia Pty Ltd. Stop reason: OTHER/UNKNOWN.

Clinical study and development strategy adjustment

Phase I Atopic Dermatitis trial by LEO Pharma. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase III Infected Atopic Dermatitis/Eczema trial by LEO Pharma. Stop reason: OPERATIONAL.

Due to business strategic reasons, LEO Pharma has decided to close down the FCF-38 trial.

Phase II Dermatitis, Atopic trial by Boehringer Ingelheim. Stop reason: OPERATIONAL.

Sponsor decision

Phase II Atopic Dermatitis Eczema trial by AnaptysBio, Inc.. Stop reason: EFFICACY/FUTILITY.

ANB032 did not meet the primary endpoint in moderate-to-severe atopic dermatitis

Phase II Melanoma (Skin) trial by Institut du Cancer de Montpellier - Val d'Aurelle. Stop reason: OTHER/UNKNOWN.

In view of the slowness of the inclusions and the difficulty of carrying out the study, it was decided to put an end to this study.

Phase II SCC - Squamous Cell Carcinoma of Skin trial by InflaRx GmbH. Stop reason: OTHER/UNKNOWN.

Sponsor decided to stop the development of vilobelimab in cSCC and early terminated the IFX-1-P2.8 trial due to new alternative treatments for cSCC with high efficacy rates.

Phase IV Dermatochalasis of Eyelid trial by University of Louisville. Stop reason: OPERATIONAL.

Fellow graduated prior to enrollment

Phase II Atopic Dermatitis trial by Stanford University. Stop reason: OTHER/UNKNOWN.

Limited clinical capacity

Early Phase I Skin Neoplasms trial by Riley McLean. Stop reason: OPERATIONAL.

Drug supply issues

Phase I Atopic Dermatitis trial by National Institute of Allergy and Infectious Diseases (NIAID). Stop reason: OPERATIONAL.

Decision to terminate enrollment early was made by the protocol chair and NIAID

Phase IV Atopic Dermatitis trial by LEO Pharma. Stop reason: OPERATIONAL.

Strategic decision

Phase IV Tardive Dyskinesia trial by Stephen Ruedrich. Stop reason: OPERATIONAL.

Not funded

Phase II Atopic Dermatitis trial by Allakos Inc.. Stop reason: OPERATIONAL.

No longer pursuing development

Phase II Dyskinesias trial by Contera Pharma A/S. Stop reason: OPERATIONAL.

The trial is terminated based on business decision, not due to safety concerns or regulatory requirements.

Phase I Skin Aging trial by Mayo Clinic. Stop reason: OTHER/UNKNOWN.

Principal Investigator discretion

Phase II Melanoma (Skin) trial by Wake Forest University Health Sciences. Stop reason: OPERATIONAL.

administrative decision- PI retired and treating physician left the institution

Phase III Skin Flora Bacterial Reduction Post-product Application trial by Solventum US LLC. Stop reason: OTHER/UNKNOWN.

Study discontinued due to data quality issues.

Phase IV Psoriasis Vulgaris trial by University Hospital, Ghent. Stop reason: OTHER/UNKNOWN.

Too slow inclusion rate.

Phase III Atopic Dermatitis trial by AbbVie. Stop reason: OPERATIONAL.

strategic decision

Phase II Psoriasis trial by Ventyx Biosciences, Inc. Stop reason: OPERATIONAL.

Business Decision

Unknown Radiation Dermatitis trial by Stratpharma AG. Stop reason: OPERATIONAL.

Protocol deviations and slow recruitment

Early Phase I Atopic Dermatitis trial by University of Nebraska. Stop reason: OPERATIONAL.

Study never started

Phase I Split Thickness Skin Graft trial by Nantes University Hospital. Stop reason: OPERATIONAL.

It was decided to terminate the study prematurely due to insufficient enrolment, despite extensions to the enrolment period.

Phase I Atopic Dermatitis trial by Brexogen Inc.. Stop reason: OTHER/UNKNOWN.

This study was integrated into BRE-AD01-001 study

Phase IV Actinic Keratoses trial by Royal Cornwall Hospitals Trust. Stop reason: OTHER/UNKNOWN.

Lack of appropriate personnel. Dr Xie abroad on other research, current PI Dr John Frewen not at main centre, no other available PI identified. Study suspended.

Phase III Melanoma (Skin) trial by Carman Giacomantonio. Stop reason: OPERATIONAL.

Low enrollment numbers.

Phase I Plaque Psoriasis trial by Pfizer. Stop reason: OTHER/UNKNOWN.

See termination reason in detailed description.

Phase II Dyskinesias trial by Bukwang Pharmaceutical. Stop reason: OPERATIONAL.

Business reasons

Unknown Seborrheic Dermatitis trial by Ascension Health. Stop reason: OTHER/UNKNOWN.

PI Ryan D Stevenson left Organization (Genesys) prior to Ascension acquiring record; no evidence of completion

Early Phase I Melanoma (Skin) trial by Miltenyi Biomedicine GmbH. Stop reason: SAFETY.

The risk-benefit assessment was not as expected.

Phase III Atopic Dermatitis trial by Vanda Pharmaceuticals. Stop reason: OPERATIONAL.

Business Decision

Phase I Healthy trial by Eli Lilly and Company. Stop reason: EFFICACY/FUTILITY.

Study terminated due to lack of efficacy signal in atopic dermatitis participants.

Unknown Breast Carcinoma trial by OHSU Knight Cancer Institute. Stop reason: OTHER/UNKNOWN.

study staff transition

Phase III Cerebral Palsy, Dyskinetic trial by Teva Branded Pharmaceutical Products R&D, Inc.. Stop reason: OTHER/UNKNOWN.

Failure of TV50717-CNS-30080 (parent study) to meet the primary efficacy endpoint

Phase II Atopic Dermatitis trial by BioMimetix JV, LLC. Stop reason: OPERATIONAL.

Funding constraints

Phase II Acne trial by University of Miami. Stop reason: OPERATIONAL.

Enrollment timeline ended

Phase IV Foot Dermatoses trial by Mahidol University. Stop reason: OTHER/UNKNOWN.

After discussing within the team, the project has been withdrawn due to the anticipated insufficiency of sample size.

Phase II Parkinson's Disease trial by University Medical Center Groningen. Stop reason: OTHER/UNKNOWN.

Delayed inclusion - stopped when 10 patients completed the study

Phase III Plaque Psoriasis trial by Primus Pharmaceuticals. Stop reason: OPERATIONAL.

Not able to recruit patients with the current enrollment criteria.

Phase II Psoriasis trial by Primus Pharmaceuticals. Stop reason: OPERATIONAL.

Difficulty in enrollment

Phase III Plaque Psoriasis trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Low enrollment

Phase III Pruritus trial by Cara Therapeutics, Inc.. Stop reason: OTHER/UNKNOWN.

In Part A of the study, oral difelikefalin as adjunct to topical corticosteroids (TCS) did not demonstrate meaningful clinical benefit compared to TCS alone.

Phase II Solid Tumor trial by Dana-Farber Cancer Institute. Stop reason: OPERATIONAL.

Difficulty with patient recruitment

Phase II Radiation Dermatitis trial by Montefiore Medical Center. Stop reason: OTHER/UNKNOWN.

Study planned but never formally submitted to the IRB

Phase I Dermatitis, Atopic trial by Arjil Pharmaceuticals LLC. Stop reason: OPERATIONAL.

Due to the two AEs in Phase IIa study, recruiting was stopped for safety sake. The study was currently terminated.